MBP8298 update

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

MBP8298 update

Postby dignan » Tue Mar 07, 2006 9:05 am

This sounds promising, although they don't provide much information here...

BioMS Medical's MBP8298 Shows Five-year Delay of Disease Progression in Patients with Multiple Sclerosis

March 7, 2006- BioMS Medical today announced that its proprietary drug candidate MBP8298 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 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 two-year treatment and five-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 six 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 equals 0.004). Details of the study and its findings will be presented at the 58th Annual Meeting of the American Academy of Neurology on April 4, 2006 in San Diego, CA.

Phase II/III Pivotal 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). To date the trial has successfully completed three safety reviews by its independent Data Safety Monitoring Board.

http://www.pharmalive.com/News/index.cf ... egoryid=40
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Postby bromley » Tue Mar 07, 2006 2:55 pm

Thanks Dignan and Dunmann,

I think the company has been working on this drug for 20 years.

I'm not clear what 'delayed disease progression' means - does it mean no movement up the EDSS scale?

I'm also unsure as to why they didn't trial on PP and RR patients. Even in RR patients you can 'progress' up the scale as a result of attacks.

Given what look like impressive results - I wonder why the company aren't allowed to bring this to market quicker. Safety would have been tested at Phase I and Phase II. And effectiveness has been shown over a long period of time - five years. For those with SP MS, it seems cruel to say that we've got something that works but you wouldn't be able to get hold of it for 3-4 more years.

But maybe things are looking up in 2006 (at least compared with last year).

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