BUFFALO, N.Y., Jan. 18, 2011 /PRNewswire/ -- CureFAKtor Pharmaceuticals, LLC, a privately-held biopharmaceutical company focused on the research and development of Focal Adhesion Kinase (FAK) inhibitors for cancer, today announced that its lead compound, CFAK-C4 , which is in development for the treatment of pancreatic cancer, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S.
Orphan Drug Designation provides for a number of potential incentives related to CFAK-C4, including a seven-year period of marketing exclusivity, reduced regulatory fees, certain tax credits, and additional regulatory support for research and development initiatives.
"Receiving Orphan Drug Designation by the FDA is an important milestone for CureFAKtor, as well as for pancreatic cancer patients who have the lowest survival rate of any cancer and limited treatment options," said H. Shep Wild, President and Chief Executive Officer of CureFAKtor Pharmaceuticals. "CFAK-C4 is the first clinical candidate derived from our broad FAK technology platform and we look forward to progressing CFAK-C4 into human clinical trials."
CureFAKtor Pharmaceuticals is planning a Phase I clinical study of CFAK-C4 in combination with gemcitabine chemotherapy, the current standard of care for pancreatic cancer, in 2012.
CureFAKtor Pharmaceuticals was formed in 2008 based on fundamental discoveries of distinguished cancer researcher Dr. William Cance, Chair, Surgical Oncology, Surgeon-in-Chief Roswell Park Cancer Institute. The Company, to date, has been funded primarily by grants from the National Institutes of Health (NIH). CureFAKtor's proprietary FAK technology platform may represent a significant breakthrough in the treatment of most so
|SOURCE CureFAKtor Pharmaceuticals, LLC|
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