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SomatoKine(R) Pivotal Data to Be Featured in a Podium Presentation at the ESPE/LWPES 7th Joint Meeting of Pediatric Endocriniology in Lyon, France.


RICHMOND, Va. -- Insmed Incorporated (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: 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 growth hormone insensitivity syndrome Laron dwarfism, pituitary dwarfism II An AR condition characterized by severe growth retardation, delayed bone age, occasionally blue sclerae, and physical manifestations of GH deficiency, due to a defect in the GH receptor  (GHIS), will be featured in a podium presentation on Friday, September 23 at the European Society Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 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 anabolic

pertaining to or arising from anabolism.


anabolic steroid
steroids with a tissue-building effect. Testosterone is an example of a natural anabolic steroid with the, sometimes undesirable, effect of causing masculinization.
 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 IGF-I

see somatomedin C.

IGF-I Insulin-like growth factor I, somatomedin-C A polypeptide hormone structurally similar to proinsulin, synthesized in the liver and fibroblasts, giving fibroblasts a paracrine function; serum levels correlate with
 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 insulin-like growth factor

one of the twenty or so substances, additional to the classic bone-regulating hormones, which exert an effect on bone cell metabolism. See also somatomedin C.
 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 The Insulin-like growth factor binding protein serves as a carrier protein for Insulin-like growth factor 1.

Approximately 98% of IGF-1 is always bound to one of 6 binding proteins (IGF-BP). IGFBP-3, the most abundant protein, accounts for 80% of all IGF binding.
 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 type 2 diabetes
n.
See diabetes mellitus.
, 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 bone mineral density
n.
See bone density.


bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry.
. In addition to the GHIS program, SomatoKine is currently being studied in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 at the University of California, San Francisco Coordinates:   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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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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Publication:Business Wire
Geographic Code:1USA
Date:Sep 19, 2005
Words:680
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