Insmed Initiates Phase II HIV-Associated Lipodystrophy Trial With Somatokine(R)
20 Avril 2005 - 3:01PM
PR Newswire (US)
Insmed Initiates Phase II HIV-Associated Lipodystrophy Trial With
Somatokine(R) RICHMOND, Va., April 20 /PRNewswire-FirstCall/ --
Insmed Incorporated (NASDAQ:INSM) today announced that it has
initiated a Phase II clinical trial examining the therapeutic
benefit of treating HIV-Associated Lipodystrophy with
SomatoKine(R), the Company's proprietary once daily IGF-I therapy.
The Phase II clinical trial, led by Principal Investigator Dr.
Morris Schambelan, Professor of Medicine at UC San Francisco and
Chief of Endocrinology and Director of the General Clinical
Research Center San Francisco General Hospital, is an open-label
study designed to evaluate the safety and efficacy of SomatoKine
for 12 weeks in 12 subjects with HIV associated lipodystrophy. To
qualify for inclusion in the study, patients must be between 18-65
years of age, have confirmed HIV-1 infection, fat accumulation
(visceral adiposity), and evidence of insulin resistance. The
primary goal of the study is to determine the effects of SomatoKine
on visceral fat and insulin sensitivity. "We have made tremendous
strides in treating HIV infection with highly active antiretroviral
therapy. However, with these advances, we have encountered a number
of troublesome side effects, including insulin resistance and
abnormalities in fat distribution. We are eager to identify
effective therapies for these problems, so that affected patients
may return to a more normal metabolic state. In previous studies,
SomatoKine has demonstrated an ability to improve both insulin
sensitivity and body composition in other patient populations, and
we are optimistic that those benefits will be seen in our HIV
positive patients as well," stated Dr. Schambelan. More on
HIV-Associated Lipodystrophy Since the advent of highly active
antiretroviral therapy (HAART), there has been a marked increase in
adverse metabolic effects, such as insulin resistance,
hyperglycemia, dyslipidemia and changes in body fat distribution
that include syndromes of both central fat accumulation (visceral
adiposity and buffalo hump) and fat loss in the limbs. Recent
studies performed in subjects on HAART suggest nearly 50% of
individuals develop the morphologic features of this syndrome. With
the similarity to metabolic syndrome X, which has been associated
with increased risk of cardiovascular disease, it is now feared
that these side effects may impact on the long-term prognosis in
patients whose life expectancies have been significantly extended
due to effective viral suppression by HAART. More on
rhIGF-I/rhIGFBP-3, SomatoKine(R) Insmed's SomatoKine is a
proprietary drug product of insulin-like growth factor-I (IGF-I)
and its principal binding protein, IGFBP-3. The novel compound is
administered as a single daily subcutaneous injection, capable of
restoring IGF-I levels into the normal range in deficient
individuals. On 10 March 2005, Insmed announced that the FDA had
accepted Insmed's NDA submission for SomatoKine for the treatment
of children with Growth Hormone Insensitivity Syndrome (GHIS), and
on April 13, 2005 the Company announced that the FDA had granted
the GHIS NDA submission Priority Review status. In phase II studies
in diabetic subjects, SomatoKine treatment resulted in improved
blood glucose control and reduced daily insulin use. In studies in
children and adults with severe burn injury, SomatoKine treatment
resulted in increased muscle protein synthesis and reduced
inflammatory response. In studies in elderly subjects recovering
from hip fracture, SomatoKine treatment resulted in improved
functional activity and preserved bone mineral density. About
Insmed Insmed is a biopharmaceutical company focused on the
discovery and development of drug candidates for the treatment of
metabolic diseases and endocrine disorders with unmet medical
needs. For more information, please visit http://www.insmed.com/ .
Statements included within this press release that are not
historical in nature may constitute forward-looking statements for
purposes of the safe harbour 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
clinical trials and goals, our regulatory and business strategies
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.
DATASOURCE: Insmed Incorporated CONTACT: Baxter Phillips, III of
Insmed Incorporated, Investor Relations, +1-804-565-3041, or fax,
+1-804-565-3510, or Web site: http://www.insmed.com/
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