Posted by: Thixia | August 11, 2008

Patient recruitment completed in phase III MBP8298

Patient recruitment completed in phase III MBP8298 multiple sclerosis trial       

 

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.    

 

 

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