BioMS Medical Announces First Quarter 2007 Results
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Edmonton, Alberta, May 15, 2007 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced results for the first quarter ended March 31, 2007.
“During the first quarter we completed enrolment in our Canadian and European pivotal secondary progressive MS trial and received clearance to initiate a second pivotal phase III trial for MBP8298 in secondary progressive MS in the United States,” said Kevin Giese, President and CEO of BioMS. “We maintained this momentum into the second quarter, announcing the lead investigator for our U.S. pivotal trial, for which we anticipate initiating patient enrolment in the coming weeks, and completing enrolment in our MINDSET-01 relapsing-remitting MS trial.”
Update on clinical trials:
MAESTRO-01: Pivotal phase II/III secondary progressive MS trial (Canada/Europe)
During the first quarter, BioMS completed patient recruitment in its pivotal trial of MBP8298. The trial has enrolled 611 patients, which represents an over-enrolment of approximately 10%.
Subsequent to the end of the quarter, this trial received a positive interim safety analysis based upon an assessment of the first 100 patients enrolled in the study who had completed twelve months of treatment. In-depth safety data, including extensive MRI scans, were collected for this patient group. The next interim analysis, anticipated to occur in mid-2008, will look at both safety and efficacy in the first 200 patients who have completed 24 months of the clinical trial.
MAESTRO-02: Follow-on open-label secondary progressive MS trial
During the first quarter, BioMS initiated the follow-on open-label portion to its MAESTRO-01 pivotal trial. Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.
MAESTRO-03: Pivotal phase III secondary progressive MS trial (United States)
During the first quarter, BioMS received clearance by the U.S. FDA to initiate a pivotal phase III in secondary progressive MS. MAESTRO-03 will be a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years Subsequent to the end of the quarter, BioMS announced the lead investigator for the trial, Dr. Clyde E. Markowitz, Director of the Multiple Sclerosis Center at the Hospital of the University of Pennsylvania in Philadelphia.
MINDSET-01: Phase II relapsing-remitting MS trial
Subsequent to the end of the quarter, BioMS completed enrolment in its phase II trial evaluating MBP8298 for the treatment of relapsing remitting MS. The trial is a randomized, double-blind study enrolling up to 215 patients.
Financial Results:
The consolidated net loss for the first quarter ended March 31, 2007 was $12.9 million or ($0.17) per share compared to a consolidated net loss of $8.5 million or ($0.14) per share for the first quarter of the previous year. Cash used in the quarter was $10.7 million, as per Company expectations for the period. Non-cash expenses related to stock-based compensation and amortization of licensing costs and property and equipment accounted for the balance of the net loss.
Total consolidated expenses for the first quarter of 2007 were $13.3 million compared to $8.9 million for the first quarter of 2006. Research and development expenses totalled $10.3 million for the first quarter of 2007 compared to $6.7 million for the first quarter of 2006. Research and development expenses increased as a result of the increased number of clinical trial sites participating in the MAESTRO-01 clinical trial for MBP8298 and the increased number of patients participating in the trial.
General and administration expenses totalled $2.6 million for the first quarter of 2007 compared to $1.8 million for the first quarter of 2006.
As at March 31, 2007, cash and short-term investments totalled $34.2 million as compared to $43.1 million as at December 31, 2006. At March 31, 2007, the Company had working capital of $26.7 million as compared to $37.4 million at December 31, 2006.
As at March 31, 2007 the Company had 75,256,923 common shares outstanding and 17,971,528 warrants and 7,821,500 options outstanding.
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 www.biomsmedical.com.
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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 (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.
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| Ryan Giese VP Corporate Communications Phone: 780-413-7152 rgiese@biomsmedical.com |
Tony Hesby Executive VP Corporate Affairs Phone: 780-413-7152 thesby@biomsmedical.com |
Amanda Stadel Investor Relations Manager Phone: 780-413-7152 astadel@biomsmedical.com |