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    You are here : Home » MS Research News » Drugs » Tcelna(TM)

    Tcelna(TM)

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    Tcelna (TM) is a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells.

    Late stage clinical study of Tcelna in SPMS initiated

    Opexa LogoOpexa Therapeutics, Inc. a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced the initiation of a Phase IIb clinical trial of Tcelna in patients with Secondary Progressive Multiple Sclerosis (SPMS).

    Several patients have already been enrolled in the study and enrollment is expected to increase rapidly as additional sites begin screening and enrolling patients in the coming weeks. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of SPMS. The therapy is specifically tailored to each patient’s individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients. There is currently only one FDA-approved treatment for SPMS but safety warnings have severely restricted its use.

    The newly initiated trial, named Abili-T, is a randomized, double-blind, placebo-controlled clinical study in SPMS patients who demonstrate evidence of disease progression without associated relapses. The trial is expected to enroll 180 patients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The study will assess a number of clinical endpoints to evaluate the efficacy and safety of Tcelna in patients with SPMS. The primary efficacy outcome of the trial is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate (ARR) and changes in disability as measured by EDSS and the Multiple Sclerosis Functional Composite (MSFC).

    In multiple previously conducted clinical trials for the treatment of patients with MS, Tcelna has demonstrated one of the safest side effect profiles of any marketed or development-stage MS therapy, as well as encouraging efficacy signals indicating Opexa’s therapy may have the potential to be both safe and effective for the treatment of both SPMS and RRMS patients. In Phase I/II studies involving SPMS patients treated with Tcelna (n=36), 80 percent of the patients treated with Tcelna showed no evidence of disease progression at 24 months (a 50% improvement, with respect to patients showing evidence of disease progression, over historical controls). Following two years of treatment, a subset of these patients (n=10) reported no worsening of their physical or psychological condition. Additionally, in 21 years of cumulative follow up in the same SPMS patients treated with Tcelna, the annualized relapse rate for this same subset of patients was reduced significantly compared to baseline and only one patient experienced a relapse during this time.

    “To witness the initiation of this clinical study following the extensive preparations that were required is a tremendous testament to the dedication and talent of the entire Opexa team. We believe this is a critical milestone for not just our Company, but for all of those SPMS patients who desperately need and deserve a better, safer and more effective treatment option,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “We return to the clinic with an enhanced manufacturing process, an optimized clinical development strategy, Fast Track designation from the FDA and the belief that Tcelna is the most promising MS treatment in development today.”

    The initiation of this trial follows a number of key enhancements to the Tcelna clinical development program. First, Opexa has optimized its Chemistry, Manufacturing and Control (CMC) process for the therapy in order to improve efficiency, reduce overall costs and bring it further in line with commercial stage requirements. Following completion of these manufacturing and logistical enhancements, the Company submitted an updated CMC application which has been fully reviewed by the FDA. In addition, the Company has modified its clinical development strategy for Tcelna to focus current efforts on the SPMS patient population in order to address the severe lack of treatment options currently available or in development for these patients. Finally, to reflect its work in optimizing the overall manufacturing process and clinical development strategy for the program, Opexa’s lead product candidate, formerly known as Tovaxin, has been rebranded as Tcelna.

    “It is very gratifying to see Opexa’s novel T-cell therapy return to the clinic and I am excited to be part of the ongoing investigation of a potential MS treatment that possesses such an impressive early safety profile. This is an exceedingly important study for the entire MS community as it will go a long way toward demonstrating how effective the therapy may be for the most in need and underserved progressive MS patient population,” stated Mark Freedman, M.D., director of the Multiple Sclerosis Research Unit at the Ottawa Hospital, member of Opexa's Scientific Advisory Board, and an investigator for the Abili-T trial. “While a positive trial outcome will certainly be good news for SPMS patients, it is also not difficult to envision that it could position Tcelna as a promising treatment for the larger RRMS patient population as well.”

    “The initiation of this clinical trial is a very important milestone in the area of MS research, particularly in light of the significant need for new and effective treatments for these patients,” commented Hans-Peter Hartung, M.D., chairman of the department of neurology at Heinrich-Heine University, Dusseldorf and member of Opexa's Scientific Advisory Board. “As a personalized immunotherapy, Tcelna’s unique mechanism strongly differentiates it from other development stage MS treatments. This combined with a safety profile that is unmatched by other MS therapies currently available or in development positions Tcelna as a potentially very interesting therapy for a large, underserved patient population. Currently, there is no satisfactory treatment available for SPMS patients.”

    While its current clinical trial targets SPMS patients, Opexa also intends to continue the development of Tcelna as a treatment for RRMS patients. Opexa has successfully completed End of Phase II meetings with the FDA and believes it is positioned to initiate Phase III pivotal trials in RRMS patients. Importantly, the results of the ongoing Abili-T trial should further enhance the Company’s future efforts in the RRMS indication. The primary focus at present, however, is the ongoing Phase IIb SPMS Abili-T trial and on securing the necessary capital required for the completion of that trial.

    Source; Herald Online Copywrite Rock Hill Herald Online 2012 (13/09/12)

    Tcelna(TM) announced as new brand name for MS therapy Tovaxin

    Opexa LogoOpexa Therapeutics, a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company is rebranding its leading MS therapy with the new name Tcelna(TM). The product, previously known as Tovaxin(R), will now be known as Tcelna as the company positions itself towards the treatment of patients with Secondary Progressive MS (SPMS).

    "Opexa has worked diligently in the optimization of its overall manufacturing process and clinical development program while concentrating its efforts in the SPMS indication. The rebranding of our lead product as Tcelna encompasses these advancements and our continued dedication to make a difference in the treatment of MS," commented Neil K. Warma, President and Chief Executive Officer of Opexa.

    The name Tcelna (pronounced Te-SELL-nuh) reflects the T-cell derivation of the product. Opexa has requested a registered trademark for the new brand name.

    Source: Market Watch Copyright © 2012 MarketWatch, Inc (21/05/12)

    Tovaxin(R) for MS granted fast track designation by FDA

    Opexa LogoOpexa Therapeutics, Inc. announced today that its lead drug candidate Tovaxin(R) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS).

    The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

    According to the FDA, products with a Fast Track designation often receive priority review, which may offer a significant benefit in that, historically, the review time of a priority product is almost half that of a standard review. Additionally, as per the FDA, Fast Track priority review products are more likely to be approved on the first review cycle than those without the designation. Fast Track also entitles Opexa to more frequent interactions and dialogue with the FDA, further benefiting the development of Tovaxin.

    "Patients with progressive forms of multiple sclerosis (MS) are faced with no proven effective treatment options, so the Fast Track designation for Tovaxin is meaningful as it should enable Tovaxin to move more rapidly through the regulatory process, once it is proven to be efficacious," commented Dr. Mark Freedman, M.D., FRCP, FAAN, Professor of Medicine at the University of Ottawa and Director of the Multiple Sclerosis Research Unit at the Ottawa Hospital. "Novel therapies such as Tovaxin offer hope for patients with a diagnosis of progressive MS."

    "The receipt of Fast Track designation from the FDA represents an important step in our strategy to advance Tovaxin through the clinical and regulatory process," said Neil K. Warma, President & Chief Executive Officer of Opexa. "We look forward to working closely with the FDA throughout the process as we recognize the need to develop a new, efficacious therapy to serve Secondary Progressive MS patients and realize the benefit Tovaxin could offer.

    Based on this positive FDA milestone, our encouraging data in SPMS and supportive discussions with key opinion leaders, clinicians and patients, we have accelerated our plans for SPMS and are planning to initiate a Phase IIb clinical trial with Tovaxin in SPMS subject to securing the necessary resources, while remaining committed to further advancing Tovaxin in Relapsing Remitting MS at a later date. For Opexa, moving forward in progressive MS, an area which we believe represents a higher unmet medical need, could further differentiate the company and Tovaxin from other MS treatments."

    SPMS is characterized by a steady accrual of irreversible disability, despite, in some cases, reversible relapses, remissions, or clinical plateau. Only one product is currently approved in the United States specifically for the indication of SPMS. Opexa believes that a significant unmet medical need exists for the safe and effective treatment of SPMS.

    SOURCE: Opexa Therapeutics, Inc. (08/11/11)

    FDA agree on multiple sclerosis drug study path

    Opexa LogoOpexa Therapeutics Inc (OPXA.O) said it and the U.S. health regulator agreed on the design of a late-stage study to test the company's experimental multiple sclerosis drug, sending its shares up 60 percent.

    The Woodlands, Texas-based company said the U.S. Food and Drug Administration also agreed that the company's new manufacturing process for the drug, Tovaxin, would meet the requirements for a pivotal late-stage clinical trial.

    Tovaxin is a vaccine tailored to individual patients of multiple sclerosis (MS). It helps limit attacks by immune system cells called T-cells on myelin, the protein sheath that protects nerves.

    Opexa plans to submit additional information on chemistry, manufacturing and control process with the regulator before starting a late-stage study. The company also said it was continuing discussions with potential development partners for the drug, while it continues to get funding for the compound's development.

    Source: Reuters © Copyright 2010 Thomson Reuters (05/01/11)

    Opexa reports additional favourable data with Tovaxin for Multiple Sclerosis

    Opexa LogoOpexa Therapeutics, Inc. developing Tovaxin®, a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced results from further analysis of the double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS).

    This analysis evaluated patients with an annualized relapse rate of one or greater at study entry (ARR≥1). More than 83% of the Tovaxin-treated group (n=85) remained relapse free at one year and the annualized relapse rate after treatment decreased to 0.20, a 42% reduction compared to placebo.

    The results of this expanded analysis confirm those found in the previously reported per-protocol analysis of patients in the TERMS study with ARR>1. This post-hoc analysis which represents 86% of the total patient population in the TERMS study was conducted to evaluate Tovaxin treatment among study patients with the same baseline disease activity that is being targeted for inclusion in the forthcoming Phase IIb study. Along with a marked reduction in relapses, 73% of the Tovaxin-treated patients with ARR≥1 showed stabilization or improvement in MS disability, including 16.5% with a sustained improvement in the Expanded Disability Status Scale (EDSS) of at least one full point.

    On MRI, the Tovaxin-treated group also demonstrated a reduction in brain atrophy and fewer inflammatory brain lesions that progressed to "black holes," as compared to the placebo-treated group.

    Treatment with Tovaxin was well tolerated, with no serious adverse events reported in any Tovaxin-treated patient.

    "The expanded analysis represents the MS patient population with active relapsing-remitting disease planned for recruitment into the next Phase IIb trial of Tovaxin," stated Dawn McGuire, MD, a board certified neurologist and a member of Opexa`s Clinical Advisory Board. "Clinical benefits include not only reduction in relapses, but a surprising reversal of disability in over 16% of Tovaxin-treated patients. Along with MRI data suggesting a reduction in neuronal cell loss, these results raise the possibility that Tovaxin-treatment may have neuroprotective as well as disease-modifying effects. Tovaxin`s favourable safety profile and these early efficacy signals strongly support moving forward with a confirmatory Phase IIb trial."

    Tovaxin is a personalized T-cell vaccine based on a patient`s individual immunologic profile. Detailed immunology data analysis from the TERMS trial indicate that Tovaxin can successfully induce changes in T-cell reactivity to all three targeted myelin antigens implicated in the autoimmune attacks causing neurologic damage in MS. These changes appear epitope-specific, are sustained for 6 months or more, and match each patient's Tovaxin formulation. Tovaxin is not broadly immunosuppressive, an important feature of its favourable safety profile.

    "From an immunology perspective, the data generated thus far from the TERMS trial, from thousands of patient samples, appear to correlate nicely with the putative mechanism of action for Tovaxin. While additional analyses are still in progress, we are also seeing early associations between depletion of myelin reactive T-cells and favorable clinical outcomes," commented Dr. McGuire.

    Source: Opexa Therapeutics, Inc. (08/09/09)

    Opexa provides key quality of life data on Tovaxin® for Multiple Sclerosis

    Opexa Logo

    Opexa Therapeutics, Inc. announced an update on the continuing analysis of the company's Phase IIb TERMS clinical trial (Tovaxin® for Early Relapsing Multiple Sclerosis) for the treatment of MS. An analysis of the MS Quality of Life Inventory Data (MSQLI) from the 150 patient study has shown that in the complete modified intent to treat (mITT) population (n=142), patients treated with Tovaxin demonstrated a statistically significant improvement in the Impact of Visual Impairment Scale scores (p=0.028) compared to those on placebo. This improvement was observed within six months of completing the full course of treatment.

    Visual problems are a common, often disabling symptom in MS and according to the National Multiple Sclerosis Society can affect over 40% of patients. The Impact of Visual Impairment Scale consists of 5 items that assess the extent to which various activities dependent upon vision are affected by MS-related visual problems. In the other measures defined by the Health Status Questionnaire (SF-36) there was no significant change or worsening in any of the additional ten components comprising the evaluation.

    In a further analysis of the MSQLI data in patients with more active disease that comprise the prospective cohort at the center of the company?s evaluation (n=50), patients treated with Tovaxin demonstrated a statistically significant improvement in the Medical Outcomes Study Social Support Survey score compared to those on placebo (p=0.005). Similarly, there was no significant change or worsening in any of the other evaluable parameters within the prospective cohort.

    An abstract highlighting key clinical, magnetic resonance imaging (MRI), epitope and Quality of Life data from the landmark TERMS study has been accepted as a poster presentation at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009. The presentation will be given by Edward Fox, MD, PhD, director of the Multiple Sclerosis Clinic of Central Texas and the study?s principal investigator and co-author of the TERMS study.

    "The continuing analysis of the Tovaxin data has yielded numerous interesting pieces of data, and I am looking forward to presenting some of these at the AAN meeting. A subgroup analysis of patients with more active MS supports the efficacy and superior safety of this therapy for the treatment of MS," stated Dr. Fox. "Since the manufacturing of Tovaxin is tailored to match each individual?s disease profile, the potential benefit to patients could be substantial."

    "We continue to advance our partnering discussions for both our T-cell technology in MS and stem cell technology in diabetes and are evaluating a number of strategic opportunities," commented Neil K. Warma, Opexa's president and chief executive officer. "The addition of the MSQLI data further demonstrates that Tovaxin continues to hold significant promise as one of the safest and most effective treatments for MS currently in development, a market that currently exceeds $6 billion and yet a disease area with a continuing severe unmet medical need."

    About the TERMS study

    Data from the TERMS Phase IIb clinical study with Tovaxin in MS demonstrated the following:

    Promising Efficacy in patients with more advanced disease

    55% reduction in the Annualized Relapse Rate (ARR) observed in Tovaxin treated patients

    87% reduction in ARR observed in Tovaxin patients after the full course of treatment was administered (p=0.039)

    Statistically significant improvement in disability (p=0.045) as measured by EDSS observed in Tovaxin treated patients (28.1% showing improvement with Tovaxin vs. 5.6% with placebo)

    88% reduction in brain atrophy when treated with Tovaxin

    59% reduction in absolute T-2 lesion volume

    Excellent Safety

    No serious adverse events (SAEs) associated with Tovaxin treatment in the Phase IIb TERMS study

    No serious adverse events associated with Tovaxin in either of the previously conducted Phase I/II clinical studies

    Ease of Administration

    Patient compliance may be improved with Tovaxin?s treatment regimen of five subcutaneous injections per year

    Epitope data

    An analysis of the immunology data collected from several thousand patient samples is yielding valuable information on MS biomarkers and Tovaxin mechanism of action

    Tovaxin appears to reduce myelin peptide reactivity and reduce the risk of relapse over time.

    Source: Opexa Therapeutics, Inc.(05/03/09)

    Opexa seeking partner for Multiple Sclerosis treatment, Tovaxin® development

    Opexa Logo

    Since providing additional data analysis for its TERMS Phase IIb clinical trial in October, Opexa has been actively engaged in discussions to partner Tovaxin®, its lead therapy and novel treatment for MS, as it positions itself for pivotal trials and future commercialisation.

    To further support the ongoing discussions and advance the clinical development of Tovaxin, Dawn McGuire, M.D., a member of Opexa’s Clinical Advisory Board, has agreed to increase her advisory role to the company and guide clinical development of Tovaxin. Dr. McGuire, a board-certified neurologist, has experience in all phases of drug and biologic development for multiple sclerosis. While Vice President of Clinical Research and Medical Affairs at Elan Pharmaceuticals, she was the development team leader for Tysabri.

    "Tovaxin offers the potential for immunomodulatory treatment that is exquisitely individualized for a complex disease that manifests in a highly individual manner. Early results with Tovaxin suggest reduction not only in relapse rates but also in global neuronal loss among patients with the most active disease. I see great promise here,” commented Dr. McGuire.

    Opexa has promoted Donna Rill to Senior Vice President of Operations. She will continue to oversee the production and manufacturing of all cell therapy programs and will focus on the upcoming end of Phase II meeting with the FDA and the scale up of operations to support future Tovaxin trials in North America and Europe.

    Dr. Jim Williams, Chief Operating Officer, will retire from the company, effective February 13, 2009 after several years of overseeing the clinical development of Tovaxin. He will remain available in a consulting capacity to assist with any transition.

    “With possibly the safest therapy for MS demonstrated to date and some very encouraging efficacy data in clinically relevant relapse rates and disability scores, we are pleased with the level of discussions we are having with potential partners,” commented Neil K. Warma, President and CEO of Opexa Therapeutics, Inc. “We are extremely fortunate to have someone of Dr. McGuire’s experience to further advise on our clinical development strategy and steward the clinical development of Tovaxin. Her substantial knowledge and experience in MS, having overseen the early development of Tysabri will certainly contribute very favorably to our development program and partnering discussions. We are grateful to Jim for having contributed immensely to the development of Tovaxin to date and for overseeing the management of the first-in-class TERMS IIb study and we are pleased he will remain a consultant to the company as we continue forward with our clinical strategy.”

    About the TERMS Study

    The TERMS study was a Phase IIb multi-center, randomized, double blind, placebo-controlled trial in 150 patients with Relapsing-Remitting Multiple Sclerosis or high risk Clinically Isolated Syndrome. The study involved 2:1 randomization with 100 patients receiving Tovaxin and 50 receiving placebo. According to the study protocol, patients received a total of five subcutaneous injections at weeks 0, 4, 8, 12 and 24. The primary efficacy endpoint of the TERMS trial was the cumulative number of gadolinium-enhanced brain lesions (CELs) using MRI scans summed over weeks 28, 36, 44 and 52. The trial’s secondary efficacy endpoints included annualized relapse rate (ARR), new CELs at weeks 28 through 52 and T2-weighted lesion volume compared to baseline.

    Data from the TERMS Phase IIb clinical study with Tovaxin in MS demonstrated the following:

    Promising Efficacy – The Annualized Relapse Rate (ARR) for the prospective group of patients with a greater level of disease burden was 0.28 relapses per patient per year. Remarkably, the ARR for this group dropped to 0.07 after the full course of treatment was administered. Additionally, this group showed a statistically significant improvement in disability (p=0.045) and a substantial improvement in brain atrophy when treated with Tovaxin.

    Excellent Safety - There were no serious adverse events (SAEs) associated with Tovaxin treatment in the TERMS study. This is consistent with the previous clinical trials with Tovaxin, all of which showed no SAEs associated with Tovaxin treatment. This is an especially critical finding given the recent serious side effect occurrences associated with certain marketed and developmental MS products and the ongoing regulatory focus on risk/benefit relationships.

    Ease of Administration - Patient compliance may be improved with Tovaxin’s treatment regimen of five subcutaneous injections per year.
    Epitope data - An analysis of the immunology data collected from several thousand patient samples is yielding valuable information on MS biomarkers and Tovaxin mechanism of action. Tovaxin appears to reduce myelin peptide reactivity and reduce the risk of relapse over time.

    About Tovaxin for MS

    Tovaxin is an individualized T-cell therapeutic vaccine that consists of attenuated patient-specific myelin-reactive T-cells against peptides of proteins from Myelin basic protein (MBP), Myelin oligodendrocyte glycoprotein (MOG) and Proteolipid protein (PLP) or combinations thereof. Tovaxin’s dual mechanism of action combats the demyelination of the nerve fibers in the central nervous system, the underlying cause of MS. Clinical results have demonstrated that Tovaxin produces the following therapeutic effects:

    Anti-idiotypic effect - Induces an immune response that depletes and regulates the circulating pathogenic myelin-reactive T-cells that attack the myelin sheath of nerve fibers.

    Anti-ergotypic effect - Rebalances the overall immune system by causing a shift from pathogenic inflammatory T-cells to anti-inflammatory T-cells.
    Tovaxin is manufactured in Opexa’s in-house cGMP facility.

    Source: Opexa Therapeutics, Inc. (21/01/09)

    Tovaxin(R) demonstrates reduction in disability, relapse risk and myelin T-cell reactivity in patients with Multiple Sclerosis

    Opexa Therapeutics, Inc. announced additional positive data from the company's Phase IIb TERMS clinical trial (Tovaxin(R) for Early Relapsing Multiple Sclerosis).

    The latest analysis focused on a prospective group of patients (n=50) with an annualized relapse rate (ARR) of greater than 1 at study entry which is comparable to ARR baselines of patients in previous Tovaxin studies. These findings demonstrate a statistically significant improvement in disability as measured by the Expanded Disability Status Scale (EDSS) (p=0.045) for patients treated with Tovaxin as compared to those receiving placebo. In this group, 28.1 percent of patients treated with Tovaxin showed an improvement in EDSS as compared to only 5.6 percent in the placebo group.

    Additionally, there was an 88 percent reduction in the level of brain atrophy and a more than 20 percent reduction in the number of gadolinium (Gd) lesions progressing to black holes in the Tovaxin group, which may suggest a beneficial neuroprotective effect. Overall, the analysis shows that patients treated with Tovaxin demonstrated a benefit across all clinical and magnetic resonance imaging (MRI) endpoints (primary, secondary and tertiary) in this patient population.

    Immunology data also appears to support Tovaxin's mechanism of action, indicating that patients with less myelin T-cell reactivity have a lower risk of relapse. Additional quality of life measurements, such as the Timed 25 foot Walk, also showed a benefit for Tovaxin over placebo (0.14 vs. -0.02, as measured by respective Z scores).

    The data shows that these patients when treated with Tovaxin demonstrate an ARR of 0.28 which represents a 55 percent reduction compared to those patients on placebo. This relapse rate is on par with the lowest relapse rates observed with currently available MS treatments which range from 0.2 to 0.9. Study findings also show Tovaxin possesses an impressive safety and tolerability profile. Opexa expects to conduct a Phase II close-out meeting with the United States Food and Drug Administration during the first half of 2009 to discuss next steps for the further clinical development of Tovaxin. Opexa is actively engaged in discussions with potential strategic partners for the Tovaxin program.

    The TERMS study provided Opexa the opportunity to create a comprehensive database of clinical immunology and epitope data in MS patients that may significantly advance the understanding and treatment of the disease. This type of information is particularly important for Opexa as Tovaxin's dual mechanism of action involves the depletion of myelin-reactive T-cells in the peripheral blood and the regulation of anti-inflammatory T-cells to rebalance an MS patient's immune system.

    Previous studies show that if the myelin-peptide reactivity in a patient's peripheral blood is reduced, the clinical symptoms associated with MS will also be reduced. The initial analysis of the study's immunology and epitope database has shown that patients treated with Tovaxin appeared to have less myelin-peptide reactivity over the course of the study than those on placebo. This was measured using Opexa's proprietary Epitope Analysis Assay (EAA) which assessed reactivity across all three key myelin proteins at several time points throughout the 52-week study.

    Additionally, over the full course of treatment, more patients on Tovaxin remained in the lower quartile of peptide reactivity (56 percent) than those on placebo (39 percent). This epitope data appears to correlate with the study's MRI and clinical endpoints which, among other findings, showed that following the full course of treatment (weeks 28-52), the ARR in the Tovaxin group dropped to 0.065 (0.749 for placebo).

    The pattern emerging from the analysis of the immunology and epitope database suggests that those patients exhibiting a higher T-cell reactivity often demonstrated a worsening of at least one MRI endpoint (Gd lesion, Gd volume, new T2 count or progression to black holes) and one clinical endpoint (either relapse or EDSS). The converse also appears true with less T-cell reactivity implying less or no worsening of certain MRI and clinical endpoints.

    Additionally, the immunology data shows that reactivity to all three of the key myelin proteins (MOG, PLP and MBP) was broadly present in study patients, which may be an important finding for the future treatment of MS. Opexa is also assessing which specific peptides from each of the proteins may provide the most relevant targets for the company to enhance its manufacturing process and further strengthen its intellectual property portfolio.

    "Tovaxin seems to be demonstrating a benefit to these patients as indicated by immunology, MRI and clinical parameters," stated Dr. Clyde Markowitz, associate professor of neurology and director of the MS center at the University of Pennsylvania School of Medicine. "This is interesting data and additional trials are certainly warranted to further explore the potential of this novel treatment."

    Previously reported top-line results from the TERMS study demonstrated that Tovaxin was safe and well tolerated with no serious adverse events related to treatment. The most common adverse event related to Tovaxin was mild injection site reaction. Continued analysis of safety and tolerability data has confirmed these top-line results with no serious adverse events observed in any Tovaxin-treated patients during the entire study.

    "This landmark first-in-class study has yielded impressive results for Tovaxin in MS patients with high disease burden, including a marked reduction in disability, relapse risk and levels of T-cell reactivity. These findings are very encouraging and we are eager to continue the clinical development of this novel therapeutic," commented Neil K. Warma, president and chief executive officer of Opexa Therapeutics.

    "There remains a tremendous unmet medical need for MS patients, and we believe a safe and effective patient-specific treatment may generate considerable interest among regulatory authorities, patients, physicians and potential strategic partners. With this in mind, we remain committed to aggressively pursuing our two primary objectives: the continued development of Tovaxin towards a pivotal Phase III trial and a high-value partnership for the Tovaxin program. With the MS market exceeding $6 billion and growing, we believe Tovaxin is very competitively positioned from a safety, efficacy and patient compliance perspective."

    About the TERMS Study
    The TERMS study was a Phase IIb multi-center, randomized, double blind, placebo-controlled trial in 150 patients with Relapsing-Remitting Multiple Sclerosis or high risk Clinically Isolated Syndrome (CIS). The study involved 2:1 randomization with 100 patients receiving Tovaxin and 50 receiving placebo. According to the study protocol, patients received a total of five subcutaneous injections at weeks 0, 4, 8, 12 and 24. The primary efficacy endpoint of the TERMS trial was the cumulative number of gadolinium-enhanced brain lesions (CELs) using MRI scans summed over weeks 28, 36, 44 and 52. The trial's secondary efficacy endpoints included annualized relapse rate (ARR), new CELs at weeks 28 through 52 and T2-weighted lesion volume compared to baseline.

    Source: Opexa Therapeutics, Inc. (23/10/08)

    Tovaxin, injectable multiple sclerosis treatment, fails to meet primary endpoint in a midstage study

    Opexa Logo

    Opexa Therapeutics Inc. said its lead drug candidate aimed at treating multiple sclerosis failed to meet its main goal in a midstage study.

    Opexa said the results for Tovaxin showed a "positive trend" in reducing the annual relapse rate for multiple sclerosis patients, compared with placebo. Multiple sclerosis is an autoimmune disorder that results in physical and neurological damage.

    The company partially blamed the results on a higher number of brain lesions seen in Tovaxin patients before they started treatment, as compared with those on placebo, meaning they were more difficult to treat from the start of the study.

    Instead, the company focused on the drug's safety and tolerability in treating the condition. Patients taking Tovaxin had a 37 percent reduction in the relapse rate compared with placebo.

    "This level of safety and tolerability addresses a critical unmet need for multiple sclerosis patients," President and Chief Executive Neil K. Warma said in a statement. "We believe that these positive ARR (relapse rate) results combined with an excellent safety profile and convenient dosing place Tovaxin in a very favorable position for continued development as an innovative multiple sclerosis therapy."

    The Phase IIb clinical trial involved 150 patients.

    Source: Associated Press Copyright 2008 Associated Press (22/09/08)

    Opexa Therapeutics and Myelin Repair Foundation partner on novel Multiple Sclerosis research program

    Opexa Logo  Myelin Repair Foundation Logo

    Opexa Therapeutics, Inc. announced the establishment of a novel Multiple Sclerosis research partnership with the Myelin Repair Foundation, Inc. As part of this collaboration, Opexa and the MRF will work to identify therapeutically relevant biomarkers in MS that may provide important insight to support the continued development of Tovaxin(R), Opexa's T-cell vaccine currently in Phase IIb clinical testing in MS patients. In addition, biomarkers identified as part of the research program may also assist in guiding the discovery and development of novel diagnostics and treatments for MS.

    Under terms of its collaboration with Opexa, the MRF will receive and analyze patient samples and clinical data from Opexa's Phase IIb clinical study with Tovaxin to identify biomarkers related to safety and efficacy of the therapy in MS patients. As part of this analysis, the MRF will leverage its network of leading MS researchers, as well as its proprietary biochemical and biological assays which are designed for the discovery and characterization of novel biomarkers that may have clinical use in diagnosing and/or treating MS.

    "Through our collaboration with Opexa and our analysis of patient samples from the Tovaxin Phase IIb study, we hope to discover novel therapeutic, diagnostic and surrogate biomarker targets of components and pathways involved in the destruction, repair and re-myelination of axons in the central nervous system," said Russell Bromley, chief operating officer of the MRF. "Research has shown that MS attacks individual patients differently. Accordingly, we expect that clinical samples from this study, in which T-cell vaccines were tailored for each subject, will help us better understand how we can identify specific myelin repair therapeutic targets to assist in the rapid development and commercialization of personalized MS treatments."

    The collaboration will be jointly managed by research and development experts from Opexa and the MRF. Under terms of the agreement, each party will own all program intellectual property that is conceived of solely by its representatives. Intellectual property that is conceived of collaboratively will be jointly owned by both Opexa and the MRF with Opexa retaining the option to negotiate an exclusive license for any of the collaboration's joint intellectual property or that which is solely owned by the MRF.

    The MRF is a non-profit medical research foundation dedicated to accelerating basic medical research into myelin repair treatments aimed at dramatically improving the lives of people suffering from MS. The group's innovative Accelerated Research Collaboration(TM) (ARC) model involves the establishment of collaborations with a number of leading MS researchers at prestigious institutions who agree to work jointly to develop and conduct experiments that will lead to targeted myelin repair discoveries. To date, the MRF has entered into collaborations with researchers at Stanford University, Northwestern University, University of Chicago and Case Western Reserve University.

    "Organizations such as the MRF are critical to the discovery and development of safe and effective MS therapies, and data generated from the MRF's analysis of the patient samples from our Phase IIb Tovaxin study will provide valuable insight into the treatment of the disease," stated Jim Williams, Ph.D., chief operating officer of Opexa. "Together with the MRF, we have the potential to uncover breakthroughs in an area of important medical research, discover additional promising MS therapies for development under Opexa's T-cell platform, and gain invaluable data to guide the appropriate design of future clinical trials with Tovaxin to support future regulatory filings for the biologic."

    Opexa is currently evaluating Tovaxin in 150 patients in a multi-center, randomized, double-blind, placebo-controlled Phase IIb clinical trial in patients suffering from Relapsing-Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS). The company expects to announce top-line results from the Phase IIb study in September 2008.

    Source: Opexa Therapeutics, Inc. (03/09/08)

    Additional analysis on phase I/II extension study with Tovaxin(R) for Multiple Sclerosis conducted by Opexa

    Opexa Therapeutics, Inc. has completed an internal assessment of data from its Phase I/II two year extension study with Tovaxin in patients with MS. While confirming the favorable safety and efficacy profile of Tovaxin, further analysis also confirms both the benefit of consecutive annual treatments with Tovaxin and the advantage of tailoring each vaccination to the patient’s changing disease profile.

    The extension study evaluated 22 intent-to-treat patients that had enrolled in two Phase I/II open-label clinical studies with Tovaxin. 13 patients were enrolled with Relapse Remitting Multiple Sclerosis (RRMS) and 9 with Secondary Progressive Multiple Sclerosis (SPMS). After the first annual course of treatment the company conducted an analysis of each patients specific disease profile and myelin peptide epitope profile using Opexas proprietary Epitope Analysis Assay (EAA). The analysis showed that 19 of the 22 patients (86%) had undergone an epitope shift, or change in disease pattern since the original course of treatment. Based on the epitope analysis, Opexa manufactured a new and specific vaccine for each of these patients for their second course of treatment. This enabled Opexa to tailor each vaccine to the individuals current disease profile, thereby maximizing the effect.

    The treatment regimen of five subcutaneous injections per year for each of the two years with two different vaccines tailored to each patients disease profile produced promising results. Pooled data from the RRMS and SPMS patients showed that, as a group, 73% remained relapse free after two years and 86% demonstrated no worsening of disease (27% of these showed sustained improvement). Additionally, there was an overall decrease in the Annualized Relapse Rate (ARR) of 82% (from 1.38 to 0.21 relapses/patient/year). Each of these endpoints was compared to the patients own baseline reading, taken prior to enrollment in the trials.

    A further analysis of several effectiveness parameters showed that Tovaxin effectively decreased the number of circulating Myelin Reactive T-Cells (MRTCs) but did not cause any detectable reduction in the general lymphocyte populations. The lack of generalized immune suppression observed at this stage of development is one important aspect that distinguishes the safety of Tovaxin from certain marketed drugs. Side effects observed over the two year treatment period have been limited to moderate injection site reactions. There have been no serious adverse events related to treatment.

    The results from this extension study support our clinical strategy for Tovaxin of annual treatments tailored to each patients clinical disease state, commented Dr. Jim Williams, Opexas Chief Operating Officer. And although the safety and efficacy data from the two year Tovaxin studies are based on a limited MS patient sample across two open-label clinical studies, comparing the annualized relapse rates of the RRMS patient population treated with Tovaxin at 0.2, places this treatment at the lower end of documented relapse rates of the major marketed drugs which range from 0.2-0.9. We believe Tovaxins safety profile and a treatment regimen of five subcutaneous injections per year will also position the therapy favorably from a patient compliance perspective, added Dr. Williams.

    The company is currently completing a larger Phase IIb study in 150 patients in a multi-center, randomized, double blind, and placebo-controlled study in patients with RRMS or Clinically Isolated Syndrome (CIS). The company expects to announce top line results in September 2008.

    Source: Opexa Therapeutics, Inc. (22/07/08)

    Favourable Two-Year Data in Phase I/II Retreatment Studies of Tovaxin® for Multiple Sclerosis
    Opexa Therapeutics, Inc. announced favourable safety and efficacy data for Tovaxin®, the Companys investigational T-cell vaccination therapy for multiple sclerosis (MS), in the second year of open-label clinical retreatment studies in patients with MS.

    The intent to treat population of 22 patients included 13 with relapsing remitting multiple sclerosis (RRMS) and nine with secondary progressive multiple sclerosis (SPMS). An analysis of disease progression of disability over a two year period, as measured by a 1.0 or greater change in Expanded Disability Scoring Scale (EDSS), showed that 27.3% of patients demonstrated sustained improvement, 59.1% had no disease progression and 13.6% experienced sustained worsening of disability. The improvement in the EDSS scores ranged from 1.0 to 4.5 (average 2.41). During the two-year study period 72.7% of patients remained relapse-free.

    Brian Loftus, M.D., of Bellaire Neurology and the principal investigator of the studies, commented, Im pleased to see that subjects in the study experienced sustained positive clinical outcomes over the two-year period. It was especially encouraging to see a lack of disease progression in more than 86% of the patients after two years, given the later stage of disease of this subject population.

    The annualized relapse rate analysis of 17 patients (which excludes five patients with no prior relapses in their two-year pre-study baseline) showed Tovaxin therapy achieved an 82% reduction in annualized relapse rate (ARR) in patients over a two-year period (p<0.0001) to 0.21 relapses per year, compared with 1.38 relapses per year in the patients prior two-year baseline. For RRMS patients (n=12) the ARR over a two-year period was 0.26 relapses per year, compared with 1.63 relapses per year in the patients prior two-year baseline; for SPMS patients (n=5) the ARR over a two-year period was 0.10 relapses per year, compared with 0.80 relapses per year in the patients prior two-year baseline.

    Approximately three out of four patients re-treated in the second year exhibited a change in their myelin-reactive T-cell profile, which was the basis for producing their individualized T cell vaccine, said David McWilliams, president and chief executive officer of Opexa. We believe this new data supports the continuation of our development strategy of individually monitoring patients with our proprietary epitope analysis assay and re-treating them with a patient-specific therapeutic vaccine that associates with their clinical status.

    The combined analysis included patients participating in second-year extension protocols from the Phase I/II dose-escalation study and the Phase I/II re-treatment study, and 19 of 22 patients were re-treated with Tovaxin during the study period. Patients did not receive any other disease modifying therapies during the two-year study period.

    Tovaxin was well-tolerated throughout the two-year study period. The safety profile revealed only mild-to-moderate injection site reactions and no serious adverse reactions related to T-cell vaccination.

    Source: Opexa Therapeutics, Inc. (12/06/08)

    Persistence of Myelin Reactive T-cells in Relapsing-Remitting Multiple Sclerosis Patients Receiving Immunomodulatory Treatment
    Multiple Sclerosis (MS) patients frequently have circulating myelin reactive T-cells (MRTC) as detected by an epitope analysis screening assay (EAA). The EAA measures proliferative responses of patient peripheral T-cells upon exposure to peptides of myelin proteins. Patient-specific T-cell lines for Tovaxin® vaccine formulation are then generated using synthetic peptides across myelin basic protein, proteolipid protein, and myelin oligodendrocyte glycoprotein.

    As a prelude to the Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase IIb clinical study, 30 relapsing-remitting MS (RRMS) patients on various immunomodulatory therapies were evaluated for MRTC using the EAA. At the time of blood draw 11 subjects were being treated with glatiramer acetate, 11 were being administered beta-interferon, and 8 patients were not taking immunomodulary medication. Of the 30 subjects screened in this cohort, MRTC were detectible in 19 patients (63.3%). When stratified by therapy, 8/11 glatiramer acetate users (72.7%), 7/11 beta-interferon users (63.6%), and 4/8 patients not on MS therapy (50.0%) were positive for MRTC activity. Reactivity among subjects varied from 1 -12 peptides and were present across all three major myelin proteins. The study was conducted at a single site by Edward J. Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas.

    This study indicates that certain immunomodulatory agents used in MS treatment may not completely suppress circulating MRTC and that the EAA can be used to assess patient-specific MRTC profiles, said Dr. Fox.

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in MS patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in some patients treated in earlier clinical studies.

    Source: Opexa Therapeutics, Inc. (22/05/08)

    Completion of Mid Study Descriptive Analysis on Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
    Opexa Therapeutics, Inc, today announced that the independent Data Safety Monitoring Board (DSMB) of its ongoing 150-patient Phase IIb safety and efficacy study (TERMS) of Tovaxin in multiple sclerosis recommended that the trial be continued as scheduled.

    Opexas Data Safety Monitoring Board is an independent group of multiple sclerosis experts which is responsible for monitoring the ongoing safety and conduct of the study. At each DSMB meeting, the board may recommend continuing the trial unmodified, continue the trial with modifications or discontinue the trial.

    The DSMB meeting reviewed 28-week data for approximately 50% of the patients in the study. The DSMB noted in their report very few dropouts and that the study appears to be proceeding well. In addition, the report indicated that baseline MRI data is consistent with the assumptions used in the design of the study. Edward Fox, M.D., Ph.D. commented, "As the lead investigator of the TERMS trial, I continue to anticipate the conclusion of this experimental protocol, which has been designed to evaluate the efficacy, tolerability, and safety of Tovaxin in the treatment of patients in the early stages of Multiple Sclerosis."

    David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "I am pleased by the steady progress of the trial and the recommendation of the DSMB. We have delivered all Tovaxin doses to patients in the study and now look forward to presenting 52-week topline results of the TERMS Phase IIb study in September". McWilliams continued, with this report, we are aggressively moving forward with our regulatory plans and furthering our discussion with potential strategic development partners."

    About TERMS Descriptive Analysis

    The descriptive analysis provided to the DSMB included clinical laboratory results, adverse events, vital signs and physical examination data as well as the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans, the cumulative number of new gadolinium-enhancing lesions, the change in T2-weighted lesion volume, and annualized relapse rates. Disease progression, as measured by changes in disability scores using the industry-standard Kurtzke Expanded Disability Status Scale (EDSS) along with other select qualitative/quantitative MS-specific instruments, was also assessed.

    About TERMS

    The Tovaxin Phase IIb clinical study includes 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in some patients treated in earlier clinical studies.

    Source: Opexa Therapeutics, Inc.(11/03/08)

    Opexa Therapeutics Gives Update on Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
    Opexa Therapeutics, Inc, a company involved in the development and commercialisation of cell therapies, today provided an update on its 150-patient Phase IIb safety and efficacy study (TERMS) of Tovaxin® in multiple sclerosis. The trial design is a U.S. multicenter, randomised, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS).

    Trial Highlights:

    • All 150 patients have received their first vaccine dose in the five dose vaccine series.
    • More than 60% of the total 750 vaccine doses of the study have been delivered.
    • Individualised Tovaxin formulations for all 150 patients have been manufactured with more than 95% of them being unique myelin epitope profiles as identified by Opexa's Epitope Analysis Assay. The variety among the formulations highlights the diversity of myelin epitopes contributing to the disease and supports the individualized therapy approach of Opexa's Tovaxin therapy.
    • The Data Safety Monitoring Board has met three times and reported no safety issues and recommends continuing the trial as planned.

    David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "I am pleased by the steady progress of the trial and recommendation of the Data Safety Monitoring Board and we now look forward to reporting 52-week results in the second half of 2008." McWilliams continued, "We are encouraged that the diverse myelin peptide reactive profile of each patient that we have identified thus far in the study brings us closer to realizing the promise of individual therapy in general, and specifically supports our individualised therapy approach to the treatment of multiple sclerosis."

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

    About TERMS

    The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    Source: Opexa Therapeutics, Inc (11/09/07)

    Opexa Therapeutics Receives European Patent Notification for T-Cell Vaccine
    Opexa Therapeutics, Inc, a company involved in the development and commercialization of cell therapies, today announced that it has received notification under Rule 51(4) from the Examining Division of the European Patent Office (EPO) that the EPO intends to issue a patent for Autologous T Cell Vaccine Materials and Method. The European patent application is related to a unique method-specific approach for generating a T-cell vaccine that attacks what is believed to be the underlying cause of multiple sclerosis (MS). Rule 51(4) EPC notification is equivalent to a Notice of Allowance by the United States Patent and Trademark Office. It is expected that the patent will be granted within the next six months.

    David McWilliams, president and chief executive officer of Opexa Therapeutics, commented, This is an important step in advancing our intellectual property strategy for Tovaxin®, T-cell vaccine for the treatment of MS. Europe represents a significant market as we move forward with our clinical development of Tovaxin and we are pleased that our method has been recognized as being unique.

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients. Tovaxin is currently in a Phase IIb clinical trial. Patients treated in Opexas Phase I/II open-label studies have experienced an approximately 90% average reduction in annualized relapse rate, minimal side effects and observed improvement in average disability (EDSS) scores.

    Source: Opexa Therapeutics Inc. (13/08/07)

    Opexa Reports Positive Results In Phase I/II Extension Clinical Trial Of Tovaxin For Multiple Sclerosis

    Opexa Therapeutics Inc. reported positive results in an open-label Phase I/II extension clinical trial of its investigational T-cell vaccine, Tovaxin, for multiple sclerosis. T cell is a type of white blood cell that attacks virus-infected cells, foreign cells, and cancer cells.

    The one-year extension clinical trial enrolled 8 subjects. Tovaxin therapy achieved a 92% reduction in annualised relapse rate in patients who received two treatment doses of Tovaxin eight weeks apart and were monitored for an additional 44 weeks. Patients enrolled in the extension clinical trial were earlier treated with a T-cell vaccine developed from myelin basic protein reactive T-cells.

    The company noted that data from the extension trial indicates that subjects previously treated with T-cell vaccine can be safely and effectively retreated with Tovaxin.

    The Tovaxin Phase IIb clinical study known as TERMS will include 150 patients and will evaluate the efficacy, safety and tolerability of the Tovaxin T- cell vaccination with clinically isolated syndrome and relapsing-remitting multiple sclerosis patients. Opexa completed patient enrollment in the 52-week TERMS study on May 17, 2007. All patients who complete the TERMS trial will be eligible to participate in an optional one-year extension study.

    With Opexa known for developing therapies to treat diseases such as diabetes and multiple sclerosis by using adult stem cells drawn from patients' own blood, reporting encouraging results from an early stage trial with its T cell vaccine, Tovaxin in multiple sclerosis, it remains to be seen if Tovaxin's early promise eventually translates to a marketable drug, as it still has a long way to go to reach the shelf of the medicine cabinet. In February 2007, the company reported encouraging results from a clinical trial, evaluating its T-cell vaccine in patients with rheumatoid arthritis.

    Source: Trading Markets.com © 2007 The Connors Group, Inc. (22/06/07)

    Opexa Presents Tovaxin Research at Federation of Clinical Immunology Societies Annual Meeting
    Opexa Therapeutics, Inc, a company involved in the development and commercialisation of cell therapies, made a poster presentation at the 2007 Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS) in San Diego June 7-11 at the Sheraton San Diego Hotel & Marina. The poster, entitled "Identifying New Immunodominant Myelin Peptides in Relapsing Remitting Multiple Sclerosis Patients" was presented on Sunday, June 10.

    The presentation covered laboratory and clinical data from the Company's proprietary T-cell vaccination technology for the treatment of multiple sclerosis. Key highlights of research detailed in the poster presentation include:

    -- Data accumulated from over 173 assays (using a T-cell Epitope Analysis Assay (EAA)) have allowed Opexa to identify several myelin protein peptides from myelin basic protein (MBP), myelin proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) as being immunodominant, including some peptides never before reported, and others as being non-reactive,

    -- The EAA can be utilised to screen additional or combinations of peptides that have biological significance and;

    -- These results have permitted Opexa to optimise the number of myelin peptides across the lengths of MBP, PLP and MOG in the screening assay for Tovaxin(TM) vaccine production to qualify subjects for Opexa's current 150-patient Phase IIb safety and efficacy clinical trial (TERMS).

    "These findings mark an important development for Tovaxin, which is a patient-specific autologous T-cell vaccine, because it helps us qualify subjects for our current clinical trial and improves production of the vaccine. The EAA is an important assay for further refinement of the T-cell vaccination technology, which is truly personalised, to make the therapy as efficacious as possible for each patient," said Jim Williams, PhD, chief operating officer.

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin(TM). The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

    About TERMS 

    The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    Source: Pharmalive © 2007 Engel Publishing Partners (12/06/07)

    Opexa Therapeutics Completes Patient Enrollment in Phase IIb Trial of Tovaxin™ for Treatment of Multiple Sclerosis
    Opexa Therapeutics, Inc., a company involved in the development and commercialisation of cell therapies, today announced the completion of patient enrollment in a 150-patient Phase IIb safety and efficacy study (TERMS). The trial design is a U.S. multicentre, randomised, double-blind, placebo-controlled study of subcutaneous Tovaxin™ in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS).

    Patients participating in the study, which is being conducted under Opexa’s U.S. Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA), will receive 52 weeks of treatment and will undergo safety and efficacy assessments using primary criterion of gadolinium-enhancing lesions and secondary criterion of annualised relapse rate. The Company will collect descriptive analysis data on the first 75 subjects to reach 6 months evaluable later this year. This trial was specifically designed, with the assistance of well-known multiple sclerosis experts, to address three important objectives: to rigorously assess the safety and efficacy of Tovaxin, to maintain a robust clinical effect for the full study, and to provide a scientific and clinical database for advancement to Phase III.

    David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "Full enrollment in this Phase IIb study is an important milestone in the commercialisation of Tovaxin. With this milestone achieved, we now look forward to reporting a descriptive analysis in the fourth quarter of 2007 and the full data results in the second half of 2008." McWilliams continued, "I am convinced that the ability to rapidly enroll this study across 35 U.S. centres reflects the high level of interest by multiple sclerosis patients in new safe and effective treatments."

    Edward Fox, MD, PhD and lead principal investigator for the Phase IIb study, commented, "If the results of this study can replicate the safety and effectiveness demonstrated in earlier studies, I believe Tovaxin could be an important advance in treating patients with MS. I’m pleased that the positive response from physicians and their MS patients across the country has resulted in the rapid enrollment of this study."

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin™. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

    About TERMS

    The Tovaxin Phase IIb clinical study will include 150 patients in a multicentre, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    Source: Business Wire © Business Wire 2007 (17/05/07)

    Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with Tovaxin(TM) for Multiple Sclerosis
    Opexa Therapeutics, Inc, a company involved in the development and commercialisation of cell therapies, today announced positive top-line data in an open-label Phase I/II dose escalation clinical trial of the investigational T-cell vaccine, Tovaxin(TM), for multiple sclerosis. In this one-year, 10-subject dose escalation clinical trial, Tovaxin therapy was shown to be safe and effective. The "per-protocol" analysis of Tovaxin therapy achieved a 90% reduction (p = 0.0039) in annualised relapse rate (ARR) in subjects who received one of the three dosage levels; the doses were 6 - 9 x 10(6), 30 - 45 x 10(6) or 60 - 90 x 10(6) attenuated T-cells. Subjects in the study received subcutaneous injections of Tovaxin over a period of 20 weeks (0, 4, 12 and 20 weeks) and were monitored for an additional 32 weeks.

    The safety profile for all dosage levels revealed no severe adverse reactions related to T-cell vaccination. With increasing dosage, an increase in mild injection site reactions was observed and these resolved within 48 hours.

    All subjects currently are enrolled in an extension study to collect longitudinal safety and effectiveness data.

    David McWilliams, president and chief executive officer of Opexa, commented, "We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 - 45 x 10(6) T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 - 45 x 10(6) T-cell dose."

    About TERMS

    The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T- cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate. As of March 19, 2007, Opexa reported that more than 110 patients have been enrolled in the TERMS clinical trial and the Company expects enrollment to be complete by mid 2007. All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    About T-cell Vaccination

    For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

    Source: Opexa Theraputics. (03/04/07)

    Opexa Achieves Midpoint in Patient Admissions in Phase IIb Trial of Tovaxin for Multiple Sclerosis
    Opexa Therapeutics, Inc. admitted the first 75 patients in its 150-patient Phase IIb clinical trial of Tovaxin in multiple sclerosis.

    Enrollment is expected to be completed by mid-2007. There are currently 34 trial sites in the US, all of which are actively recruiting patients.

    David McWilliams, president and chief executive officer of Opexa, commented, "Given the efficacy and safety demonstrated in our Phase I/II study of Tovaxin and the emerging understanding in the scientific literature of the involvement of pathogenic T-cells in multiple sclerosis, this trial has been highly anticipated in the MS community. We are excited about the enrollment interest we are receiving and feel comfortable that we will be able to achieve our 100% enrollment goal in the first half of this year."

    As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-cell vaccination with clinically isolated syndrome and relapsing-remitting MS patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks.

    The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    Source: NewsRx Copyright 2007, NewsRx.com.(04/03/07)

    Opexa Therapeutics Launches Tovaxin(TM) Clinical Trial Website for Multiple Sclerosis

    Opexa Therapeutics, Inc, a company involved in the development and commercialization of cell therapies, today announced that it has launched an information website for its Phase IIb study of Tovaxin(TM) ("TERMS" study) located at www.tovaxin.com The TERMS study is being conducted at 35 U.S. sites to evaluate the safety and effectiveness of the investigational T-cell vaccine, Tovaxin, for the treatment of multiple sclerosis. The site includes information for prospective trial participants and supplements the clinical trial registration information on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions.

    David McWilliams, president and chief executive officer of Opexa, commented, "Given the strong interest in our Tovaxin Phase IIb clinical trial, we felt compelled to create a website that provides information to prospective patients and their families. We look forward to using this site for future trials and into commercialisation."

    About TERMS

    The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    Source: Digital50 Copywrite American Digital Networks, All Rights Reserved 2000-2007(15/02/07)

    Opexa Achieves Midpoint in Patient Admissions in Phase IIb Trial of Tovaxin for Multiple Sclerosis
    Opexa Therapeutics, Inc. a company involved in the development and commercialisation of cell therapies, announced today that it has admitted the first 75 patients in its 150-patient Phase IIb clinical trial of Tovaxin(TM) in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 34 trial sites in the U.S., all of which are actively recruiting patients.

    David McWilliams, president and chief executive officer of Opexa, commented, "Given the efficacy and safety demonstrated in our Phase I/II study of Tovaxin and the emerging understanding in the scientific literature of the involvement of pathogenic T-cells in multiple sclerosis, this trial has been highly anticipated in the MS community. We are excited about the enrollment interest we are receiving and feel comfortable that we will be able to achieve our 100% enrollment goal in the first half of this year."

    Jim Williams, Ph.D., chief operating officer of Opexa, commented, "We are pleased to have reached this important milestone in our clinical program for the development of Tovaxin as a first line therapy for multiple sclerosis. The admission of 75 patients into the Phase IIb trial attests to the ability of Opexa to organise its clinical trials, including patient recruitment, site selection and manufacturing capacity as we meet the challenge of developing a patient-specific autologous T-cell vaccination therapy for multiple sclerosis."

    As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    Source: PharmaLive © 2007 Engel Publishing Partners(31/01/07)

    Opexa Begins Dosing Patients in Phase IIb Trial of Tovaxin(TM) for Multiple Sclerosis
    Opexa Therapeutics, Inc, a company involved in the development and commercialisation of cell therapies, announced today that it has dosed the first patient in its 150-patient Phase IIb clinical trial of Tovaxin(TM) in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 31 trial sites in the U.S., all of which are actively recruiting patients; the first patient was treated by Dr. Suzanne Gazda, Principal Investigator at Integra Clinical Research in San Antonio, Texas.

    As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks.

    The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    David McWilliams, president and chief executive officer of Opexa, commented, "We have received a very enthusiastic response regarding the prospects for Tovaxin within the multiple sclerosis community. The screening of patients is proceeding well, and we believe that due to Tovaxin's excellent safety profile, enrollment will be very attractive to patients and their physicians."

    Source: Opexa Therapeutics, Inc.(06/11/06)

    Opexa Commences Phase IIb Multiple Sclerosis Study
    Reports Positive Phase I/II Data.

    Opexa Therapeutics, Inc., a company involved in the development and commercialisation of cell therapies, today announced a number of positive steps in the Company's development including: Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun.

    More than 90 attendees from 35 clinical sites attended the investigators' meeting held recently in The Woodlands. These sites have begun screening patients for the 150-patient trial. Opexa expects that the first patients will be enrolled early in the fourth quarter of this year. Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

    Commenting on the Phase IIb study, Edward J. Fox, M.D., Ph. D., Clinical Assistant Professor, University of Texas Medical Branch, and director of the MS Clinic of Central Texas (Austin), the lead principal investigator for the Phase IIb study said, "The investigators at the kick-off meeting held in late August expressed a great deal of enthusiasm for this trial and were ready to begin screening patients. We are optimistic that this trial will advance our understanding of Tovaxin as a possible safe and effective treatment for Multiple Sclerosis."

    As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo.

    The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualised relapse rate.

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    David McWilliams, president and chief executive officer of Opexa said, "We are pleased to begin this trial and based on recent data from our Phase I/II studies, we believe that those early results support the rationale for moving forward. We now have 12-month data from our two earlier studies, which indicate that the patients treated had a greater than 90% annualised relapse rate reduction, as compared with their prior history."

    About Opexa Therapeutics

    Opexa Therapeutics develops and commercialises cell therapies to treat several major disease areas such as MS, rheumatoid arthritis, pancreatic and cardiac conditions. Opexa has exclusive license from Baylor College of Medicine for individualised cell therapies and has initiated a Phase IIb clinical trial to evaluate effectiveness in treating MS.

    Source: Opexa Therapeutics, Inc.(18/09/06)

    PharmaFrontiers to Present Data on Adult Human T-Cell Vaccination Technology at the Federation of Clinical Immunology Societies Annual Meeting
    PharmaFrontiers Corp, a company involved in the development and commercialization of cell therapies, announced today that the Company will make a poster presentation at the 2006 Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS) at the San Francisco Marriott on June 3, 2006.

    The presentation will cover laboratory and clinical data from the Company's proprietary T-cell vaccination technology for the treatment of the autoimmune disease, multiple sclerosis and is entitled:

    "Characterization and Clinical Response of a T-Cell Vaccination for Multiple Sclerosis."

    Multiple Sclerosis (MS), an inflammatory, demyelinating disorder of the human central nervous system (CNS) is the leading cause of nontraumatic neurological disability in young adults. The pathogenesis of MS involves antigen specific T cells directed against the protective myelin sheath of the neural network leading to a blocking of the transmission of nerve impulses. Over time exacerbations of the disease occur, leading to debilitating symptoms and eventually total disability.

    The Company has developed a novel technology that utilizes an autologous T-cell vaccine known as Tovaxin. Tovaxin is composed of Myelin Reactive T cell (MRTC) lines against the major proteins of the myelin sheath, myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG). A commercially feasible screening process has been developed to identify patient-specific myelin protein peptide reactive T cells from a patient's blood. The MRTC are expanded ex vivo, irradiated to render them non-replicating, and then administered subcutaneously to the patient as an individualized T-cell vaccine. This method allows the development of a patient-specific T-cell vaccine that induces an anti-idiotypic immune response directed against the T-cell receptor of patient-specific subsets of autoreactive T cells, thereby depleting these autoreactive cells in MS patients. The majority of vaccine T-cells are activated, as seen by CD25 (IL-2R) expression. This suggests that the T-cell vaccine also has the ability to elicit an anti-ergotypic response that may lead to a shift in the patient cytokine profiles.

    "We are pleased that two ongoing Phase I/II clinical trials have shown reductions in relapse rate and alleviation of MS symptoms. A Phase IIb clinical trial with the T-cell vaccination, Tovaxin, is planned for the second quarter of 2006," said David B. McWilliams, Chief Executive Officer, PharmaFrontiers Corp.

    Source: PharmaFrontiers Corp.(13/04/06)

    Multiple Sclerosis vaccine testing to start in US
    A US company is set to begin a trial of a vaccine which it claims halts the progress of multiple sclerosis. PharmaFrontiers is to test its tailor-made vaccine on 100 patients with MS, after a small-scale study showed promise, New Scientist reports.

    MS experts have welcomed the research but urged caution because other vaccines have not been successful.

    The degenerative disease attacks the nervous system and affects 2.5m people worldwide, of which 1% die each year. In MS, immune cells destroy the myelin sheath - a protective layer - that surrounds nerve fibres in the brain and spinal cord and enables them to transmit impulses.

    The vaccine being studied in the US contains inactive myelin-specific T cells - found in the immune system. To make it, a blood sample is taken from the patient and the cells are extracted. They are then multiplied in a lab, and treated with radiation before being re-injected into the patient. The body's immune system then recognises these modified T cells as being damaged and attacks them, priming the body's defence system in the same way a conventionally designed vaccine would, the researchers say.

    '92% success'

    Earlier trials have shown that, in some cases, all these cells are wiped out when they are re-injected. But the immune system also targets undamaged cells of the same kind - even though they are not damaged - because they have the same markers on their surfaces.

    In one trial of 15 patients, the vaccine reduced the rate of flare-ups by 92%.

    The new study will compare the progress of 100 vaccinated people who have the relapsing-remitting form of the disease with 50 who are untreated.

    David McMillan, of PharmaFrontiers, said if earlier results were replicated in this study, it might be possible to slow or even halt the progress of the condition. " If that's the case, the earlier we can do it after diagnosis, the better."

    The company claims the vaccine would only have to be given four times a year.

    But MS experts say much more evidence is needed before there could be confidence in this vaccine, compared to others which have been worked on.

    Richard Rudick of the Mellen Center for Multiple Sclerosis in Cleveland, Ohio, said: "None have worked so far. This one may, but we don't yet know."

    A spokesman for the UK's MS Society said: "This is interesting work, and we are pleased to see it taken forward in a larger study."

    Source: BBC Health Website Copyright BBC (15/03/06) 

    PharmaFrontiers Presented Preliminary Tovaxin Clinical Plans at Multiple Sclerosis Centers Meeting

    PharmaFrontiers Presented Preliminary Tovaxin Clinical Plans at Multiple Sclerosis Centers Meeting

    PharmaFrontiers Corp. a company involved in the development and commercialization of cell therapies, presented preliminary clinical development plans to prove the safety and efficacy of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis, on June 4 at the 19th Annual Meeting of the Centers of Multiple Sclerosis Centers in Orlando, Fla.

    Tovaxin(TM) is a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells.

    The preliminary clinical development plans for the commercialization of Tovaxin(TM) were presented by Jim C. Williams, Ph.D., Chief Operating Officer. The plan entails completing the two Phase I/II clinical studies and the initiation of a pivotal Phase IIb/III clinical study by the first quarter of 2006.

     "The positive interim analysis results of Tovaxin(TM) serve to accelerate the development of Tovaxin(TM) for the treatment of patients who are in the early stages of MS. Together with our clinical development partner, INC Research, Raleigh, NC we are confident that our planned Phase IIb/III clinical study will advance our understanding of this novel T cell therapeutic vaccine for MS," said David B. McWilliams, chief executive officer of PharmaFrontiers.

    Previous studies of T cell vaccination conducted by Jingwu Zhang, M.D., Ph.D., Director of Research, Baylor Multiple Sclerosis Center at The Methodist Hospital, and colleagues have shown that a monovalent (MBP selected MRTCs) formulation was safe and potentially beneficial in relapsing remitting and secondary progressive patients.

    "The promising results in various open-label clinical trials in approximately 375 MS patients around the world using either monovalent or trivalent formulations of various T cell vaccines coupled with the positive results for Tovaxin(TM) announced by PharmaFrontiers Corp should accelerate the initiation of Phase IIb/III controlled clinical trials to prove the safety and efficacy Tovaxin(TM) in patients in the early stages of MS," said Dr. Zhang.

    Edward J. Fox, M.D., Ph. D., the lead principal investigator for the upcoming clinical studies and the director of The MS Clinic of Central Texas (Round Rock), presented an overview of current disease modifying therapeutic strategies (DMS) for the treatment of MS. Various DMS were compared to the approach of using T cell vaccination as a promising cellular therapy that specifically targets the depletion of MRTCs. The manufacturing and formulation of Tovaxin(TM) is a novel approach for the development of autologous "patient-specific" therapy.

    "The MS autoimmune mechanisms and novel manufacturing strategy for Tovaxin(TM) leads one to the conclusion that patient-specific product development that targets the depletion of the so called 'pathogenic T cells' should provide benefit to MS patients," said Dr. Fox.

    Brian Loftus, M.D., principal investigator for the two current Phase I/II studies and director of Neurology Research and Diagnostic Clinic of Houston, presented an overview of the preliminary data from the dose escalation trial. The safety profile for the preliminary results of the dose escalation study using Tovaxin(TM) indicate that patient-specific T cell vaccination is safe and well tolerated.

    "In addition to a unique safety profile for an MS therapeutic, the effectiveness data to date point to the need to continue development of Tovaxin(TM) in controlled clinical trials. Furthermore, therapy that reduces peripheral blood MRTC levels in concert with improvements in disability scores Kurtzke Expanded Disability Status Scale (EDSS) as well as in disability neurological assessments Multiple Sclerosis Impact Scale (MSIS-29) may prove to be a highly effective therapeutic for patients in the early stages of MS," said Dr. Loftus.

    Source: BussinesWire.com(08/06/05)

    PharmaFrontiers Tovaxin(TM) Phase IIb Multiple Sclerosis Clinical Trial Protocol Accepted by FDA
    PharmaFrontiers Corp, a company involved in the development and commercialization of cell therapies, announced today that the protocol for its Phase IIb clinical trial of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis (MS), has been accepted by the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).
     
    "PharmaFrontiers is very excited to receive a 'green light' from the FDA for our Phase IIb clinical trial. Our earlier open-label Phase I/II clinical trials not only gave us the safety and tolerability data we sought, but we also observed a trend towards a reduction in annualized relapse rate (ARR) in excess of 90%, the lowering of the myelin-peptide reactive T cells (MRTCs) in patients blood and the improvement in patients' clinical measures," said David B. McWilliams, chief executive officer of PharmaFrontiers. "The Tovaxin clinical program continues to show promising results and we believe that the completion of this Phase IIb clinical trial will allow us to launch a Phase III pivotal trial."

    Tovaxin is a trivalent formulation of attenuated MRTCs, which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells. MRTCs are believed to play a critical role in the pathogenesis of MS. Because several myelin antigens are described as potential autoantigens for MS, depletion of MRTCs using a trivalent formulation may have enhanced therapeutic effects.

    This multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study is designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell therapy with clinically isolated syndrome (CIS) and early relapsing-remitting MS (RR-MS) patients. Additionally, the study of these patients will evaluate biomarkers of Tovaxin's efficacy and to evaluate the effect of Tovaxin on immune deviation and epitope spreading.

    "We believe that the protocol design will allow us to study the clinical effects of Tovaxin in a group of patients requiring a safe and effective therapy," said Edward J. Fox, M.D., Ph. D., director of The MS Clinic of Central Texas (Austin) and the lead principal investigator for the upcoming clinical studies. "During this two-arm, 52-week, parallel-group study, patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate. Of the 150 patients participating in the trial, 100 will receive Tovaxin and 50 will receive the placebo."

    All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. The open-label study is being planned under a different protocol that will be submitted to the FDA.

    "A patient-specific therapeutic vaccination strategy, Tovaxin T cell vaccine is formulated using the MS patient's own myelin peptide-specific activated T cell lines, which are harvested and attenuated on the day of vaccine administration," said Jim C. Williams, Ph.D., PharmaFrontiers chief operating officer. "The shelf-life of the final product is approximately three days."

    PharmaFrontiers will be conducting the Phase IIb with its clinical development partner, INC Research, Raleigh, NC.

    Source: PharmaFrontiers Corp.(31/10/05)

    PharmaFrontiers Announces Positive Interim Results of Two Phase I/II Clinical Trials for Multiple Sclerosis

    PharmaFrontiers Announces Positive Interim Results of Two Phase I/II Clinical Trials for Multiple Sclerosis

    PharmaFrontiers Corp., a company involved in the development and commercialization of cell therapies, announced that interim results of Tovaxin(TM) in two Multiple Sclerosis (MS) Phase I/II open-label studies indicated that it was safe and well tolerated, and patients showed positive responses. All patients enrolled in the studies had received prior standard of care therapy for MS and were in the relapsing remitting or secondary progressive stages of MS.

    Tovaxin(TM) is a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells.

    An interim analysis of a Phase I/II dose-escalation study of six evaluable patients, half of whom received a low dose (six to nine million MRTCs) and the other half received a mid dose (30-45 million MRTCs) during the six-month evaluable period, indicated that the Tovaxin(TM) therapy reduces peripheral blood MRTC levels in concert with improvements in disability scores Kurtzke Expanded Disability Status Scale (EDSS) as well as in disability neurological assessments for psychological scores Multiple Sclerosis 29 point Impact Scale (MSIS-29). The exacerbation rate over the previous two years for the patients was 1.18 per year. Only one treated patient reported an exacerbation during the six-month evaluable period in this study. All of the related adverse events were mild or moderate in severity.

    An interim analysis of a Phase I/II extension study of nine evaluable patients, who received two doses (30-45 million MRTCs) during the six-month evaluable period, indicated a mean percent reduction in MRTCs observed at three and six months for all three categories of MRTCs. A statistically significant percent (greater than minus 60%) reduction in PLP T cells was observed at three and six months. There was a percentage reduction (greater than or equal to minus 21%) in MBP and MOG T cells at three and six months. Percentage reductions in the EDSS and MSIS-29 physiological scores from baseline were observed at the three and six-month follow-up visits. The exacerbation rate over the previous two years for the patients was 0.85 per year. There were no exacerbations during the six-month evaluable period in this study. The most common adverse event was injection site pain, reported by four patients. Adverse events reported by two patients included muscle weakness, abnormal vision, anorexia, pharyngitis / nasopharyngitis, neuropathy and paresthesia. All of the related adverse events were mild or moderate in severity.

    "We are very encouraged by these preliminary MRTC levels, which demonstrated a dose response and large mean percentage reductions from baseline at follow-up visits during the six-month period," said David B. McWilliams, chief executive officer of PharmaFrontiers. "Accordingly, we plan on beginning our Phase IIb/III clinical trials by the end of 2005 or early 2006." The Company's preliminary results and clinical development plans will be discussed at a June 4 luncheon at the 19th Annual Meeting of the Consortium of Multiple Sclerosis Centers in Orlando, FL.

    "These data, combined with the strong safety profile of Tovaxin(TM), should be welcome news to all MS patients and their families, especially in light of disappointing product news of this past year," Mr. McWilliams added.

    About PharmaFrontiers Corporation

    PharmaFrontiers' strategy is to develop and commercialize cell therapies to treat several major disease areas such as cardiac and pancreatic conditions and Multiple Sclerosis. The company holds the exclusive worldwide license from the University of Chicago, through its prime contractor relationship with Argonne National Laboratory, for patents relating to the use of adult pluripotent stem cells derived from patients' own circulating blood. PharmaFrontiers also owns patented and proprietary individualized cell therapies that are in FDA Phase I/II human dose ranging clinical trials to evaluate their safety and effectiveness in treating MS.

     Source: PharmaFrontiers Corp.(03/06/05)

    PharmaFrontiers to Present Tovaxin(TM) Research at International Multiple Sclerosis Meeting

    PharmaFrontiers Corp. a company involved in the development and commercialization of cell therapies, announced today that their research of their Phase I/II clinical trials of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis, has been accepted for presentation at the 21st Congress of the European Committee/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis to be held September 28 - October 1, 2005, in Thessaloniki, Greece. The interim trial results have indicated that the treatment appears safe and well tolerated.

    Tovaxin(TM) is a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells.

    In addition to the safety and tolerance indications, the study concluded that MRTCs in patients with MS can be depleted by Tovaxin(TM) treatment. Multiple Sclerosis Impact Scale (MSIS) and Kurtzke Expanded Disability Status Scale (EDSS) clinical measures are improved.

    "Having the opportunity to present such encouraging data from Tovaxin(TM) clinical trials at such a prestigious international MS meeting is a great honor and very exciting for our researchers and all of the PharmaFrontiers staff. The acceptance of our abstract confirms our confidence as we move ahead with the development of Tovaxin(TM) for the treatment of patients who are in the early stages of MS," said David B. McWilliams, chief executive officer of PharmaFrontiers. "With our clinical development partner, INC Research, Raleigh, NC, we plan to initiate this pivotal Phase IIb/III clinical study of early relapsing MS patients by the first quarter of 2006 to advance our understanding of this novel T cell therapeutic vaccine for MS."

    Source: PharmaFrontiers Corp (10/08/05)

    © Multiple Sclerosis Resource Centre

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    NT-KO-003
    Ocrelizumab
    ONO-4641
    PEGylated interferon beta
    PI-2301
    Rebif®
    RPC1063
    RPI-78M
    RTL-1000
    Sativex®
    SHK
    Statins
    Trimesta (Oral Estriol)
    Tysabri®
    Zenapax (daclizumab)


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