Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer

Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead compound, CPI-613® (devimistat), for the treatment of metastatic pancreatic cancer. 

“Receiving Fast Track designation is a significant milestone in our fight against pancreatic cancer,” said Sanjeev Luther, President and CEO of Rafael. “This designation further stresses the severe unmet need in treatment options for this aggressive and devastating disease. We are truly thankful to the doctors, researchers, the FDA and all of our supporters who have made this possible. And most of all, we are grateful to the patients involved in our trials; the patients are the inspiration and driving force behind all of our efforts.”  

Rafael has continued to reach milestones throughout the year, including achieving its target enrollment of 500 patients for its Phase 3 trial for metastatic pancreatic cancer ahead of schedule. The Company also recently announced that the FDA granted devimistat Orphan Drug Designation for the treatment of soft tissue sarcoma.  

“Pancreatic cancer is notoriously challenging to treat and long overdue for a new approach,” said Philip A. Philip, M.D., Ph.D., FRCP, Professor of Oncology at the Barbara Ann Karmanos Cancer Institute at Wayne State University and a medical advisor to Rafael. “We have remained hopeful throughout our pancreatic cancer trials, and now with Fast Track designation, our optimism is further fueled. We believe with this designation, cancer metabolism is truly being propelled forward, with devimistat at the helm.”

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