Stromedix Secures Broad Patent Coverage for Lead Program
-- Company significantly expands patent estate adding broad coverage to important fibrosis target and prepares to initiate Phase 2 trial --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that the U.S. Patent Office has granted patent number US 7,465,449, which broadly covers monoclonal antibodies to integrin αvβ6, including compositions related to its lead product, STX-100. This patent provides Stromedix with strong intellectual property protection for antibody-based therapeutics directed against αvβ6 through at least 2023.
“The Stromedix team has made outstanding progress advancing our lead drug candidate STX-100”
“The Stromedix team has made outstanding progress advancing our lead drug candidate STX-100,” said Michael Gilman, Ph.D., Chief Executive Officer of Stromedix. “This corporate milestone and the recent completion of the Phase 1 clinical trial for STX-100 are significant achievements for our young company as we work to bring this potentially important new therapy to patients suffering from fibrotic organ failure. With the addition of this important patent to our existing αvβ6 intellectual property portfolio, we are well positioned to execute on this program.”
Stromedix holds a significant patent portfolio relating to development and commercialization of monoclonal antibodies to integrin αvβ6. The new patent covers high-affinity monoclonal antibodies and antigen-binding fragments that block the function of integrin αvβ6, which is an important regulator of fibrosis and tissue injury. It covers specific monoclonal antibody compositions including compositions relating to Stromedix’s lead drug candidate, STX-100. In addition it provides Stromedix with strong protection from potential competitors.
About STX-100
STX-100 is a humanized monoclonal antibody exclusively licensed in 2007 from Biogen Idec. This novel and proprietary compound targets integrin αvβ6, an important regulator of fibrosis and tissue injury. It exhibits significant anti-fibrotic activity in preclinical animal models of kidney, lung and liver disease. Stromedix recently completed a Phase 1 clinical trial of STX-100 and will initiate a Phase 2 trial in kidney transplant patients with interstitial fibrosis and tubular atrophy in early 2009. STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration.
About Fibrosis and Organ Failure
Fibrosis results from the body’s attempt to repair chronic tissue injury. Ongoing cycles of injury and repair, often playing out over decades, lead to accumulation of scar tissue in affected organs and disruption of normal tissue architecture and function. Ultimately the organ fails. Fibrosis is a final common pathway in virtually all forms of chronic organ failure, whether in kidney, liver, lung, or other organs, conditions affecting millions of patients in the United States. Moreover, the biology of fibrosis is similar regardless of cause – viral, chemical, physical or inflammatory. Fibrosis results from the excessive activity of fibroblasts, in particular a differentiated form known as the myofibroblast. The biology of these cells is well understood and there is consensus among experts that pharmacological attenuation of myofibroblast activity ought to slow or perhaps even reverse disease progression, thereby preserving organ function and prolonging healthy life.
About Stromedix
Stromedix, based in Cambridge, Massachusetts, is a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure. STX-100, Stromedix’s lead drug candidate, has completed a Phase 1 study and will enter Phase 2 testing in early 2009. Investors include Atlas Venture, New Leaf Venture Partners, Frazier Healthcare Ventures, Bessemer Venture Partners and Red Abbey Venture Partners. Biogen Idec is also a shareholder. For more information on Stromedix, please visit: www.stromedix.com.
