FDA grants Fast Track Designation to TapImmune’s TPIV 200
Posted: 3 February 2016 | | No comments yet
The FDA has granted the designation for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer…
The US Food & Drug Administration (FDA) has granted Fast Track Designation for TapImmune’s cancer vaccine TPIV 200 in the treatment of ovarian cancer.
The FDA has designated the investigation of multiple-epitope Folate Receptor Alpha Peptide Vaccine (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 Programme.
Under the FDA Modernisation Act of 1997, 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.
“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 programme. We look forward to starting Phase II trials in the near future to address this highly aggressive cancer”, commented Dr Glynn Wilson Chairman & CEO of TapImmune. “We believe that TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis”.
Approximately 21,290 women were diagnosed with ovarian cancer in 2015 in the US and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the five-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy. There is currently no FDA approved cancer vaccine available for ovarian cancer.