Insmed Releases Positive Results from IPLEX Phase II HIV-Associated Adipose Redistribution Syndrome Clinical Study



    RICHMOND, VA., April 30 /CNW/ - Insmed Inc., (Nasdaq:  INSM) today
announced positive results from a Phase II investigator-sponsored clinical
study of the company's drug IPLEX(TM) in HIV-infected patients affected with
HIV-associated Adipose Redistribution Syndrome (HARS).

    Preliminary results from the study, being conducted at the University of
California, San Francisco, showed that three months of 0.5 mg/kg/day IPLEX
treatment in seven patients increased IGF-I levels 3-fold and was associated
with significant improvements in fasting glucose levels, the amount of insulin
secreted during an oral glucose tolerance test, and overall insulin
sensitivity. Moreover, there was a significant reduction in trunk fat and a
positive downward trend in waist circumference when compared to baseline.
Lipid profiles also tended to improve.

    Notably, normal glucose tolerance was restored in half of the six
patients diagnosed with impaired glucose tolerance (IGT) at the start of the
study. These IGT patients also experienced a significant decrease in visceral
adipose tissue (VAT). Impaired glucose tolerance is characterized by blood
glucose between 140 and 200 mg/dl at the 120-minute measurement of an oral
glucose tolerance test. The next phase of the study is underway to explore an
IPLEX dose of 1.0 mg/kg/day given for six months.

    "Our study has demonstrated that a low dose of IPLEX increased IGF-I
levels 3-fold and positively impacted abnormal glucose metabolism, dyslipdemia
and abnormal fat distribution, which are present in a significant number of
HIV patients treated with highly active antiretroviral therapy (HAART)," said
Morris Schambelan, M.D., the study's principal investigator and professor of
medicine and director of the General Clinical Research Centers at University
of California, San Francisco, and chief of endocrinology at San Francisco
General Hospital.

    "We are very encouraged by these preliminary results with low-dose IPLEX.
We believe a product that improves fat distribution while also improving
insulin sensitivity would be a valuable therapy for this patient population,
and the positive effects on insulin sensitivity observed in this study are
consistent with what we observed in our previous studies with IPLEX in
patients with diabetes. These results support the most important
differentiating property of our product in this patient population, which is
IPLEX's ability to improve glucose homeostasis. Competitor products such as
TH9507 and growth hormone reportedly either do not alter glucose homeostasis
or exacerbate it, respectively. When considering that up to 40% of this
population has impaired glucose homeostasis, then this property of IPLEX
becomes even more valuable," said Dr. Geoffrey Allan, president and Chief
Executive Officer of Insmed.

    Study Description

    The ongoing, open-label, investigator-sponsored Phase II clinical study
is designed to evaluate the safety and efficacy of IPLEX in two cohorts of
subjects, the first of which received a 0.5 mg/kg/day dose and the second of
which will receive 1.0 mg/kg/day dose. The primary endpoints of the study are
to determine the safety and tolerability of IPLEX and its effects on visceral
fat and insulin sensitivity.

    About HARS

    An estimated 80,000 HIV patients in the U.S. have HARS, according to
published reports. This disorder is marked by abnormal metabolism, including
central fat accumulation (visceral adiposity and buffalo hump) with or without
fat loss in the limbs. These features have increased markedly with the advent
of highly active antiretroviral therapy (HAART) for HIV. Recent studies
performed in subjects on HAART suggest nearly 40% of individuals develop the
morphologic features characteristic of this syndrome.

    About IPLEX

    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) is 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 myotonic
muscular dystrophy, retinopathy of prematurity and amyotrophic lateral
sclerosis (also known as ALS or Lou Gehrig's disease).

    About the University of California, San Francisco

    The University of California, San Francisco (UCSF), is a leading
university that consistently defines health care worldwide by conducting
advanced biomedical research and providing leading life science education and
complex patient care. For more information, please visit www.ucsf.com.

    About Insmed

    Insmed is a biopharmaceutical company focused on the development and
commercialization of drugs for the treatment of metabolic diseases and
endocrine disorders with unmet medical needs. For more information, please
visit www.insmed.com.

    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.




For further information:

For further information: Investor Relations International Haris Tajyar,
818-382-9702 htajyar@irintl.com

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