�Stromedix, Inc., a ergonomics company focused on innovational therapies for fibrosis and fibrotic organ failure, announced today that its pencil lead clinical prospect STX-100 has been granted orphan drug status by the US Food and Drug Administration ("FDA") for the treatment of chronic allograft renal disorder. Chronic allograft nephropathy (CAN), also known as chronic allograft dysfunction, is a fibrotic shape that is a leading cause of kidney graft failure. Approximately 20% of patients on the wait list for kidney transplantation in the United States are awaiting a retransplant of a failed transplant. There are no FDA-approved therapies for CAN.
STX-100 is a novel humanized monoclonal antibody licensed in 2007 from Biogen Idec. STX-100 targets integrin ?v?6 and exhibits significant anti-fibrotic activity in preclinical animal models of kidney, lung and liver disease. Stromedix initiated a Phase 1 clinical trial of STX-100 in early 2008.
Orphan do drugs status confers seven geezerhood of market exclusivity following FDA approval as well as certain tax advantages to companies that charter on the challenge of developing lifesaving drugs for small affected role populations.
"There is a clear medical need for therapies that prolong graft function in kidney transplant patients and that more than broadly stamp down fibrosis in other clinical settings," aforementioned Michael Gilman, Ph.D., CEO of Stromedix. "We have made rapid progress on STX-100 since obtaining the program from Biogen Idec last year. This activity by the FDA should facilitate the development of this dose for transplant patients."
About Stromedix
Stromedix, based in Cambridge, Massachusetts, is a biotechnology company focused on innovative therapies for fibrotic organ failure. Stromedix' investors include Atlas Venture, New Leaf Venture Partners, Frazier Healthcare Ventures, Bessemer Venture Partners and Red Abbey Venture Partners. Biogen Idec is besides a shareholder.
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