Pro-Pharmaceuticals Prepares Phase III DAVANAT(R) Trial For Second Half 2010
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Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), the stellar developer of therapeutics that prey Galectin receptors to dainty cancer and fibrosis, proclaimed plans to posit a Phase III tryout designing for DAVANAT® to the U.S. Food and Drug Administration (FDA) during the secondment one-half of 2010. The Company has added the gift of Peter G. Traber, M.D., to its FDA commendation scheme and visitation excogitation squad. Dr. Traber is a well-thought-of investigator, aesculapian, regulative and clinical technical, and serves on the Company’s Board of Directors.
“Dr. Traber brings to the Pro-Pharmaceuticals squad years of successful see in dose growth and approving. He has gained a thoroughgoing savvy of our test results and our products,” aforementioned Theodore D. Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. “We consider Dr. Traber to be a worthful plus in producing a comp Phase III innovation with a greater chance of a successful FDA blessing.”
One scheme Dr. Traber and Pro-Pharmaceuticals may engage includes a Special Protocol Assessment (SPA), which, if successful, involves correspondence in approach from the FDA that a Phase III run’s designing, clinical endpoints, and statistical analyses are satisfactory for FDA approving.
“I think that DAVANAT® bequeath be a game-changer in cancer discourse, and I am look forrader to providing hands-on accompaniment to Pro-Pharmaceuticals as we designing the Phase III tryout for DAVANAT®,” aforesaid Dr. Traber. “We contrive to take the tribulation conception to the FDA during the arcsecond one-half of 2010 as we go toward the end of commercializing DAVANAT®.”
Dr. Traber was elective to Pro-Pharmaceuticals’ Board of Directors in 2009. He is President Emeritus and old Chief Executive Officer of Baylor College of Medicine. Dr. Traber presently is Chair of the Board and Chief Executive Officer of TerraSep, LLC, a Mountain View, CA ergonomics accompany. Previously, Dr. Traber was Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer of GlaxoSmithKline. He has too served as Chief Executive Officer of the University of Pennsylvania Health System, as easily as Chair of the Department of Internal Medicine and Chief of Gastroenterology for the University of Pennsylvania School of Medicine.
DAVANAT®, the Company’s track intersection nominee, is a polyose polymer that targets Galectin receptors, which peer-reviewed studies let demonstrated gambol authoritative enabling roles in cancer, including tumour cellphone selection, angiogenesis, tumour metastasis and tumour invisibleness to the resistant organization. To engagement, DAVANAT® has been administered to roughly 100 cancer patients. Data from a Phase II tryout for end-stage colorectal cancer patients showed that DAVANAT® in combining with 5-FU extensive medial selection 46% yearner than the outdo stock of upkeep as driven by the patients’ physicians. Clinical run results besides showed that patients experient well fewer good contrary position effects from the chemotherapy including 100% riddance of sores in the lip and end-to-end the colon, resulting in less hospitalisation, and greatly enhanced character of biography.
Pro-Pharmaceuticals, Inc.
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