EDMONTON, May 3 /PRNewswire-FirstCall/ - BioMS Medical Corp , a leading developer of products for the treatment of multiple sclerosis (MS), today announced that it has completed patient recruitment in its phase II clinical trial of MBP8298 for the treatment of relapsing-remitting MS (RRMS). The trial, named MINDSET-01, includes approximately 215 patients, and is being conducted at 24 trial sites in six countries across Europe.
“Reaching full recruitment in our relapsing-remitting MS trial in less than six months after initiating enrollment reflects the drive and dedication of our clinical team and all those involved in this trial,” said Kevin Giese, President and CEO of BioMS Medical. “While there are current approved therapies for the relapsing-remitting form of MS, there is still a great need for treatments that are more convenient, safe and effective in treating the disease. MBP8298 has the potential to benefit patients with all forms of MS and with the long-term safety data it has generated to date, we believe MBP8298 would be greatly received.”
MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial will be followed by a 12 month active treatment open label extension period. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.
About MBP8298 - 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 I.V. injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
MBP8298 is being developed in three late-stage clinical trials: - MAESTRO-01: A pivotal phase III trial in Canada and Western Europe evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study with 611 recruited patients. - MAESTRO-03: A pivotal phase III U.S. trial evaluating MBP8298 for the treatment of SPMS. The trial is a randomized, double-blind study enrolling approximately 510 patients. - MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of relapsing-remitting multiple sclerosis. The trial is a randomized, double-blind study of approximately 215 patients. About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 75,000 in Canada, 400,000 in the United States and more than 450,000 in Western Europe. MS is a progressive disease of the central nervous system, characterized initially by episodes of paralysis, blindness, sensory disturbances and cognitive impairment.
About BioMS Medical Corp.
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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 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. 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.
BioMS Medical Corp.
CONTACT: Tony Hesby, Ryan Giese, Corporate Communications, BioMS MedicalCorp., (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
