TapImmune Granted Fast Track Designation by FDA for Lead Vaccine TPIV 200 in the Treatment of Ovarian Cancer

- February 3rd, 2016

TapImmune, Inc. (OTCMKT:TPIV) announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.

TapImmune, Inc. (OTCMKT:TPIV) announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.
According to the company press release:

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 Program.
Under the FDA Modernization 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.

Dr. Glynn Wilson Chairman & CEO of TapImmune stated:

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. 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.

Click here to view the full press release. 

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