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CureFAKtor Pharmaceuticals. LLC Receives Orphan Drug Designation for Its Lead Compound CFAK-C4 for the Treatment of Pancreatic Cancer



1/18/2011 10:28:36 AM

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 solid tumors in that its unique mechanism of action disrupts the signaling of FAK in tumors by targeting specific protein to protein bindings. Since FAK is over-expressed in virtually all solid tumors, the technology has broad applicability in oncology.

More than 40 compounds have been identified that target FAK signaling sites. CFAK-C4, discovered by Dr. Elena Kurenova, Ph.D. Associate Professor, Roswell Park Cancer Institute, Senior Scientist and Co-Founder of CureFAKtor, is the lead product candidate in CureFAKtor's pipeline. In pre-clinical studies, CFAK-C4 demonstrated efficacy in a number of cancers including pancreatic, breast, advanced melanoma and neuroblastoma. The Company's second product candidate, CFAK-Y15, discovered by Dr. Vita Golubovskaya, Ph.D. Associate Professor, Roswell Park Cancer Institute, Senior Scientist and Co-Founder of CureFAKtor, is being investigated for the treatment of breast, pancreatic, neuroblastoma and colon cancer.

CureFAKtor has attracted a renowned Board of Directors which includes David Keiser, Former President and Co-Founder of Alexion Pharmaceuticals, Inc. and Dr. Daniel Kleiner, Surgeon and Clinical Instructor at the University of Virginia. Scientific Advisory Board members include: Dr. Murray Brennan, Former Chair of Surgery at Memorial Sloan-Kettering Cancer Center; Dr. Edison Tak-Bun Liu, Executive Director of Human Genome Institute of Singapore; and Dr. Alex Adjei, Senior Vice President of Clinical Research and Chair of the Department of Medicine at Roswell Park Cancer Institute.

"Focal Adhesion Kinase protein binding inhibitors represent a promising area of research as FAK is expressed at extremely high levels in solid cancer tumors to serve as a survival mechanism by signaling tumor growth, invasion and metastasis. Dr. William Cance's groundbreaking work has shown that FAK protects tumors from chemotherapy, radiation and the body's natural defenses," said Dr. H. Shelton Earp III, M.D., Professor and Director of Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill School of Medicine. "While still early stage, I look forward to further research into the effect CFAK-C4 may have on solid tumors."

About Focal Adhesion Kinase (FAK)

Focal adhesion Kinase (FAK) is substantially over-expressed in many solid tumors. FAK operates by placing itself at the contact points between tumor cells and the extra cellular matrix that surrounds them. Studies by CureFAKtor and others found that in this role, FAK is an important facilitator for signals that cause tumor cells to survive, grow, and produce new blood vessels to sustain growth and travel to distant places within the body where they may establish new tumor sites. It also cocoons the tumor cells to protect them from the body's natural signaling mechanisms that would cause deviant tumor cells to be eliminated. In a similar fashion, FAK protects tumors from chemotherapeutic drugs and radiation, allowing the tumor cells to resist these therapies.

About CureFAKtor Pharmaceuticals

CureFAKtor Pharmaceuticals is a biopharmaceutical company focused on the research and development of Focal Adhesion Kinase therapies to prevent or treat cancer. CureFAKtor's investigational and combination therapy products target pancreatic, breast, colon, melanoma, lung and brain oncology disorders. CureFAKtor research is conducted at the Roswell Park Cancer Institute. Additional information about the company may be found at www.curefaktor.com

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements for CureFAKtor Pharmaceuticals that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements.

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SOURCE CureFAKtor Pharmaceuticals, LLC


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