Insmed Announces Results of IPLEX(TM) Phase II Trial in Myotonic Muscular Dystrophy
25 Juin 2009 - 2:00PM
PR Newswire (US)
- Insmed to Evaluate Potential Initiation of Phase II Trial for
IPLEX(TM) in MMD Patients with Severe Insulin Resistance -
RICHMOND, Va., June 25 /PRNewswire-FirstCall/ -- Insmed Inc.
(NASDAQ: INSM), a biopharmaceutical company, today announced
results from its exploratory U.S. Phase II clinical trial
evaluating IPLEX(TM) (mecasermin rinfabate) in patients with
myotonic muscular dystrophy ("MMD"). The randomized, double-blind,
placebo-controlled Phase II trial conducted in 13 centers across
the U.S. enrolled 69 patients with MMD, for a six-month period. As
this was an exploratory trial, a primary endpoint was not
pre-defined. The trial explored measures of endurance, using the
six-minute walk test, muscle function and strength, cognitive
function, gastrointestinal function, pain, quality of life, insulin
sensitivity, lipid metabolism, and safety and tolerability of
IPLEX(TM). The results of the trial indicated that IPLEX(TM) did
not exhibit a statistically significant improvement in the
functional measure of endurance by the six-minute walk test, muscle
function, muscle strength, or quality of life in any of the tests
utilized in this study. Based on the limited number of subjects
enrolled with significant impairments in cognitive function,
gastrointestinal function or pain, Insmed was unable to reach any
conclusions regarding the effects of IPLEX(TM) on these endpoints.
IPLEX(TM) did, however, demonstrate improvements in standard
measures of insulin sensitivity and reductions in fasting glucose,
fasting insulin, cholesterol and triglycerides, which is consistent
with the expected metabolic profile of insulin-like growth factor.
Administration of IPLEX(TM) also resulted in anabolic effects of
increased body mass index and higher levels of testosterone. The
drug was well tolerated in MMD subjects and demonstrated a safety
profile consistent with previous studies of IPLEX(TM). Based on the
metabolic improvements observed in patients treated with IPLEX(TM)
in this trial, and discussions with key opinion leaders, the
Company intends to apply for a grant from the Muscular Dystrophy
Association ("MDA") to facilitate an additional Phase II trial
focused solely on a subset of MMD patients with severe insulin
resistance who, based on the results of this trial, may be more
likely to benefit from IPLEX(TM) treatment. Alternative methods of
assessing muscle function will be considered for the proposed
trial. Dr. Melvin Sharoky, Insmed's Chairman, commented, "We are
disappointed that this trial did not meet the majority of its
functional endpoints. However, the statistically significant
improvement in insulin sensitivity seen in this study suggests that
an additional phase II study in MMD patients with severe insulin
resistance may be warranted. We appreciate the MDA's financial
support for the completed trial and look forward to the possibility
of continuing to work with them." Sharon Hesterlee, Senior Vice
President and Executive Director of MDA Venture Philanthropy, said,
"While the phase II clinical trial of IPLEX(TM) did not show
efficacy in the overall MMD population in this trial, based on the
data generated, we look forward to evaluating Insmed's grant
application for a possible Phase II trial aimed at MMD patients
with severe insulin resistance." Dr. Sharoky continued, "IPLEX(TM)
continues to demonstrate a strong safety profile and we believe it
offers a potential treatment in multiple therapeutic areas,
including Amyotrophic Lateral Sclerosis. Beyond IPLEX(TM), our
current cash reserves of approximately $120 million provides us
with a significant opportunity to continue growing our business
through a variety of potential business development initiatives. We
look forward to continuing to explore these possibilities with our
strategic financial advisor, RBC Capital Markets." About Myotonic
Muscular Dystrophy Myotonic muscular dystrophy is a genetic
disorder resulting in a highly variable presentation of symptoms
across multiple body systems. The most prevalent symptoms include
progressive muscular weakness and myotonia, cardiac arrhythmias,
cognitive defects, cataracts, as well as well as endocrine, sexual,
gastrointestinal and reproductive disturbances. There is currently
no cure for the disease, which affects approximately 37,000
individuals in the U.S., and no specific treatment has been
discovered to satisfactorily reverse or ameliorate the common
symptoms associated with the disease. For more information on MMD,
please visit http://www.mda.org/. About Insmed Insmed Inc. is a
biopharmaceutical company with unique protein development
experience and a proprietary protein platform aimed at niche
markets with unmet medical needs. For more information, please
visit http://www.insmed.com/. Forward-Looking Statements This
release contains forward-looking statements which are made pursuant
to provisions of Section 21E of the Securities Exchange Act of
1934. Investors are cautioned that such statements in this release,
including statements relating to an additional phase II trial,
constitute forward-looking statements which involve risks and
uncertainties that could cause actual results to differ materially
from those anticipated by the forward-looking statements. The risks
and uncertainties include, without limitation, Insmed may not apply
for or receive a grant for an additional phase II trial, the FDA
may interpret the results of studies differently than us, product
candidates may fail in the clinic or may not be successfully
marketed or manufactured, competing products may be more
successful, our continuing efforts to grow the business and develop
IPLEX(TM) may be unsuccessful , we may lack financial resources to
complete development of product candidates, we may be unsuccessful
in finding or pursuing business development initiatives, and other
risks and challenges detailed in our filings with the U.S.
Securities and Exchange Commission, including our Annual Report on
Form 10-K for the year ended December 31, 2008. Readers are
cautioned not to place undue reliance on any forward-looking
statements which speak only as of the date of this release. We
undertake no obligation to publicly release the results of any
revisions to these forward-looking statements that may be made to
reflect events or circumstances that occur after the date of this
release or to reflect the occurrence of unanticipated events.
Investor Relations Contact: Brian Ritchie - FD 212-850-5683 Media
Relations Contact: Irma Gomez-Dib - FD 212-850-5761 DATASOURCE:
Insmed Inc. CONTACT: Investor Relations: Brian Ritchie,
+1-212-850-5683, , or Media Relations: Irma Gomez-Dib,
+1-212-850-5761, , both of FD Web Site: http://www.insmed.com/
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