Aravive Biologics, Inc. announced today that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer.
"Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet medical need for patients with recurrent ovarian cancer," said Ray Tabibiazar, M.D., Executive Chairman of Aravive Biologics. "We look forward to initiating the Phase 1b portion of our planned Phase 1b/2 study combining AVB-S6-500 with standard-of care therapies in patients with platinum-resistant ovarian cancer before the end of the year."
The FDA's Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
"We are very pleased that the FDA has granted Fast Track status to AVB-S6-500," said Gail McIntyre Ph.D., DABT, Senior Vice President of R&D at Aravive. "This important designation is based on the promising safety and activity observed to-date with AVB-S6-500, and we look forward to working closely with the FDA as we advance its development in ovarian cancer."