MBP-8298 update

scoobyjude · Posted: Mon Mar 05, 2007 6:59 pm Post subject: MBP-8298 update

BioMS Medical: potential to broaden MS treatment options
2nd March 2007
By Charlotte Mackey

BioMS commences phase II/III extension trial for MBP-8298 in the treatment of multiple sclerosis

BioMS has initiated an open-label extension of its MAESTRO-01 pivotal phase II/III trial of MBP-8298 in patients with secondary progressive multiple sclerosis. MBP-8298 has the potential to broaden the currently narrow treatment options for this form of MS as well as offering an improved dosing regimen.

'Content BioMS, a leading developer of products for the treatment of multiple sclerosis (MS), has initiated MAESTRO-02, an open-label extension of its MAESTRO-01 pivotal phase II/III trial of MBP-8298 for the treatment of secondary progressive multiple sclerosis (SPMS).

MAESTRO-02 is being conducted in Canada and Europe and will provide additional long-term safety and efficacy data to support regulatory submissions. The phase III MAESTRO-03 trial for secondary progressive MS is due to start in the US in the first half of 2007. MBP-8298 is also being evaluated in a phase II study in Europe for relapse-remitting MS.

Multiple sclerosis is an idiopathic inflammatory disease of the central nervous system, characterized pathologically by demylelination and subsequent axonal degeneration. Over 800,000 individuals across the US and EU are estimated to suffer from MS; approximately 20% are diagnosed with SPMS. In 2006, the six approved disease-modifying drugs for MS yielded sales of $4.6 billion across the seven major markets.

At present, only two of disease-modifying drugs, Betaseron (interferon beta-1b; Schering AG) and Novantrone (mitoxantrone; Serono) are indicated for SPMS. However, neither drug is 100% effective and each is associated with a variety of side effects, albeit of a varying severity. As such, there is still a need for new treatments with improved disease-modifying efficacy and fewer side effects.

Like Novantrone (and natalizumab; marketed as Tysabri by Biogen Idec and Elan), MBP-8298 is administered by intravenous infusion. Although this could undoubtedly limit its use to those patients who have access to a specialist unit, the 'once every six month' dosing frequency is a clear advancement in comparison to Novantrone's three-monthly infusion.

However, showing long-term safety and efficacy in SPMS will be the key to MBP-8298's commercial success - if MBP-8298 can demonstrate positive long-term safety and efficacy in phase II/III trials, the drug would offer a viable alternative to first-line Betaseron therapy, thereby pushing Novantrone further down the treatment algorithm. 'End Intelliext