Toronto Stock Exchange Symbol: MS
New York Stock Exchange Symbol: LLY
INDIANAPOLIS, Indiana and EDMONTON, July 27 /CNW/ - Eli Lilly and Company
(NYSE: LLY) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide
did not meet the primary endpoint of delaying disease progression, as measured
by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01
Phase III trial in patients with secondary progressive multiple sclerosis
(SPMS). In addition, there were no statistically significant differences
between dirucotide and placebo on the secondary endpoints of the study.
The data also showed that dirucotide was generally well tolerated. There
were no unexpected safety or tolerability issues. The most common side effect
reported was injection site reaction. More details of the MAESTRO-01 study
results are expected to be presented at a medical conference later this year.
Lilly and BioMS also announced they would discontinue ongoing clinical
trials - including MAESTRO-02 and MAESTRO-03 - and review the available data
from these studies. MAESTRO-02 is an open-label follow-on study to MAESTRO-01.
MAESTRO-03 is a 510-patient U.S. Phase III clinical trial designed to evaluate
dirucotide for the treatment of SPMS that completed enrollment in August 2008.
Lilly and BioMS will inform regulatory agencies and provide instructions to
investigators outlining the process for discontinuing the studies. Patients
involved in studies who have questions should contact their study
investigator.
"The MAESTRO-01 study was well designed and executed, and we believe
these data, while disappointing, are very instructive for us and for the
larger MS community," said John Hayes, vice president of Lilly Research
Laboratories. "We look forward to further conversations with BioMS Medical
about this project."
"We are obviously disappointed by this result and will be working closely
with our clinical team to evaluate these data and the available data from
MAESTRO-02 and MAESTRO-03 to determine our next steps," said Kevin Giese,
President and CEO of BioMS Medical. "We are fortunate to have suitable
resources in place to remain flexible to pursue whatever options emerge once
we understand these results more fully."
BioMS Medical Webcast
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Participants may listen to a discussion of the outcome of the MAESTRO-01
study by Kevin Giese, President and CEO of BioMS Medical. The audio webcast is
accessible through the Company's web site at www.biomsmedical.com.
About MAESTRO-01
----------------
MAESTRO-01 was a multi-center, double-blind, placebo-controlled trial
designed to evaluate the safety and efficacy of dirucotide in patients with
SPMS.
