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    You are here : Home » MS Research News » Drugs » Cyrevia


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    Plans unveiled for new MS drug study for Cyrevia

    CyreviaThe leading physicians from Accentia Biopharmaceuticals, Inc. and Johns Hopkins University have presented plans for a randomized clinical trial to study Cyrevia (formerly Revimmune) in multiple sclerosis (MS) to a number of key opinion leaders in the field and potential site investigators. Johns Hopkins University will serve as the lead trial site for the study.

    Physicians also co-hosted a meeting with prospective clinical trial investigators at the recent American Academy of Neurology (AAN) Annual Meeting in New Orleans.

    A group of invited key opinion leaders and neurologists from leading Multiple Sclerosis Centres of Excellence attended the Cyrevia investigators meeting, hearing presentations from two Johns Hopkins physicians: Douglas E Gladstone, MD, associate professor of Oncology, clinical director in-patient/out-patient programme (IPOP), Sidney Kimmel Comprehensive Cancer Centre; and Daniel M Harrison, MD, assistant professor of Neurology. Drs Gladstone and Harrison reviewed multiple open-label phase II Cyrevia studies conducted at Johns Hopkins, demonstrating significant benefit for Cyrevia versus historical outcomes in the treatment of a range of autoimmune diseases, and jointly proposed a controlled, randomized, multi-centre phase III MS study.

    “It was a great privilege to hear positive feedback from such an esteemed group of leading MS physicians, and we look forward to making a formal announcement as to the institutions that will participate in our planned Cyrevia clinical trial,” stated Samuel S Duffey, Esq., Accentia’s president and CEO. “In particular, we found tremendous enthusiasm for a single course of Cyrevia therapy administered over four consecutive days that offers patients the potential to 'reboot' their immune system in order to reduce their disability.”

    As a novel system of care to treat multiple sclerosis, Cyrevia (high-dose Cytoxan or “HiCy”) temporarily, but almost completely, eliminates circulating white blood cells, including autoimmune disease cells, while sparing the immune stem cells in the bone marrow. Following Cyrevia, the immune system reforms, only with new white blood cells derived from these stem cells, in effect “rebooting” itself and reestablishing an immune system without a large population of autoimmune cells. Cyrevia therapy includes a comprehensive risk management program (REMS) to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

    Source: Copyright © 2010 Saffron Media Pvt. Ltd (08/05/12)

    Multiple Sclerosis drug Revimmune receives FDA designation

    Revimmune LogoThe U.S. Food and Drug AdministrationbizWatch U.S. Food and Drug Administration granted Orphan Drug Designation to Revimmune, Accentia Biopharmaceuticals Inc.bizWatch Accentia Biopharmaceuticals Inc.'s planned therapy to treat autoimmune diseases including multiple sclerosis.

    With FDA Orphan Drug status, Accentia, based in Tampa, gains seven years of market exclusivity for Revimmune for systemic sclerosis and autoimmune hemolytic anemia upon its approval by the FDA, a company statement said.

    Last week, Accentia said it had entered into a definitive financing agreement for $4 million to support the development of Revimmune.

    Source: CheckOrphan Copyright © 2006-2010 CheckOrphan (28/06/11)

    Accentia biopharmaceuticals announces strategic agreement with Baxter

    MS MRIAccentia Biopharmaceuticals, Inc. today announced a strategic agreement with Baxter Healthcare Corporation to provide Accentia with the exclusive, worldwide right to purchase Baxter's cyclophosphamide, which is marketed under the brand name Cytoxan(R), for the treatment of designated autoimmune diseases including multiple sclerosis.

    Cyclophosphamide is the active drug used in Revimmune(TM) therapy, Accentia's proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases.

    The agreement also grants Accentia with the exclusive right for designated indications to reference Baxter's proprietary, historical data related to cyclophosphamide as part of Accentia's planned clinical and regulatory development of Revimmune. The agreement designates Baxter as Accentia's sole source of cyclophosphamide for Revimmune.

    "We are pleased that, through this agreement, we will be able to support Accentia Biopharmaceuticals in the ongoing development of Revimmune," said Debasis Chakrabarti, M.D., Ph.D., Baxter's Therapeutic Area Leader for Oncology. "Further investigation of cyclophosphamide may identify a potentially valuable treatment option for patients with devastating autoimmune diseases, including multiple sclerosis, with high unmet medical need."

    According to Accentia's President, Mr. Samuel S. Duffey, "We consider our agreement with Baxter to be highly strategic to Accentia's plans for the development and commercialization of Revimmune. We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to reference Baxter's data related to cyclophosphamide not only assures that Accentia will have access to the highest quality supply of cyclophosphamide, but also facilitates Accentia's regulatory strategy and reinforces its market position. With this agreement in place, we are planning a robust clinical and regulatory development strategy to advance our mission to establish Revimmune as a new standard-of-care treatment for patients suffering from autoimmune diseases, including orphan indications with potential accelerated regulatory pathways, as well as major indications such as multiple sclerosis."

    Source: Business Wire Copyright Business Wire 2010 (29/11/10)

    Possible stop to Multiple Sclerosis could be just one trial away, however, pharmaceutical companies not interested

    MS MRIA Utah woman is about to begin a medical journey that she hopes will save her life. Michelle Colledge has Multiple Sclerosis, a disease that causes paralysis, blindness, and sometimes death.   Johns Hopkins is testing a new treatment for this debilitating disease that so far, is dramatically effective. Michelle Colledge has been accepted as part of the study of this new and very aggressive treatment.

    Michelle was diagnosed on Valentines Day 2007. She says, “The only way to describe those first couple of months was absolute terror, and crying at night for several hours, and just thinking my life was over.”  The young mother developed lesions on her brain and spine, her own immune system, charged with protecting her, had turned against her and become the enemy. Dr. Adam Kaplin, M.D. from Johns Hopkins explains; “What these people have, are these periods of time where their brains, spinal cords and their optic nerves are under attack .”  He says no one knows why it happens, but doctors believe the immune system is tricked in reaction exposure to bacteria, viruses, or even a vitamin D deficiency.

    Michelle can’t pinpoint a trigger for her MS, but she says each attack takes away the ability to live a normal life. “When I say attacks, I am not talking about, oh, I woke up and I wasn’t feeling well. I lost something. I would stop being able to walk, or I would lose my eyesight.” She has regained those abilities, but the MS has taken its toll on her balance, she has lost feeling in her hands, and they shake, making it difficult to hold objects, or her own daughter. “My daughter is four years old and I don’t know if she will ever know who her mom is. She may just see what the disease has left behind.”

    But because Michelle’s MS is progressing so rapidly, there is new hope. She has been selected for a clinical trial of HiCy-Copaxone that could dramatically change her life, and the lives of everyone battling Multiple Sclerosis. Johns Hopkins has found a way to erase a faulty immune system. Dr. Kaplin says it’s a little like what you do to a computer. “It resets the immune system. We think of it as kind of the control, alt, delete of the immune system.”

    Michelle will undergo intense chemotherapy using a strong drug developed decades ago (HiCy). Dr. Kaplin says “We use it at 14 thousand milligrams, in one treatment, over the course of four days.” And when it’s over Michelle’s old immune system will be gone, and so will her MS. “You watch the patients white blood cell count go to zero, and then something amazing happens, which is their cells start to repopulate and eventually the white blood cells come back to normal.”

    Patients are given an additional medication, Copaxone, that along with the chemo, puts them into long term remission. So far, out of 40 patients who have participated in the study, 90 percent have shown no signs of the disease one to three years after their treatment.  For some, the symptoms of MS have also disappeared. “We had one individual who needed a walker to get around and he now runs five miles every morning.”

    Michelle is nervous to begin the journey to living MS free, but she’s excited about what it will mean to her and her family, as well as others who battle the disease. “This is a chance for  me and it should not stop with me.”

    Unfortunately, it could. Michelle believes she is the last patient accepted into the second of Johns Hopkins clinical trials, and it may be the last. Dr. Kaplin says that although the first two trials were exceedingly promising, and no side effects were reported, outside of the usual reactions associated with Chemotherapy, there may be no more opportunity to test what could prove to be the cure for MS and other autoimmune disorders. “We need to do a randomized clinical trial, a much larger trial ,between 150 and 300 patients. It’s a very expensive process. We need 15 million dollars to get this done.” 

    Without the trial, there can be no FDA approval, and insurance companies will not cover the cost of the treatment. “We have gone to three different pharmaceutical companies and we have showed them the data, and asked them if they would be willing to get involved in this. We’ve had the same response from all of them. They all said it’s an amazing treatment, we have seen nothing like it, this might one day lead to a cure for MS, if we could refine it.  They say its fabulous, but we don’t think we could recoup our investment, so it’s not for us.”

    The problem Dr. Kaplin explains, is the drugs used in combination in this new treatment are decades old, cheap, and the patents have expired. This means, it is difficult for pharmaceutical companies to make a profit.

    Johns Hopkins has started a grass roots campaign to try to raise the money. 

     Source: ABC 4 News Copyright 2009 Newport Television LLC & MSRC (16/11/09)

    Revimmune® Shows Unprecedented Results in Reducing Disability and Improving Functions in Multiple Sclerosis

    Accentia Biopharmaceuticals, Inc. announced that researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune(TM), Accentia's patent-pending, novel usage of an approved chemotherapeutic drug (cyclophosphamide) in an ultra-high dose (HiCy), pulsed intravenous administration for four hours daily over four days. Administered in this fashion, cyclophosphamide acts as a unique stem-cell sparing myeloablative which can reboot the immune system in order to delete the autoimmunity. Furthermore, Revimmune is believed to be the first therapy in development for multiple sclerosis that proposes the restoration of neurological function with the potential to eliminate the autoimmunity.

    The article titled "Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis" was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient's functional status.

    One of the study's authors, Dr. Douglas Kerr of Johns Hopkins University, said, "I believe our preliminary results in treating MS with Revimmune are unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up. We look forward to working closely with Accentia's team to advance Revimmune into a definitive phase 3 clinical trial, initially for refractory MS, but ultimately targeting a host of other autoimmune diseases as well."

    Revimmune therapy consists of an ultra-high intensity, short-course, intravenous formulation of cyclophosphamide. It is believed that Revimmune "reboots" a patient's immune system, thereby typically eliminating the autoimmunity. The "rebooting" process is achieved because Revimmune eliminates the cells causing the autoimmunity and spares the stem cells in the bone marrow. These surviving stem cells are then able to repopulate a restored, uncompromised immune system.

    Accentia has filed a pre-IND submission with the FDA for the commencement of a Phase 3 trial, and the Company is preparing to file an IND later this year. Based on initial discussions with the FDA, the Company anticipates that the primary endpoint for this planned study will be the recovery of lost functions in multiple sclerosis patients.

    Source: Accentia Biopharmaceuticals, Inc. (18/06/08)

    Revimmune Receives the Frost & Sullivan Multiple Sclerosis Product Innovation of the Year Award
    Accentia Biopharmaceuticals, Inc. today announced that Revimmune, its potential blockbuster therapeutic candidate designed to treat up to 80 autoimmune diseases, has been awarded the Frost & Sullivan 2007 North American Multiple Sclerosis Product Innovation of the Year Award. If approved, Revimmune would be the first product capable of restoring neurological function in patients with relapsing-remitting multiple sclerosis (MS). Accentia intends to file an Investigational New Drug Application (IND), aiming to commence a Phase 3 MS clinical trial this year.

    The selection of the Frost & Sullivan Award comes through in-depth interviews and primary market analysis conducted by their industry analyst team. Nominations or submissions for Frost & Sullivan Awards are not accepted.

    Frost & Sullivan Analyst, Barath Shankar Subramanian, stated, The primary endpoint for Accentias planned Revimmune Phase 3 study is the restoration of neurological function, which is a paradigm shift from traditional therapies that focus on reducing relapses. Accentias innovative positioning and approach to treating autoimmune disease is likely to propel the company as a strong participant in the MS market. In recognition of these factors, Frost & Sullivan is pleased to present Accentia with this Award.

    According to Barath Shankar, the mechanism of action of Revimmune is highly innovative, focusing on eliminating the peripheral immune cells, which include the cells that are causing MS. The therapy selectively spares the hematopoetic stem cells, which then regenerate as a new immune system in two to three weeks that lacks the previous autoimmunity. This could potentially improve neurological function and eliminate the disease.

    Revimmune could also potentially alter the high cost of therapy for patients. For those patients utilizing traditional therapies, they incur a lifetime of treatment costs, while with Revimmune there is just a one time cost of the treatment regimen. Additionally, Revimmune has the potential to emerge as an effective treatment for several other autoimmune disorders, giving Accentia the potential of addressing a significantly larger patient population that lacks significant therapies.

    Accentia holds the worldwide, exclusive license to Revimmune for the treatment of autoimmune diseases, and the Company intends to file an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune for the treatment of refractory, relapsing-remitting multiple sclerosis.

    Source: Business Wire ©2008 Business Wire (13/03/08)

    Accentia Announces Investigational New Drug Application for Revimmune Usage in a Pivotal Phase 3 Study of Refractory Multiple Sclerosis
    Revolutionary Treatment for Multiple Sclerosis Intended to Eliminate Autoimmunity and Restore Lost Function.

    Accentia Biopharmaceuticals announces that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune(TM). The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune, the company's potential therapeutic for refractory, relapsing-remitting Multiple Sclerosis (MS). The FDA indicated that they support the proposed submission from Accentia and that they are in overall agreement with the proposed design of the Accentia clinical program.

    The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune.

    Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to "reboot" a patient's immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.

    Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

    Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

    The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.

    Source: Accentia Biopharmaceuticals, Inc. (09/10/07)

    Accentia files preliminary IND for MS drug
    Accentia Biopharmaceuticals has filed a preliminary Investigational New Drug application with the FDA for Revimmune in the treatment of refractory multiple sclerosis.

    The company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase III clinical trial involving approximately 270 patients with relapsing/remitting multiple sclerosis (MS) with a primary endpoint of improvement in function (reversal of disability).

    Based on a clinical study at the Johns Hopkins University School of Medicine, which showed an unprecedented 42% average improvement in function, Accentia believes that Revimmune holds the potential to restore function in many patients who have acute deficits due to MS.

    In addition, the company believes that the long-term follow-up with patients in the proposed 48-week trial will demonstrate that Revimmune induces not only a reduction of the risk of exacerbations, but potentially also long-lasting remissions and possibly cures in MS patients.

     Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks.

    The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

    Source: Pharmaceutial Business Review ©2007 Business Review (01/08/07) 

    Accentia gets new financing, moves into MS drug market
    Accentia Biopharmaceuticals Inc. said it has acquired the rights to a treatment in the late stages of development that is designed to help people with autoimmune diseases, including multiple sclerosis.

    The deal calls for Accentia to pay royalties and issue stock warrants once the treatment is approved in the United States, according to a Feb. 28 filing with the Securities and Exchange Commission.

    Tampa-based Accentia also said it raised about $20 million in cash through a new financing agreement with several institutional investors. The cash raised by issuing convertible debentures will be used to continue the company's strategy of acquiring late-stage drug candidates as well as for supporting ongoing clinical development programs, the company said in a separate SEC filing.

    Immune system 'reboot'

    The patent-pending treatment to which Accentia has acquired exclusive world-wide rights, Revimmune, uses an approved drug, cyclophosphamide, in a new patent-pending method to "reboot" a patient's immune system, eliminating the autoimmunity, according to a release. Current therapies including oral cyclophosphamide are used to try to suppress the inflammation of autoimmunity, the release said.

    Accentia's agreement for the rights to Revimmune covers all of the estimated 80 autoimmune diseases that are currently recognised, but Accentia said its lead indication for the treatment is multiple sclerosis.

    The technology was developed at John Hopkins University and initially licensed to Revimmune LLC. Revimmune is a portfolio company of Hopkins Capital Group II LLC.

    Milestone payment

    Accentia, is managing partner of Hopkins Capital Group.

    Accentia sublicensed the technology from Revimmune, the SEC filing said. Accentia will pay Revimmune a royalty of 4 percent on net sales and issue vested warrants to purchase 800,000 shares of Accentia stock at an exercise price of $8 a share. Accentia also will make a milestone payment of up to $50,000 at the issuance of the first patent and $100,000 at the first FDA product approval, the filing said.

    Acquiring the rights to Revimmune is in keeping with Accentia's strategy of developing late-stage clinical products based on already approved pharmaceuticals, O'Donnell said in the release. It's a similar tack Accentia took for its lead product, SinuNase, designed for people with chronic sinusitis, which is in Phase 3 clinical trials.

    Source: Tampa Bay Business Journal © 2006 American City Business Journals, Inc (28/02/07)

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