BIOMS MEDICAL CORP.
Attention Business/Financial Editors
BioMS Medical announces first quarter 2007 results
Toronto Stock Exchange Symbol: MS
EDMONTON, May 15 /CNW/ - 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
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
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
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.
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.
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
/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: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail:
email@example.com/Submitted 5/15/2007 10:19:39 PM