(BUSINESS WIRE)--Insmed Incorporated 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. Our approach is to correct metabolic defects in the human body by replacing key regulatory molecules in a physiologically relevant fashion. We believe this approach will translate into an intrinsic safety advantage for our products in the marketplace. We currently have two product candidates in active internal development, rhIGF-I/rhIGFBP-3 and rhIGFBP-3.
rhIGF-I/rhIGFBP-3 is a novel delivery composition of IGF-I that regulates essential metabolic and anabolic (growth promoting) processes, including glucose uptake and tissue regeneration. rhIGF-I/rhIGFBP-3 is currently in clinical development for growth hormone insensitivity syndrome (GHIS) and both type 1 and type 2 diabetes. We have recieved Orphan Drug Designation for rhIGF-I/rhIGFBP-3 from the FDA and the EMEA in GHIS. We initiated a pivotal Phase III clinical trial in this disorder in June 2003. We expect to file for marketing approval for GHIS in 2004.
rhIGFBP-3 is a biotherapeutic that we are developing as an anti-tumor agent. Preclinical studies have demonstrated that rhIGFBP-3 enhances "standard of care" therapy and has shown comparable efficacy as a sole treatment against cancer in animal models. As a naturally occurring compound, rhIGFBP-3 may not elicit the undesirable side effects characteristic of cancer therapies on the market today. We expect to initiate clinical trials with rhIGFBP-3 in the first half of 2004. We are actively seeking strategic partnerships to develop this compound.