MBP8298

Eli Lilly and Co and BioMS Medical Corp said their experimental treatment for multiple sclerosis, MBP8298, failed to delay progression of the disease in a late-stage trial and that they would discontinue all ongoing studies of the product.

The death knell for BioMS' main product comes six months after the drug, called dirucotide, failed to meet a main goal in a mid-stage study, sending the tiny company's shares down more than 50 percent.

In the earlier study, the drug failed to prevent symptoms of the potentially crippling neurologic condition from returning among patients with the relapsing-remitting type of the disease. Such patients have unpredictable relapses followed by months to years of remission.

The drugmakers, which have been collaborating since late 2008 on dirucotide, said the latest negative results were seen in a study of the drug that involved 612 patients with secondary progressive multiple sclerosis (SPMS). Such patients have initial relapsing-remitting MS, but then begin to have progressive neurologic decline between acute attacks without definite periods of remission.

Patients in the study were divided into groups that received either dirucotide or a placebo intravenously every six months for two years.

In addition to failing its primary goal of delaying the time it took for the disease to worsen in patients, the drug also failed secondary goals, the drugmakers said.

"We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data," BioMS Medical Chief Executive Kevin Giese said in a statement.

The deal between the two drugmakers gave Lilly worldwide rights to dirucotide and BioMS an upfront payment of $87 million. In addition, BioMS was given the right to potential milestone payments of up to $410 million and escalating royalties on sales if the drug was approved.

Indianapolis, Indiana-based Lilly, which badly needs new drugs as it girds for the looming patent expiration of its Plavix blood clot preventer, has been responsible for research and development of the drug

Source: Reuters © Thomson Reuters 2009 (28/07/09)

BioMS Medical Corp. announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase III MAESTRO-01 Canadian/European trial of dirucotide in patients with secondary progressive MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the final scheduled review by the DSMB prior to the completion of MAESTRO-01. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. Results from MAESTRO-01 are expected in the second half of this year.

About MAESTRO-01

MAESTRO-01 is a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide in patients with secondary progressive MS. The study is being conducted at 47 sites across Canada and nine countries in Europe and includes 611 patients being administered either dirucotide or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease, as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 70% of all MS patients are HLA-DR2 and/or HLA-DR4 positive). Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

Source: BioMS Medical Corp. (22/04/09)

BioMS shares jumped more than 12 percent on Tuesday after an independent safety drug board recommended the biotech company continue trials of its multiple sclerosis treatment.

The company said the U.S. Data Safety Monitoring Board completed a safety analysis of its phase 3 Maestro-03 trial of dirucotide, used for the treatment of secondary progressive MS, (SPMS) and ruled that the company should continue.

SPMS is characterised by a steady progression of clinical neurological damage, with or without superimposed relapses and minor remissions.

Dirucotide is being studied in two late-stage trials -- in the United States and across Europe and Canada -- as a treatment for SPMS. Key results are due later this year.

"We believe the Data Safety Monitoring Board's decision today to continue the trial bodes well for the safety of the drug, but in our view does not impact the potential efficacy results coming out, which we continue to believe to be risky, but if it works could be a major positive catalyst for the stock," said Maher Yaghi, an analyst at Desjardins Securities in Montreal.

Yaghi said positive results could propel the company's stock to as high as C$15 a share.

BioMS shares tumbled more than 50 percent in late January after studies showed the treatment failed to meet a main goal in a mid-stage study.

The study, when used by patients suffering from relapsing-remitting multiple sclerosis (RRMS) showed the drug did not prevent symptoms from coming back. People who took the drug were just as likely to have symptoms return after 15 months as patients who did not take it.

The drug, did, however, show signs of slowing down the progression of the crippling disease.

Source: Reuters.com © Thomson Reuters 2009 (14/04/09)

BioMS Medical Corp. announced that the MINDSET-01 study, an exploratory phase II clinical trial evaluating dirucotide in patients with relapsing-remitting multiple Sclerosis or MS failed to meet primary endpoints, annualized relapse rate or associated secondary MRI endpoints.

Further, the company said Dirucotide did meet mean change from baseline in the Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite score.

Dirucotide has been evaluated in two ongoing phase III trials in the United States, Canada and Europe. Dirucotide was generally well tolerated and recorded common side effects were redness and burning sensation at the injection site.

Source: RTTNews © 2009 RTTNews (30/01/09).

BioMS Medical Corp. announced that the independent Data Safety Monitoring Board (DSMB) for the Company's U.S. pivotal phase III MAESTRO-03 trial of dirucotide (MBP8298) in patients with secondary progressive MS has completed the latest safety analysis and recommended that the trial continue as per the protocol.

Source: BioMS Medical Corp. (06/10/08)

BioMS Medical Corp. announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

Fast track designation is an FDA status reserved for products that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for that condition. Fast track designation can potentially facilitate development and expedite the review process.

"Our receipt of fast track designation for dirucotide in the U.S. is a significant milestone for both BioMS Medical and the MS community," said Kevin Giese, President and CEO of BioMS Medical. "Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options."

Source: BioMS Medical Corp. (04/09/08)

BioMS Medical Corp, says drug giant Eli Lilly and Co. has agreed to give it $10 million towards one of its trials after an independent drug safety board gave it the go-ahead.

The Edmonton-based company said that the Drug Safety Monitoring Board has done its testing of the so-called Maestro-01 trial "and has recommended that the trial continue to completion."

The trial is for a treatment for patients with secondary progressive MS.

"Based on the decision, Eli Lilly and Co. has agreed to provide the $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement," BioMS said Wednesday.

Kevin Giese, president and CEO of BioMS, said the announcement is "an important milestone" for the company.

"It moves us one step closer to our goal of bringing this important therapy to multiple sclerosis patients."

Source: Canada East © 2008 CanadaEast Interactive, Brunswick News Inc (14/08/08)

BioMS Medical Corp. announced that it has completed patient recruitment in its phase III clinical trial of MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately 510 patients, and is being conducted at 68 trial sites in the U.S.

"We have had great success in recruiting patients into the trial, which is a testament to the promise of our approach and the efforts of our investigators," said Mr. Kevin Giese, President and CEO. "Since initiating this trial in June 2007 we have been delighted by the enthusiasm of the patients and clinical groups participating across the U.S."

MBP8298 (dirucotide) is currently being developed in three late-stage clinical trials:

1. MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe.

2. MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States.

3. MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.

About MAESTRO-03

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either MBP8298 (dirucotide) or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

About MBP8298 (dirucotide)

MBP8298 (dirucotide) is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). MBP8298 (dirucotide) is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of MBP8298 is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

The apparent mechanism of action of MBP8298 (dirucotide) is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide delivered periodically by the intravenous route. The potential benefit of MBP8298 (dirucotide) for any individual patient is therefore expected to be related to the role this peptide plays in that patient's immune system. The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells.

The results of phase II and long-term follow-up treatment of MS patients with MBP8298 (dirucotide), published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 (dirucotide) safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4. Thus, MBP8298 (dirucotide) has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules.

Source: BioMS Medical Corp. (01/08/08)

BioMS Medical Corp. announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 (dirucotide) in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the fifth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial

The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 (dirucotide) in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 (dirucotide) versus placebo as measured by relapse rate, MRI activity and disease progression.

Source: BioMS Medical Corp. (17/07/08)

BioMS Medical Corp. announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 (dirucotide) in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the fourth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial

The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 (dirucotide) in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 (dirucotide) versus placebo as measured by relapse rate, MRI activity and disease progression.

Source: BioMS Medical Corp. (27/05/08)

BioMS Medical Corp. announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company's on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.

This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

To date, more than 65% of the total number of required patients have been enrolled in the Company's MAESTRO-03 clinical trial, with full enrollment anticipated for the end of the first half of 2008.

Source: BioMS Medical Corp. (15/04/08)

BioMS Medical Corp. today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the third of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial

The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

Source: BioMS Medical Corp. (03/03/08)

The US Federal Trade Commission has cleared the global licensing and development agreement that grants Eli Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis compound, MBP8298. This represents a major step forward for Lilly, as the company looks to diversify its traditionally psychiatry-focused CNS offerings by expanding into neurology.

In December 2007, Lilly and BioMS entered into a global licensing and development agreement granting Lilly exclusive worldwide rights to the company's lead multiple sclerosis (MS) compound, MBP8298. The synthetic peptide compound consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein (MBP).

MBP8298 is currently being evaluated in two pivotal Phase III clinical trials in secondary progressive MS (SPMS) and one Phase II trial in relapsing-remitting MS (RRMS). BioMS will continue to oversee all current clinical trials, while Lilly will be responsible for all future R&D, manufacturing and marketing activities.

MBP8298 offers Lilly an ideal entry point into neurology. Estimated to be worth $5.2 billion across the seven major markets (7MM) - US, Japan, France, Germany, Italy, Spain and the UK - in 2007, the MS market has shown consistently strong annual growth, and is estimated to be the largest neurology indication by value. Additionally, with only Bayer Schering's Betaseron (interferon-beta 1b) and Merck Serono's Novantrone (mitoxantrone) approved for SPMS, this segment of the MS market represents an underserved and yet potentially high-value niche.

Lilly's psychiatry portfolio is coming to the end of its lifecycle, and the acquisition of MBP8298 represents its focus on investing in its future CNS offering ahead of the patent expiry of its antidepressant Cymbalta (duloxetine) in 2013. Lilly will be able to utilize its well-established expertise in the psychiatry sector, to help MBP8298 realize its full potential within the neurology arena.

Datamonitor anticipates the launch of MBP8298 for SPMS in the EU in H1 2011 and H1 2012 in the US. With the additional approval for RRMS expected by the end of 2013, Datamonitor expects the dosing of once every six months to be highly favorable among a significant number of patients, and by 2016 7MM sales are forecast to be in excess of $450 million.

Source: Pharamceutical Business Review ©2008 Business Review Ltd (29/01/08)

Under the terms of the agreement, Lilly and BioMS Medical will collaborate on the development of MBP8298 and will also share in certain development costs with Lilly being responsible for future R&D, manufacturing and marketing activities. BioMS Medical will receive an upfront payment of $87 million, as well as potential development and sales milestones up to $410 million and escalating royalties on sales commensurate with the current stage of development of the product if MBP8298 is successfully commercialized. BioMS Medical will continue to oversee the current clinical trials. Other terms of the deal were not disclosed.

"Lilly is pleased to add yet another promising late-stage compound to our portfolio," said Dr. William W. Chin, M.D., vice president of discovery research and clinical investigation for Lilly. "Multiple sclerosis is a disease with significant unmet patient needs. MBP8298 has shown potential in slowing the progression of secondary progressive MS, and thus may provide an effective therapeutic option for patients with this debilitating disease. We are also hopeful that MBP8298 may prove beneficial in treating patients with relapsing remitting MS. We intend to fully leverage our expertise in neuroscience to continue the development of this novel molecule."

"We are very pleased to collaborate with Lilly on the worldwide development of MBP8298," said Kevin Giese, President and CEO at BioMS Medical. "Lilly's well established leadership in the neurology arena and considerable resources, expertise and proven ability to launch first-in-class drugs will help MBP8298 to realize its full development and commercial potential."

About MBP8298

MBP8298 is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). MBP8298 is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of MBP8298 is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

The apparent mechanism of action of MBP8298 is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide delivered periodically by the intravenous route. The potential benefit of MBP8298 for any individual patient is therefore expected to be related to the role this peptide plays in that patient's immune system. The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells.

The results of phase II and long-term follow-up treatment of MS patients with MBP8298, published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4. Thus, MBP8298 has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules.

MBP8298 is being developed in three late-stage clinical trials: 

• MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe. 
• MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States. 
• MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.

Source: BioMS Medical Corp. (18/12/07)

This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

About MAESTRO-03
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

Recently the Company announced that more than 133 patients have been enrolled in its MAESTRO-03 trial. An interim safety and efficacy analysis will be performed on data from the first 133 patients enrolled when they have completed 24 months of the clinical trial.

Source: BioMS Medical Corp (12/12/07)

"There has been overwhelming enthusiasm and support from the MS community for our U.S. Phase III trial," said Kevin Giese, President and CEO of BioMS Medical. "With the ramp-up in the initiation of participating clinical sites and patient recruitment we are on track to complete enrollment in the first half of 2008."

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

Source: BioMS Medical Corp (12/11/07)

This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

Source: BioMS Medical Corp (09/11/07)

BioMS Medical Corp. today announced that interim safety observations from MAESTRO-01, the Company's on-going phase III trial of MBP8298 for the treatment of secondary progressive MS, were reported in a poster presentation at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

A second poster presentation reported the percentage of patients screened for the trial that had the target HLA-DR2/DR4 immune response genes.

ECTRIMS is one of the largest and most prestigious annual MS conferences, bringing together MS experts and thought leaders from around the world to discuss the latest MS research findings.

The first poster, entitled "Safety observations from administration of MBP8298 as part of the ongoing phase III MAESTRO-01 secondary progressive MS clinical trial", showed that MBP8298 administration resulted in no significant safety concerns measured over the current course of the MAESTRO-01 study.

The second poster, entitled "Haplotype analysis of Secondary Progressive Patients participating in the MAESTRO-01 Study", showed that overall, amongst the 10 countries enrolling patients in the MAESTRO-01 trial, (Canada, United Kingdom, Finland, Denmark, Sweden, Estonia, Latvia, Spain, Germany and the Netherlands) 70.38% of the 788 screened patients were observed to have HLA-DR2 and/or HLA-DR4 immune response genes.

"The first poster presentation demonstrates that the safety profile of our drug continues to look strong in a large multinational clinical trial setting," said Kevin Giese, President and CEO of BioMS. "The second poster reaffirms that MS patients with HLA-DR2/DR4 immune response genes, potentially account for more than 70% of the overall MS population in Europe and Canada."

Source: BioMS Medical Corp. (15/10/07)

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial

The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with approximately 215 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

Source: Pharmalive © 2007 Engel Publishing Partners (24/07/07)

"This is an important milestone in our strategy to commercialise MBP8298 on a global basis," said Kevin Giese, President and CEO of BioMS Medical. "The U.S. represents nearly half of the MS market and a successful outcome to this trial would put BioMS in a strong position to capture a significant portion of this and other major MS markets."

The primary clinical endpoint for the MAESTRO-03 trial is defined as a statistically significant time to disease progression as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive.

MBP8298 is being assessed in two additional ongoing trials:

• MAESTRO-01 is a pivotal phase III trial being conducted in Canada and Western Europe evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study and is fully recruited with 611 patients.
• MINDSET-01 is a phase II trial evaluating MBP8298 for the treatment of relapsing-remitting multiple sclerosis (RRMS). The trial is a randomised, double-blind study and is fully recruited with approximately 215 patients.

Source: BioMS Medical Corp (06/06/07)

"Reaching full recruitment in our relapsing-remitting MS trial in less than six months after initiating enrollment reflects the drive and dedication of our clinical team and all those involved in this trial," said Kevin Giese, President and CEO of BioMS Medical. "While there are current approved therapies for the relapsing-remitting form of MS, there is still a great need for treatments that are more convenient, safe and effective in treating the disease. MBP8298 has the potential to benefit patients with all forms of MS and with the long-term safety data it has generated to date, we believe MBP8298 would be greatly received."

MINDSET-01 Trial

The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial will be followed by a 12 month active treatment open label extension period. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

About MBP8298 - Novel Mechanism of Action

In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise "tolerant" of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.

MBP8298 is being developed in three late-stage clinical trials:

• MAESTRO-01: A pivotal phase III trial in Canada and Western Europe evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study with 611 recruited patients.
• MAESTRO-03: A pivotal phase III U.S. trial evaluating MBP8298 for the treatment of SPMS. The trial is a randomised, double-blind study enrolling approximately 510 patients.
• MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of relapsing-remitting multiple sclerosis. The trial is a randomised, double-blind study of approximately 215 patients.

Source: BioMS Medical Corp.(03/05/07)

Dr. Markowitz is Director of the Multiple Sclerosis Center at the Hospital of the University of Pennsylvania in Philadelphia. He is an Assistant Professor of Neurology at the University of Pennsylvania School of Medicine and an attending neurologist at the Hospital of the University of Pennsylvania.

"With few approved therapies for secondary progressive MS, this trial is important for the MS community and patients," said Dr. Markowitz. "I am pleased to play a key role in assessing the impact that MBP8298 may have on delaying disease progression of secondary progressive MS."

Dr. Markowitz is a member of the American Academy of Neurology and the International MS Forum. Dr. Markowitz is also Chairman of the clinical advisory committee for the Delaware Valley chapter of the National Multiple Sclerosis Society and a member of the Penn Neuro Care, MS section of the National Multiple Sclerosis Society. Dr. Markowitz is the author and co-author of a number of publications in the field of MS, and he serves as an ad hoc reviewer for Multiple Sclerosis, Journal of Clinical Immunology, Neuro-Rehabilitation and Neural Repair, and The Consultant.

BioMS Medical recently received clearance from the United States Food and Drug Administration (FDA) for the initiation of a pivotal phase III clinical trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive MS.

The pivotal phase III clinical trial in the US, named MAESTRO-03, will be a randomised, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

Source: BioMS Medical Corp.(20/04/07)

This interim analysis was based upon an assessment of the first 100 patients enrolled in the 550 patient study who had completed twelve months of treatment. In-depth safety data, including extensive MRI scans, were collected for this patient group and reviewed by the DSMB.

"Multiple sclerosis patients currently lack a safe and effective treatment to slow or halt disease progression," said Kevin Giese, President and CEO of BioMS Medical. "This positive recommendation represents important progress toward the completion of our pivotal study, and provides us with further confidence in MBP8298's safety profile and its prospects of achieving clinical success."

This is the first of two planned interim analysis in respect of MAESTRO-01. The next interim analysis will look at both safety and efficacy in the first 200 patients who have completed 24 months of the clinical trial, and is targeted for mid-2008.

Source: BioMS Medical Corp.(07/04/07)

Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.

"Now that the first patients who participated in our MAESTRO-01 pivotal trial have completed the study, we are pleased to offer MBP8298 on an open-label basis," said Kevin Giese, President and CEO of BioMS Medical. "We believe MBP8298 has the potential to become the only safe and effective first line therapy for the treatment of secondary progressive MS. While MAESTRO-01 was designed to evaluate the safety and efficacy of MBP8298, MAESTRO-02 will provide additional important long-term safety and efficacy data to support regulatory submissions."

About late-stage clinical trials for MBP8298:

BioMS recently announced that patient recruitment has been completed in the MAESTRO-01 trial. This trial includes approximately 550 patients at 48 trial sites in 10 countries. The Company remains on track to receive interim data in mid-2008.

Patients are being administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

MBP8298 is being studied in two additional late-stage clinical trials:

• MAESTRO-03: A pivotal phase III U.S. trial of similar design to MAESTRO-01, evaluating MBP8298 for the treatment of secondary progressive MS. The trial is a randomised, double-blind study enrolling approximately 510 patients that will be initiated in 2007.
• MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of relapsing remitting multiple sclerosis (RRMS). The trial is a randomised, double-blind study enrolling up to 215 patients.

Source: BIOMS MEDICAL CORP.(27/02/07)

"We are pleased to have reached this major milestone in this very important study," said Kevin Giese, President and CEO of BioMS Medical. "It brings us one step closer to our objective of offering patients a safe and effective first line therapy for the treatment of secondary progressive multiple sclerosis, with the convenience of two I.V. doses per year."

"The clinical investigators, study site personnel and BioMS Medical's drug development team all have done an outstanding job of recruiting patients and conducting this trial at the highest quality standards," said Dr. Kjell Stenberg, Chief Operating Officer of BioMS Medical. "The need and enthusiasm for this project in the MS community is well recognised and the results of this pivotal study are eagerly awaited."

MAESTRO-01 Trial

The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The study is being conducted at 48 sites across Canada and Europe and will include approximately 550 patients being administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(23/01/07)

"The clearance to proceed with a phase III trial in the U.S. is a significant step towards bringing MBP8298 to the worldwide market," said Kevin Giese, President and CEO of BioMS Medical. "There are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive MS. Between the U.S. initiative and the on-going pivotal phase III trial in Canada and Europe, we are successfully executing our global development plan for MBP8298."

The IND allows the commencement of a pivotal phase III secondary progressive MS clinical trial in the US and has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the completed and ongoing clinical studies for MBP8298.

MAESTRO-03 Phase III US Trial

The pivotal phase III clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

About MBP8298 - Novel Mechanism of Action

In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise "tolerant" of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.

MAESTRO-01 Trial

The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is currently being conducted at more than 50 sites across Canada and Europe and will enroll approximately 550 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(19/01/07)

This was the sixth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The pivotal phase II/III study is now ongoing at trial sites across Canada and Europe.

Source: BioMS Medical Corp.(08/12/06)

"This is a major milestone in our strategy to advance our lead drug into a second indication," said Mr. Kevin Giese, President of BioMS Medical. "MBP8298 has shown potential to significantly delay disease progression in secondary progressive MS (SPMS) patients with immune response genes HLA-DR2 and/or DR4 and we look forward to evaluating the potential efficacy of our lead drug in RRMS patients, who represent an equally large patient population."

The fifteen month, double-blind, placebo-controlled trial will enroll up to 215 patients with RRMS from up to 30 sites. The trial will be followed by a 12 month active treatment open label extension period. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

RRMS and SPMS each affect 40 - 45% of the estimated 2.5 million MS patients worldwide. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for up to 75% of the MS patient population.

MBP8298 is also currently undergoing a pivotal phase III trial for the treatment of secondary progressive multiple sclerosis (SPMS), with interim data from this trial anticipated in approximately 18 months.

Source: BioMS Medical Corp. 24/11/06

Professor Hartung is Professor and Chairman, Department of Neurology at Heinrich-Heine-Universität Dusseldorf in Germany.

"Professor Hartung is world renowned in the area of multiple sclerosis and we are very pleased to have his support and involvement in our international pivotal phase III trial for MBP8298," said Kevin Giese, President and CEO of BioMS Medical.

Professor Hartung serves on a number of executive boards, including ECTRIMS as President, the European Charcot Foundation, the International Society of Neuroimmunology, WHO Working Group on Multiple Sclerosis, GBS Foundation International, the Medical Advisory Board of the International (MSIF) and the German MS Society. He is also member of the Editorial Board of a number of international journals. Professor Hartung is a Corresponding Fellow of the American Academy of Neurology and American Heart Association and Corresponding Member of the American Neurological Association. Professor Hartung has authored or co-authored more than 400 articles in peer-reviewed journals, contributed more than 80 book chapters and edited seven books.

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada and Europe in its pivotal Phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(16/11/06)

The most recent patent, entitled "Methods of predicting therapeutic efficacy of treatment of a multiple sclerosis patient" has been granted in the United States and addresses methods of predicting efficacy of certain courses of treatment for MS patients.

"We are pleased about our recent patent protection in the United States. Protection of the Company's intellectual property, in the United States and throughout the world, represents a key aspect of our commercial development. It also provides a view into the excellent scientific and clinical development supporting this important MS drug." said Kevin Giese, President and CEO of BioMS Medical.

In total, BioMS has exclusive licenses to 99 granted patents in 34 countries throughout the world.

Source: BioMS Medical Corp.(02/11/06)

"We are pleased that multiple sclerosis patients from the Baltic States will be included in our multi-national pivotal phase III trial," said Kevin Giese, President and CEO of BioMS Medical. "By expanding our trial across Europe as planned, a wider range of MS patients and their treating physicians will be exposed to MBP8298, broadening awareness for our drug which has the potential to dramatically alter the progression of MS."

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K., Germany, Sweden, the Netherlands, Spain, Denmark, and Finland in its pivotal Phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp. (24/10/06)

"Based on the results we have generated to-date, MBP8298 appears to have the potential to fundamentally alter the course of this devastating disease," said Kevin Giese, President and CEO of BioMS. "We are pleased to be able to include patients from Finland in this important multi-national trial. The population in Finland suffers disproportionately from multiple sclerosis and like BioMS is committed to the development of an effective treatment."

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K., Germany, Sweden, the Netherlands, Spain, and Denmark in its pivotal Phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(12/10/06)

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K., Sweden, Denmark and The Netherlands in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(07/09/06)

This was the fifth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The pivotal phase II/III study is now ongoing at trial sites across Canada, the U.K., Sweden, Denmark, and The Netherlands.

Source: BioMS Medical Corp.(15/08/06)

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K., Sweden and Denmark in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed four safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(22/06/06)

Long-term efficacy and safety shown in multiple sclerosis patients.

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today, Tuesday June 13, announced that results of the phase II and long-term follow-up treatment of MS patients with MBP8298 have been published in the European Journal of Neurology (EJN). The publication highlights long-term efficacy, safety and mechanism of action data in respect of MBP8298. The journal also features an editorial entitled "The coming of age for antigen-specific therapy of multiple sclerosis." The data was published in the EJN online early issue and is expected to appear in the August 2006 printed issue.

The results show that MBP8298 safely delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. Treatment and follow-up of patients demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75% of MS patients, had a median time to disease progression of 78 months as compared to 18 months for patients who received placebo.

"Our data suggest that we can safely delay progression of MS in an identified responder group of patients for extended periods of time," said Ingrid Catz, co-inventor of MBP8298 and co-author of the phase II study. "Recognising the high variability of the disease in MS patients, the clinical and mechanistic evidence gathered to date supports the rationale of targeting patients with the HLA-DR2 or HLA-DR4 immune response gene. The identification of this responder group will improve efficiency toward the achievement of objectives in future clinical trials with MBP8298, while the potential for clinical responses in patients with other HLA haplotypes is further explored."

"While this is phase II data and needs to be confirmed in the ongoing phase III trial, it is very hopeful information for MS patients," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and Director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital. "To delay disease progression for five years in progressive MS patients is a big step - there are currently very limited options available to treat this form of multiple sclerosis."

"The MS Society is pleased to hear about the positive results from this clinical trial and will watch closely the Phase III clinical trials," adds Dr. William J. McIlroy, national medical advisor for the MS Society of Canada. "Having a drug that treats progressive MS would be very well received."

Phase II and Long Term Study Results

The Phase II study followed 32 patients with clinically diagnosed, MRI-confirmed progressive MS for 24 months, comparing safety and efficacy between MBP8298 and placebo administered intravenously every six months. Patients with the HLA-DR2 and/or HLA-DR4 immune response genes were identified as the key responder group, with no HLA-DR2 and/or DR4 patients on MBP8298 demonstrating progression during the initial 24 months, as compared to over 50% of the patients on placebo (p(equal sign)0.01).

After 5 years of open label follow-up treatment, comparison of disease progression in the HLA-DR2 or DR4 patients receiving MBP8298 with those in the original placebo group showed that the median time to first confirmed progression on EDSS was 78 months compared to 18 months for patients who had received placebo (Kaplan-Meier analysis, p (equal sign) 0.004, relative rate of progression (equal sign) 0.23). Patients were entered into the trial as matched pairs, had comparable baseline characteristics, and were randomized on a 1:1 basis between drug and placebo. Measurements of progression on EDSS followed the standard scoring method of one full point change for those patients with a starting EDSS score of 5.0 or less, and one half point change for those patients with a starting score of 5.5 or higher.

No serious adverse events were reported during the trial and follow up period, with MBP8298 appearing to be well tolerated. The most common side effect reported was occasional injection site redness and burning that was not seen to be evident of increased hypersensitivity or allergic reaction, and with as many placebo patients in the double blind trial reporting this side effect as patients receiving drug. To date, there are more than 300 patient years of treatment experience with the longest individual patient treatment period now at more than 12 years.

Novel Mechanism of Action

In MS patients the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise "tolerant" of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the IV injection of a large dose of a soluble antigen, as represented by MBP8298, into MS patients. The phase II results published in the EJN demonstrated significant evidence of this "tolerance" effect, as HLA-DR2 and HLA-DR4 patients not only responded clinically to MBP8298, but they also had their antibodies to Myelin Basic Protein suppressed during the course of their treatment. This effect was achieved through the treatment regimen of one intravenous injection two times per year.

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K., Sweden and Denmark in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed four safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(16/06/06)

The trial is a 12 month, double blind, placebo-controlled trial and will enroll up to 215 RRMS patients. The trial will be followed by a 15 month active treatment open label extension period. The primary objective of the study is to demonstrate efficacy and safety of MBP8298 versus placebo in patients who are positive with immune response genes HLA-DR2 or HLA-DR4. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for up to 75% of the MS patient population.

"In addition to our on-going phase III trial for secondary-progressive MS (SPMS), expanding our clinical program into RRMS is significant as the combined patient population for these two indications represent approximately 90% of all MS patients," said Kevin Giese, President of BioMS Medical.

Source: BioMS Press Release (16/05/06)

"Adding these additional trial sites to our ongoing pivotal MS trial will provide us with a broader population base for enrolment and strengthen our presence in Europe beyond the United Kingdom and Sweden into Denmark," said Kevin Giese, President of BioMS Medical.

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K. and Sweden in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed four safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp. Press release (10/05/06)

- More than 200 patients enrolled in Phase II/III trial for MBP8298

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced that more than 200 patients have been enrolled in its pivotal phase II/III clinical trial for the treatment of secondary progressive multiple sclerosis (SPMS). An interim safety and efficacy analysis will be performed on data from the first 200 patients enrolled when they have completed 24 months of the clinical trial.

“This is an important milestone event as it sets the clock as to when the independent Data Safety Monitoring Board (DSMB) will initiate their review of the interim data and report on any significant preliminary findings,” said Kevin Giese, President of BioMS Medical. “With more than 200 patients enrolled and close to 300 patients screened to-date, our pivotal trial is progressing very well.”

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada, the U.K. and Sweden in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes.  Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed four safety reviews by its independent Data Safety Monitoring Board.

Source: BioMS Medical Corp.(09/05/06)

"The recommendation by the independent DSMB strengthens our confidence as we move towards the completion of our pivotal trial," said Kevin Giese, President of BioMS Medical.

This was the fourth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The pivotal phase II/III study is now ongoing at trial sites across Canada, the U.K. and Sweden.

Source: BIOMS MEDICAL CORP. Press release.(04/05/06)

Treatment and follow-up of patients from a phase II clinical study demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75% of MS patients, had a median time to disease progression (worsening) of 78 months compared to 18 months for patients who received placebo.

"These results show an unprecedented 5-year improvement in time to disease progression in the majority of progressive MS patients," said Kevin Giese, president and CEO of BioMS Medical. "Pending confirmation of these results in our ongoing international pivotal trial in secondary progressive MS, we anticipate that MBP8298 will represent a novel first in class treatment for MS patients."

The findings are based on a 2-year treatment and 5-year follow-on study conducted and analyzed by the University of Alberta and BioMS Medical. The primary objective of the trial was to assess the clinical efficacy of 500mg of MBP8298 administrated intravenously every 6 months, as measured by the Expanded Disability Status Scale (EDSS).

Long-term follow-up treatment and assessment of 20 progressive MS patients with the HLA-DR2 or HLA-DR4 immune response genes demonstrated a median time to progression of 78 months (6.5 years) for MBP8298 treated patients compared to 18 months (1.5 years) for patients treated with placebo in the initial study (Kaplan-Meier analysis, p=0.004).

Source: Therapeutics Daily Copyright 2006, Immunotherapy Weekly via NewsRx.com.(06/04/06)

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced that it is expanding the clinical development program for its lead drug candidate MBP8298. The drug is currently undergoing an international pivotal phase II/III clinical trial with secondary progressive MS patients (SPMS). BioMS now plans to initiate a clinical trial for MBP8298 in relapsing-remitting MS (RRMS) patients in the second half of 2006.

“We have good scientific rationale to believe that MBP8298 has the potential to provide a benefit to MS patients at any stage of the disease,” said Kevin Giese, President and CEO of BioMS Medical. “If our drug is able to show efficacy in relapsing-remitting MS patients as it has in trials with secondary progressive MS patients, then it would represent a great benefit for this equally large MS population.”

MS affects approximately 2.5 million people worldwide, of which 40-45% have RRMS and 40-45% have SPMS.

BioMS Medical recently announced study results demonstrating that MBP8298 delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. These findings will be presented at the 58th Annual Meeting of the American Academy of Neurology on April 4, 2006 in San Diego, CA.

Source: BioMS Medical Corp. Press Statement (15/03/06)

Under the terms of the agreements, UCB-Bioproducts will continue to manufacture the MBP8298 bulk drug and Hospira will fill and finish the drug product into vials for use in patients. These contracts contemplate these companies providing their services through the current pivotal clinical trial for MBP8298 and into commercial production.

"These agreements emphasize our commitment to bring a quality, first-in- class therapeutic to MS patients and are important to the success of the anticipated future launch of MBP8298 into the marketplace," said Kevin Giese, President of BioMS Medical. "Both UCB and Hospira are public companies, world- leaders in quality manufacturing and recognized experts in their field of work."

About UCB

With more than 30 years of experience dedicated to peptide API contract manufacturing, UCB-Bioproducts is the world-leader in pharmaceutical peptides and peptidomimetics', supporting customers' projects with services from preclinical to commercialization through clinical development. UCB-Bioproducts is a division of UCB, a global biopharmaceutical leader headquartered in Brussels, Belgium, with manufacturing facilities in Europe, US and Sales and Marketing offices in Europe, US and Japan. UCB employs over 8,500 people operating in over 40 countries worldwide.

About BioMS Medical Corp.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is currently in a pivotal phase II/III clinical trial across Canada and Europe.

Source: BioMS Medical Corp.(15/02/06)

"The DSMB reviewed safety data from our trial, including data from MRI scans conducted on the first 100 patients dosed in study, who are undergoing an extensive safety analysis as per the trial design," said Kevin Giese, President of BioMS Medical. "This third positive recommendation by the DSMB members highlights the steady progress being made in advancing our pivotal trial."

This was the third of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The pivotal phase II/III study is now ongoing at trial sites across Canada, the U.K. and Sweden.

Source: BioMS Medical Corp. (07/02/06)

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced that the first patients in the United Kingdom have been enrolled in its pivotal Phase II/III clinical trial for MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive MS. Patient enrollment is now active across both Canada and the U.K.

"The successful expansion of our pivotal trial into Europe is an important milestone for BioMS. The European market represents a significant portion of MS patients globally with approximately 100,000 MS patients in the U.K. and 450,000 across Europe," said Mr. Kevin Giese, President of BioMS Medical. "The expansion of this trial into Europe is expected to continue with the addition of another jurisdiction in the near future."

The trial is expected to enroll up to 553 patients and will be a double-blind, placebo-controlled study. Patients will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS) in the previously identified responder group, patients with immune response genes HLA-DR2 or HLA-DR4. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for up to 75% of the MS patient population.

Source: BioMS Medical Corp (08/12/05)

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Swedish Medical Products Agency (MPA) for its pivotal Phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).

"We are very pleased to expand this trial into Sweden. Sweden has a
higher prevalence of MS, similar to that of the U.K., Canada and the northern U.S. and as a result, the country conducts leading edge research on the disease. This is an important opportunity for us to conduct our trial in another population where clinicians have extensive experience with MS and where there is a large unmet need for an effective treatment," said Kevin Giese, President of BioMS Medical. "We anticipate a lead investigator for Sweden will be announced shortly and that the first patients from Sweden will be enrolled into the trial in the coming months."   

The trial, which is currently enrolling patients in Canada and the U.K.
is a double-blind, placebo-controlled study involving up to 553 patients.
Patients will be administered either MBP8298 or placebo intravenously every six months for a period of two years. While SPMS patients with any genetic profile will be included, the primary clinical endpoint for the trial is
defined as a statistically and clinically significant increase in the time to
confirmed worsening of disability as measured by the Expanded Disability
Status Scale (EDSS) in the previously identified responder group, patients
with immune response genes HLA-DR2 or HLA-DR4. Patients with these immune response genes account for up to 75% of the MS patient population.

Source: BioMS Medical Corp. (07/12/05)

BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company's pivotal phase II/III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis and recommended that the trial may continue.

"BioMS is confident that MBP8298 will continue to demonstrate a good safety profile," said Kevin Giese, President of BioMS Medical. "Through previous clinical work, MBP8298 has gathered more than 300 total patient years of treatment experience and more than 30 patients still receive follow-on treatment with this drug today, with the longest period of treatment currently at 12 years."

This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The pivotal phase II/III study is now ongoing at trial sites across Canada and the U.K.

Source: BioMS Medical Corp. (07/12/05)

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