BioMS Medical reports results of exploratory phase II trial of dirucotide in relapsing remitting multiple sclerosis
Toronto Stock Exchange Symbol: MS
EDMONTON, Jan. 30 /PRNewswire-FirstCall/ - BioMS Medical Corp. , a leading developer in the treatment of multiple sclerosis (MS), today announced results from MINDSET-01, an exploratory phase II clinical trial evaluating dirucotide in patients with relapsing-remitting MS. The lead clinical development program for dirucotide is for secondary progressive MS where it is being evaluated in two ongoing phase III trials in the United States, Canada and Europe, with results from the Canadian and European MAESTRO-01 trial expected in the second half of 2009.
The results of the MINDSET-01 study showed that dirucotide did not meet its primary endpoint, annualized relapse rate or associated secondary MRI endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the disease, including mean change from baseline in the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) score. The EDSS is a method of quantifying disability in MS, while the MSFC evaluates additional functional parameters. Measuring changes in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III secondary progressive MS trials.
The data also showed that dirucotide was generally well tolerated. The most common side effects reported were redness and burning sensation at the injection site. No patients withdrew due to adverse events.
BioMS and its partner Eli Lilly & Company (Lilly) will continue to analyze the results of this exploratory phase II trial. Under the terms of the licensing agreement with Lilly, no milestone payment was associated with this trial.
"We are encouraged that dirucotide has demonstrated an effect on certain clinical measures of disease progression, this time in the earlier form of the disease," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide was developed as a potential treatment for patients with progressive MS and we believe that these results are consistent with the nature of the therapy, and what is understood about dirucotide's method of action."
About MINDSET-01 Study ----------------------
The MINDSET-01 study was a fifteen month, phase II, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of dirucotide in patients with relapsing-remitting MS. The trial enrolled 218 patients at 24 sites in 6 European countries, with eligible patients randomized on a equal 1:1 basis to receive a total of three single intravenous doses of either drug or placebo at 0, 3 and 9 months. The study enrolled patients into two sub-groups: 154 patients testing positive for the HLA-DR2 and/or HLA-DR4 immune response gene; and 64 patients testing negative for the HLA-DR2 and HLA-DR4 gene. The study was designed to additionally have a 12 month active treatment open label extension period which will provide further safety and efficacy data.
BioMS is conducting ongoing pivotal clinical trials evaluating the ability of dirucotide to affect disease progression in patients with secondary progressive MS: - MAESTRO-01: A Canadian/European pivotal phase III trial evaluating dirucotide for the treatment of secondary progressive MS (SPMS). The study has completed full recruitment of 611 patients at 47 trial sites in nine countries. To date, there have been nine positive safety reviews from the Data Safety Monitoring Board (DSMB). Full analysis of this trial is expected in the second half of 2009. - MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal trial. Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial may choose to receive dirucotide on an un-blinded basis in MAESTRO-02. Of patients who have successfully completed MAESTRO-01 to date, approximately 95 percent have entered the follow-on study. - MAESTRO-03: A U.S. pivotal phase III trial evaluating dirucotide for the treatment of SPMS. The trial is fully recruited with approximately 510 patients enrolled at 68 sites across the U.S. To date, the DSMB has conducted three reviews of the data from this trial and has recommended it continue. Webcast -------
BioMS Medical management will host a conference call at 8:30 a.m. (EST) on January 30, 2009, 2009 to discuss the MINDSET-01 trial. Participants may listen via an audio web cast, accessible through the Company's website at www.biomsmedical.com or via telephone. The telephone conference number is 416-644-3415 or toll-free at 800-732-9303.
About Dirucotide ----------------
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). Dirucotide is being investigated 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 dirucotide 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 approximately 70 percent of all MS patients.
The drug's proposed mechanism of action is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide periodically delivered intravenously. The potential benefit of the drug for any individual patient is therefore expected to be related to the role this peptide plays in that patient's immune system and disease process. 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 dirucotide, published in 2006 in the European Journal of Neurology (EJN), showed that dirucotide delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4, and generally well tolerated.
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, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for Relapsing Remitting MS patients in a phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com
This press release may contain forward-looking statements, which reflect the Corporation's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Tony Hesby, Ryan Giese, Amanda Stadel, BioMS Medical Corp., (780)413-7152, (780) 408-3040 Fax, E-mail: , Internet:http://www.biomsmedical.com; James Smith, Investor Relations, (416)815-0700 ext. 229, (416) 815-0080 Fax, E-mail: firstname.lastname@example.org email@example.com
Ticker Symbol: (Toronto:MS)
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Posted: January 2009