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RICHMOND, Va., April 26, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Incorporated (Nasdaq: INSM) announced today that preliminary data from a prospective, multicenter clinical trial using rhIGF-I/rhIGFBP-3 (IPLEX) administered once daily to children with Severe Primary IGF-1 deficiency will be presented during a podium presentation at the Pediatric Academic Societies' (PAS) 2006 Annual Meeting. The meeting is being held from April 29 - May 2 at the Moscone Center in San Francisco, Calif.
The presentation, entitled rhIGF-I/rhIGFBP-3 (IPLEX) Administered Once Daily in Children with IGF-I Deficiency Due to Growth Hormone Insensitivity: Preliminary Data from a Prospective, Multicenter Clinical Trial, will be presented by Kenneth M. Attie, MD.
The presentation will highlight the 12 month Height Velocity data from once daily treatment with IPLEX (rhIGF-I/rhIGFBP-3) in children with Severe Primary IGF-I deficiency. Treatment with IPLEX demonstrated statistically significant, dose dependent increases in Height Velocity with a favorable safety profile. The presentation will take place as part of PAS on Monday, May 1 at 10:45 a.m. PT, Room 3007-3011, Moscone West.
IPLEX, a complex of rhIGF-1 and rhIGFBP-3, is the only once-daily IGF-1 replacement therapy and the only therapy that provides both IGF-1 and IGFBP-3 that is approved by the FDA to treat children with severe Primary IGFD. The drug, expected to launch during the second quarter of calendar year 2006, is also being studied for various other indications with unmet medical needs including extreme insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS).
About the Condition
Severe Primary IGFD is a genetic condition in which patients do not generate sufficient quantities of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3), two key proteins involved in mediating the effects of growth hormone. Patients with severe Primary IGFD present with extreme short stature (height standard deviation score, SDS
About Insmed Incorporated
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, 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 trial 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.