MEDIA RELEASE PR35529
Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in
Secondary Progressive Multiple Sclerosis
INDIANAPOLIS and EDMONTON, July 28 /PRNewswire-AsiaNet/ --
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
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
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. The study was conducted in Canada and nine countries in Europe and
included 612 patients being administered either dirucotide or placebo
intravenously every six months for a period of two years.
The primary clinical endpoint for the trial was defined as a
statistically significant increase in the time to progression of the
disease, as measured by the EDSS, in patients with HLA-DR2 and/or HLA-DR4
immune response genes. It is estimated that up to 70% of all multiple
sclerosis patients are HLA-DR2 and/or HLA-DR4 positive(i). The EDSS is the
standard for measuring impairment in MS.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, progressive, often disabling
disease that attacks the central nervous system(ii). MS is caused by damage
to myelin, the protective sheath surrounding nerve fibers in the central
nervous system, resulting in disrupted nerve impulses traveling to and from
the brain and spinal cord(iii). Symptoms of MS may include vision
problems, loss of balance, numbness, difficulty walking and paralysis(iii,
iv).
MS is thought to affect as many as 2.5 million people worldwide,
including approximately 400,000 in the United States(v). It is a disease
that affects more women than men, with onset typically occurring between 20
and 50 years of age(v).
Approximately 30-40 percent of all MS patients have the secondary
progressive form of the disease(vi), in which irreversible disability
accumulates more steadily, with or without relapses(vii). There are few
treatment options available for these patients(viii).
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from
its own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind., Lilly
provides answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about Lilly is
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, dirucotide, is for the treatment of multiple sclerosis. In
December 2007, BioMS entered into a licensing and development agreement
granting Eli Lilly and Company exclusive worldwide rights to dirucotide in
exchange for an upfront payment, milestone payments and escalating
royalties on sales. For further information please visit our website at
This press release may contain forward-looking statements, which
reflect the current expectation of Lilly and BioMS 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. For
further discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission and
BioMS' filings with SEDAR. We undertake no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
(i) Wucherpfennig KW, Weiner HL, Hafler DA. T-cell recognition of
myelin basic protein. Immunology Today, 1991; 12: 277-282.
(ii) Ransohoff, R.M. Natalizumab for Multiple Sclerosis. New England
Journal of Medicine, 2007 Jun; 356; 25: 2622.
(iii) National Multiple Sclerosis Society. "Symptoms." Available at
sclerosis/symptoms/index.aspx. Accessed on 7.20.09
(iv) National Multiple Sclerosis Society. "What is MS?" Available at
services/LearnAboutMS/what-is-ms/index.aspx. Accessed on 7.20.09
(v) National Multiple Sclerosis Society. "Who gets MS? Patterns in the
multiple-sclerosis/who-gets-ms/index.aspx. Accessed on 7.20.09
(vi) Markowitz, C. Dirucotide (MBP8298) for the treatment of multiple
sclerosis. Therapy, 2008. 5(5): 1.
(vii) National Multiple Sclerosis Society. "Four Disease Courses of MS:
Secondary-Progressive MS (SPMS)." Available at
disease-courses-of-MS/index.aspx. Accessed on 7.20.09
(viii) Multiple Sclerosis Society. "Secondary Progressive Multiple
Sclerosis: How do you know when you have become
secondary progressive?" Available at
7.20.09
SOURCE: Eli Lilly and Company
CONTACT: Tony Hesby or Ryan Giese of BioMS Medical Corp.,
Office: +1-780-413-7152,
Fax: +1-780-408-3040,
E-mail: info@biomsmedical.com;
or David Shaffer,
Eli Lilly and Company,
Office: +1-317-651-3710,
Mobile: +1-317-614-5106,
E-mail: shaffer_david@lilly.com
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