Replies to post #105182 on Naz News, Gappers and FLE''s

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Insmed Announces Promising Results From IPLEX Phase II Myotonic Muscular Dystrophy Clinical Study




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Thu May 03 09:16:47 2007 EDT
RICHMOND, VA., May 3, 2007 (Canada NewsWire via COMTEX News Network) --
Insmed Inc. (Nasdaq:INSM) today announced positive results from a Phase II investigator-sponsored
study of the company's drug, IPLEX(TM), in patients with myotonic muscular dystrophy
(DM1).
Preliminary results of the clinical study, being conducted at the University
of Rochester School of Medicine and Dentistry, showed that six months of treatment
with doses of IPLEX up to 1 mg/kg/day in six patients met the primary study endpoints
of being safe and well tolerated. In addition, IPLEX treatment was associated with
improvements in muscle mass, cholesterol and triglycerides. During the six months
of treatment, 5 out of 6 patients experienced an improvement in lean muscle mass.
Patients also reported improvement in gastrointestinal function, endurance and cognitive
function during treatment with IPLEX.
"We are very encouraged by the results from this preliminary study of IPLEX
in myotonic dystrophy. The results not only indicate IPLEX was safe, well tolerated
and had a positive effect on muscle and lipid metabolism, they also suggest IPLEX
may have a positive effect on aspects of the disease that affect patients' daily
living," said Dr. Geoffrey Allan, president and CEO of Insmed.
Study Description
The primary objectives of this ongoing open-label, Phase II dose escalation
study are to examine the safety and tolerability of once-daily, subcutaneous injection
of IPLEX in up to 15 patients with DM1 and to identify the maximum tolerated dose.
The next cohort of patients will be treated for six months with a dose of IPLEX
which will be titrated up to 2 mg/kg/day.
The study is funded by the National Institutes of Health and the Muscular
Dystrophy Association, with supply of IPLEX drug provided by Insmed. A Phase II,
placebo-controlled study to further investigate the safety and efficacy of IPLEX
in a larger number of patients with DM1 is being designed based on the preliminary
results of this study.
About Myotonic Muscular Dystrophy
Myotonic muscular dystrophy, also known as myotonic dystrophy, dystrophia
myotonica or Steinert's disease, is the most common type of adult muscular dystrophy,
affecting 1 in 8000 individuals (approximately 40,000 people in the United States).
Myotonic dystrophy patients develop progressive muscle wasting and weakness in the
hands, forearms, legs, neck and face, as well as cataracts and cardiac arrhythmias,
and eventually can become totally disabled, dying usually from respiratory or cardiac
failure. At present, there is no treatment to reverse most of these symptoms. For
more information about myotonic muscular dystrophy, please visit www.mda.org.
About IPLEX(TM)
IPLEX was approved in the United States in December 2005 for the treatment
of children with growth failure due to severe primary IGF-I deficiency (Primary
IGFD). IPLEX (rhIGF-I/rhIGFBP-3), a complex of recombinant human insulin-like growth
factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The
drug is also being investigated for various other indications with unmet medical
needs, including HIV-associated adipose redistribution syndrome, retinopathy of
prematurity and amyotrophic lateral sclerosis (otherwise known as ALS or Lou Gehrig's
disease).
About Insmed
Insmed is a biopharmaceutical company focused on the development and commercialization
of drugs for the treatment of metabolic diseases with unmet medical needs. For more
information, please visit www.insmed.com.
About the University of Rochester School of Medicine and Dentistry
The University of Rochester School of Medicine and Dentistry is a leading
medical university that consistently defines health care worldwide by conducting
advanced biomedical research and providing leading life science education and complex
patient care. It has been designated by the National Institutes of Health (NIH)
as one of several "centers of excellence" for muscular dystrophy research and is
receiving up to $1 million per year for five years in federal NIH funding and up
to $500,000 per year for three years from MDA, for a total of up to $6.5 million,
to identify potential muscular dystrophy therapies. For more information, please
visit www.urmc.rochester.edu.
About The Muscular Dystrophy Association
The Muscular Dystrophy Association (MDA) is a voluntary health agency --
a dedicated partnership between scientists and concerned citizens aimed at conquering
neuromuscular diseases that affect more than a million Americans. MDA combats neuromuscular
diseases through programs of worldwide research, comprehensive medical and community
services, and far-reaching professional and public health education. MDA is the
world's largest non-governmental sponsor of research seeking the causes of and effective
treatments for neuromuscular diseases, sponsoring some 400 research projects annually.
For more information, please visit www.mda.org.
Forward Looking Statements
Statements included within this press release, which are not historical in
nature, may constitute forward-looking statements for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. Forward-looking
statements in this press release include, but are not limited to, statements regarding
planned clinical study design, our regulatory and business strategies, plans and
objectives of management and growth opportunities for existing or proposed products.
Such forward-looking statements are subject to numerous risks and uncertainties,
including risks that product candidates may fail in the clinic or may not be successfully
marketed or manufactured, the company may lack financial resources to complete development
of product candidates, the FDA may interpret the results of our studies differently
than we have, competing products may be more successful, demand for new pharmaceutical
products may decrease, the biopharmaceutical industry may experience negative market
trends and other risks detailed from time to time in the company's filings with
the Securities and Exchange Commission. As a result of these and other risks and
uncertainties, actual results may differ materially from those described in this
press release. For further information with respect to factors that could cause
actual results to differ from expectations, reference is made to reports filed by
the Company with the Securities and Exchange Commission under the Securities Exchange
Act of 1934, as amended. The forward-looking statements made in this release are
made only as of the date hereof and Insmed disclaims any intention or responsibility
for updating predictions or financial guidance contained in this release.
SOURCE: Insmed Inc.
Investor Relations International Haris Tajyar, 818-382-9702 [e-mail]


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