BioMS Medical Presents at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis
EDMONTON, Alberta, Oct. 15, 2007/CNW/ - BioMS Medical Corp.
(TSX: MS), a leading developer in the treatment of multiple
sclerosis (MS), today announced that interim safety
observations from MAESTRO-01, the Company's on-going phase
III trial of MBP8298 for the treatment of secondary
progressive MS, were reported in a poster presentation at the
23rd Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech
Republic. A second poster presentation reported the percentage of
patients screened for the trial that had the target
HLA-DR2/DR4 immune response
ECTRIMS is one of the largest and most prestigious annual MS conferences, bringing together MS experts and thought leaders from around the world to discuss the latest MS research findings. The first poster, entitled "Safety observations from administration of MBP8298 as part of the ongoing phase III MAESTRO-01 secondary progressive MS clinical trial", showed that MBP8298 administration resulted in no significant safety concerns measured over the current course of the MAESTRO-01 study.
The second poster, entitled "Haplotype analysis of Secondary Progressive Patients participating in the MAESTRO-01 Study", showed that overall, amongst the 10 countries enrolling patients in the MAESTRO-01 trial, (Canada, United Kingdom, Finland, Denmark, Sweden, Estonia, Latvia, Spain, Germany and the Netherlands) 70.38% of the 788 screened patients were observed to have HLA-DR2 and/or HLA-DR4 immune response genes.
"The first poster presentation demonstrates that the safety profile of our drug continues to look strong in a large multinational clinical trial setting," said Kevin Giese, President and CEO of BioMS. "The second poster reaffirms that MS patients with HLA-DR2/DR4 immune response genes, potentially account for more than 70% of the overall MS population in Europe and Canada."
About MBP8298 - Novel Mechanism of
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 "tolerant" of such normal 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 and is fully recruited with 611
- 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 (RRMS). The trial is a randomized, double-blind study and is fully recruited with 218 patients.
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, 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 http://www.biomsmedical.com.
This press release may contain forward-looking statements, which reflect the Company'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 Company'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 MBP8298 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.
For further information: Tony Hesby, Ryan Giese, Corporate Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: firstname.lastname@example.org, Internet: http://www.biomsmedical.com; James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: email@example.com
Posted: October 2007