SomatoKine(R) Pivotal Data to Be Featured in a Podium Presentation at the ESPE/LWPES 7th Joint Meeting of Pediatric Endocriniolo
19 Septembre 2005 - 3:42PM
Business Wire
Insmed Incorporated (NASDAQ: INSM) today announced that data from
the Company's New Drug Application for Somatokine
(rhIGF-I/rhIGFBP-3) (mecasermin rinfibate) for the treatment of
Growth Hormone Insensitivity Syndrome (GHIS), will be featured in a
podium presentation on Friday, September 23 at the European Society
Pediatric Endocrinology/ Lawson Wilkins Pediatric Endocrine Society
7th Joint Meeting, a global meeting of pediatric endocrinologists
occurring every four years. During the Conference Symposium titled,
"Update on Growth and Anabolic Therapies", Cecelia Camacho-Hubner,
M.D., of St. Bartholemew's Hospital, London, United Kingdom will
give the lecture featuring long-term safety and efficacy of the
once-daily IGF-I replacement therapy, SomatoKine, in children with
GHIS. About GHIS GHIS encompasses a variety of genetic and acquired
conditions in which the action of growth hormone (GH) is absent or
severely attenuated, resulting in low serum levels of IGF-I.
Because IGF-I is the primary mediator of the growth-promoting
actions of GH, SomatoKine replacement therapy in children with GHIS
is intended to bypass the blocked actions of GH by replacing the
deficient IGF-I, resulting in improved growth. More on SomatoKine
Insmed's SomatoKine is a proprietary drug product for the delivery
of recombinant insulin-like growth factor I (IGF-I). It is
administered as a preformed complex with a recombinant form of its
natural binding protein, insulin-like growth factor binding protein
3 (rhIGFBP-3). The novel compound is administered as a once-daily
subcutaneous injection, which can restore and maintain IGF-I levels
to physiologically relevant levels. The binding protein (rhIGFBP-3)
extends the residence time of IGF-I in the blood, conferring a
superior pharmacokinetic profile as compared with rhIGF-I alone. In
the bound state, the IGF-I is inactive, and remains so until
delivered to target tissues in the body where it is released and
becomes biologically active. This reduces the risk of short- and
long-term safety concerns that have been associated with
unrestrained levels of free IGF-I. SomatoKine has been investigated
in a number of other indications in addition to growth disorders.
In patients with Type 1 and Type 2 diabetes, administration of
SomatoKine demonstrated a significant improvement in blood sugar
control and a significant reduction in daily insulin use. In
children and adults suffering severe burn injury, administration of
SomatoKine demonstrated a significant improvement in muscle protein
synthesis and a significant reduction in the inflammatory response
associated with the trauma. In elderly individuals recovering from
hip fractures, administration of SomatoKine demonstrated a
significant improvement in functional recovery and bone mineral
density. In addition to the GHIS program, SomatoKine is currently
being studied in a Phase II clinical trial at the University of
California, San Francisco in patients with HIV-Associated
Lipodystrophy, and in a Phase II clinical trial at the University
of Cambridge, U.K. in patients with Extreme Insulin Resistance.
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. For more information,
please visit www.insmed.com. 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 include all statements regarding
expected financial position, results of operations, cash flows,
dividends, financing plans, business strategies, operating
efficiencies or synergies, budgets, capital and other expenditures,
competitive positions, growth opportunities for existing or
proposed products or services, plans and objectives of management,
demand for new pharmaceutical products, market trends in the
pharmaceutical business, inflation and various economic and
business trends. 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, the company may lack financial resources to complete
development of product candidates, 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.
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