IGFBP-3 is a key component of Insmed's lead drug candidate, IPLEX(TM), which has been approved by the U.S. Food and Drug Administration for the treatment of a severe growth disorder and is currently being studied as a treatment for myotonic muscular dystrophy, HIV-associated adipose redistribution syndrome and retinopathy of prematurity (ROP). IPLEX(TM) is the combination of IGFBP-3 with recombinant human insulin-like growth factor 1 (IGF-I).
The new study results, published in the June 19 issue of the Proceedings of the National Academy of Sciences, focus on the action of IGFBP-3 in promoting normal tissue growth and preventing ROP. Researchers at the University of Florida reported that mice treated with IGFBP-3 showed closer-to-normal growth of retinal vasculature than mice without IGFBP-3 in similar high-oxygen conditions. Researchers at Harvard Medical School and the University of Goteborg in Sweden reported similar results.
In addition, Harvard Medical School researchers, in collaboration with researchers at the University of Goteborg, reported results of a clinical study showing IGFBP-3 levels in infants with ROP were lower than those of healthy babies. The researchers said these results suggest that IGFBP-3, acting independently of IGF-I, helps prevent oxygen-induced loss of blood-vessels and helps promote vascular re-growth.
Insmed Chairman and CEO Geoffrey Allan, Ph.D., commented: "These studies by researchers at three distinguished univ ersities mark an important scientific milestone in Insmed's development of IPLEX(TM) as a treatment for ROP. They suggest that IGFBP-3, once thought only to regulate IGF-I, actually plays a broader role in human development and in the growth or regeneration of human tissues. Not only is this discovery important in the fight against ROP, but it also suggests promising avenues for research into the treatment of other conditions associated with ischemia and vascular damage."
About IPLEX(TM) and ROP
IPLEX(TM) is currently in the first phase of clinical development for the treatment of ROP, a disease that affects an estimated 14,000 to 16,000 premature infants each year. ROP impedes the development of the small blood vessels in the back of the eye, leading to blindness in severe cases. A Phase I clinical study investigating IPLEX(TM) as a treatment for ROP is underway at the University of Goteborg, in collaboration with scientists at the Harvard Medical School. Ten patients will be enrolled with the objective of the study being to determine the dose of IPLEX(TM) required to increase serum IGF-I levels into the normal physiological range. This study is expected to be completed by the end of 2007.
Insmed is a biopharmaceutical company focused on the development and approval of drugs for the treatment of metabolic diseases with unmet medical needs. For more information, please visit www.insmed.com. To be added to Insmed's investor lists, please contact Haris Tajyar at firstname.lastname@example.org or at 818-382-9702.
Forward Looking Statements
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed produ cts, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, 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 studies differently than the Company, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
Investor Relations International
Haris Tajyar, 818-382-9702