TapImmune Inc. (TPIV), a clinical-stage immuno-oncology company, said that the U.S. Food & Drug Administration or FDA has granted Fast Track Designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.
The FDA has designated the investigation of multiple-epitope Folate Receptor Alpha Peptide Vaccine or TPIV 200 with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy, as a Fast Track Development Program.
Designation as a Fast Track product for a new drug or biological product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. The fast track designation follows recent Orphan Drug Designation for TPIV 200 in the same indication.
"We believe that the FDA's decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We look forward to starting Phase II trials in the near future to address this highly aggressive cancer", said Dr. Glynn Wilson, Chairman & CEO of TapImmune.
Approximately 21,290 women were diagnosed with ovarian cancer in 2015 and an estimated 14,180 will die from the disease according to the American Cancer Society. There is currently no FDA approved cancer vaccine available for ovarian cancer.
For comments and feedback: editorial@rttnews.com