MBP8298

A board to discuss future MS therapies in early stage (Phase I or II) trials.

MBP8298

Postby dignan » Wed May 03, 2006 7:52 am

Not big news, but it's another hurdle jumped...



BioMS Medical's pivotal multiple sclerosis trial receives fourth positive review from Data Safety Monitoring Board

May 3 - CNW - BioMS Medical today announced that following the fourth meeting of the independent Data Safety Monitoring Board (DSMB), the Company has received a recommendation to continue its pivotal phase II/III clinical trial for MBP8298 for the treatment of secondary progressive multiple sclerosis.

"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.

http://www.newswire.ca/en/releases/arch ... c2994.html
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Postby dignan » Tue May 09, 2006 7:45 am

Another update...



BioMS Medical reaches milestone in pivotal multiple sclerosis trial

May 9 - CNW - BioMS Medical Corp 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."

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.

http://www.newswire.ca/en/releases/arch ... c4583.html
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Postby dignan » Wed May 10, 2006 8:06 am

Lots of news about this one lately...



BioMS Medical expands pivotal multiple sclerosis trial into Denmark

May 10 - CNW - BioMS Medical Corp today announced it has received approval from the Danish Medicines Agency to start patient enrolment in Denmark for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).

"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.

http://www.newswire.ca/en/releases/arch ... c4741.html
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Postby Dunmann » Tue May 16, 2006 6:04 am

This time a new study for RRMS.


BioMS Medical receives regulatory approval for phase II relapsing-remitting multiple sclerosis trial
Tuesday May 16, 8:00 am ET

Toronto Stock Exchange Symbol: MS
EDMONTON, May 16 /CNW/ - BioMS Medical Corp (TSX: MS - News), a leading developer of products for the treatment of multiple sclerosis (MS), announced that it has received regulatory approval to initiate a phase II human clinical trial to investigate the efficacy and safety of MBP8298 in patients with relapsing-remitting multiple sclerosis (RRMS) in the first of several European countries. Patient enrollment is targeted to commence in the third quarter of this year and BioMS anticipates up to 30 sites will participate.

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.
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Postby Dunmann » Tue Jun 13, 2006 5:45 am

New data from phase II.

European Journal of Neurology publishes MBP8298 phase II and long-term follow-up data
Tuesday June 13, 8:00 am ET

Toronto Stock Exchange Symbol: MS
EDMONTON, June 13 /CNW/ - BioMS Medical Corp (TSX: MS - News), a leading developer in the treatment of multiple sclerosis (MS), today 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. "Recognizing 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.

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. For further information please visit our website at www.biomsmedical.com.

This news release may contain certain forward-looking statements that

reflect the current views and/or expectations of BioMS Medical with respect to
its performance, business and future events. Such statements are subject to a
number of risks, uncertainties and assumptions. Actual results and events may
vary significantly.

For further information

Tony Hesby or Ryan Giese, Corporate Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com
James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com
Mr. Barry Mire, Investor Relations, (514) 939-3989, E-mail: bmire@renmarkfinancial.com
MEDIA Contact: Sarah Rutka, Fleishman-Hillard Canada, (416) 645-8191, Email: sarah.rutka@fleishman.ca
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Postby dignan » Thu Jun 22, 2006 8:24 am

More news...



BioMS Medical expands pivotal multiple sclerosis trial into The Netherlands

June 22 - CNW - BioMS Medical today announced it has received approval to start patient enrolment in The Netherlands for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS). Approval was received from the Competent Authority in The Netherlands, CCMO (Central Committee on Research Involving Human Subjects).

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.

http://www.newswire.ca/en/releases/arch ... c8408.html
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