Benzinga | Dec 15, 2020 09:01AM EST

Rafael Pharmaceuticals Receives FDA Fast Track Designation For CPI-613 For the Treatment Of Acute Myeloid Leukemia

CRANBURY, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) -- 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(r) (devimistat), for the treatment of acute myeloid leukemia (AML).



"Receiving Fast Track designation, especially during a pandemic that has created significant challenges for many trials across the globe, is a testament to the dedicated work of the Rafael team," said Sanjeev Luther, President and CEO of Rafael. "We would not be here without the support of the FDA, our doctors, our patients, and all who are invested in the hope of finding a successful treatment for this hard-to-treat cancer."

While one of the most common types of leukemia in adults, AML accounts for only 1% of all cancers.

"This designation underscores the pressing need to find new ways to combat this aggressive disease," said Jorge Cortes, M.D., Director of the Georgia Cancer Center at Augusta University and principal investigator on the Phase 3 clinical trial. "It brings hope not only to clinicians, but to patients who hear that they have been diagnosed."

"We would not be here today without our principal investigator Jorge Cortes, M.D., the FDA, and leadership at Rafael who remain focused on patient care," said Timothy S. Pardee, M.D., Ph.D., Co-Chief Medical Officer of the Company. "We are a community coming together to fight a common enemy, and I believe we are gaining ground in this battle every day."

This announcement comes on the heels of the Company receiving Fast Track designation for devimistat for the treatment of metastatic pancreatic cancer, in November. The company has continued to reach milestones throughout the year, including the recent Orphan Drug Designation for the treatment of soft tissue sarcoma for devimistat, and the initiation of a Phase 2 clinical trial of devimistat in combination with hydroxychloroquine in patients with clear cell sarcoma of soft tissue.