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FDA grants fast track designation to TPIV 200 for ovarian cancer
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The FDA today granted fast track designation to TPIV 200 for the treatment of ovarian cancer, according to a press release.
TPIV 200 (TapImmune Inc.) — a multiple epitope Folate Receptor Alpha Peptide vaccine — is currently under investigation with adjuvant granulocyte-macrophage colony–stimulating factor. The combination is intended for use as maintenance therapy for patients with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following their completion of standard of care chemotherapy.
“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 2 trials in the near future to address this highly aggressive cancer,” Glynn Wilson, MD, chairman and CEO of TapImmune, said in the release. “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.”
This designation follows recent orphan drug designation for TPIV 200 for the same designation.