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Tuesday, June 26, 2007 9:27:50 AM
BusinessWire 9:15 am June 26, 2007
RICHMOND, Va.--(BUSINESS WIRE)--
Insmed Incorporated (Nasdaq:INSM), a biopharmaceutical companyfocused on the development and approval of drugs for the treatment ofmetabolic diseases with unmet medical needs, today noted thepublication of promising results of research from three universitiesregarding the potential role of insulin-like growth factor bindingprotein-3 (IGFBP-3) in the prevention of blindness among prematureinfants.
IGFBP-3 is a key component of Insmed's lead drug candidate,IPLEX(TM), which has been approved by the U.S. Food and DrugAdministration for the treatment of a severe growth disorder and iscurrently being studied as a treatment for myotonic musculardystrophy, HIV-associated adipose redistribution syndrome andretinopathy of prematurity (ROP). IPLEX(TM) is the combination ofIGFBP-3 with recombinant human insulin-like growth factor 1 (IGF-I).
The new study results, published in the June 19 issue of theProceedings of the National Academy of Sciences, focus on the actionof IGFBP-3 in promoting normal tissue growth and preventing ROP.Researchers at the University of Florida reported that mice treatedwith IGFBP-3 showed closer-to-normal growth of retinal vasculaturethan mice without IGFBP-3 in similar high-oxygen conditions.Researchers at Harvard Medical School and the University of Goteborgin Sweden reported similar results.
In addition, Harvard Medical School researchers, in collaborationwith researchers at the University of Goteborg, reported results of aclinical study showing IGFBP-3 levels in infants with ROP were lowerthan those of healthy babies. The researchers said these resultssuggest that IGFBP-3, acting independently of IGF-I, helps preventoxygen-induced loss of blood-vessels and helps promote vascularre-growth.
Insmed Chairman and CEO Geoffrey Allan, Ph.D., commented: "Thesestudies by researchers at three distinguished universities mark animportant scientific milestone in Insmed's development of IPLEX(TM) asa treatment for ROP. They suggest that IGFBP-3, once thought only toregulate IGF-I, actually plays a broader role in human development andin the growth or regeneration of human tissues. Not only is thisdiscovery important in the fight against ROP, but it also suggestspromising avenues for research into the treatment of other conditionsassociated with ischemia and vascular damage."
About IPLEX(TM) and ROP
IPLEX(TM) is currently in the first phase of clinical developmentfor the treatment of ROP, a disease that affects an estimated 14,000to 16,000 premature infants each year. ROP impedes the development ofthe small blood vessels in the back of the eye, leading to blindnessin severe cases. A Phase I clinical study investigating IPLEX(TM) as atreatment for ROP is underway at the University of Goteborg, incollaboration with scientists at the Harvard Medical School. Tenpatients will be enrolled with the objective of the study being todetermine the dose of IPLEX(TM) required to increase serum IGF-Ilevels into the normal physiological range. This study is expected tobe completed by the end of 2007.
About Insmed
Insmed is a biopharmaceutical company focused on the developmentand approval of drugs for the treatment of metabolic diseases withunmet medical needs. For more information, please visitwww.insmed.com. To be added to Insmed's investor lists, please contactHaris Tajyar at htajyar@irintl.com or at 818-382-9702.
Forward Looking Statements
This release contains forward-looking statements which are madepursuant to provisions of Section 21E of the Securities Exchange Actof 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 managementand growth opportunities for existing or proposed products, constituteforward-looking statements which involve risks and uncertainties thatcould cause actual results to differ materially from those anticipatedby the forward-looking statements. The risks and uncertaintiesinclude, without limitation, risks that product candidates may fail inthe clinic or may not be successfully marketed or manufactured, theCompany may lack financial resources to complete development ofproduct candidates, the FDA may interpret the results of studiesdifferently than the Company, competing products may be moresuccessful, demand for new pharmaceutical products may decrease, thebiopharmaceutical industry may experience negative market trends andother risks and challenges detailed in the Company's filings with theU.S. Securities and Exchange Commission, including the Company'sQuarterly Report on Form 10-Q for the quarter ended March 31, 2007.Readers are cautioned not to place undue reliance on anyforward-looking statements which speak only as of the date of thisrelease. The Company undertakes no obligation to publicly release theresults of any revisions to these forward-looking statements that maybe made to reflect events or circumstances that occur after the dateof this release or to reflect the occurrence of unanticipated events.
Source: Insmed
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