On March 9, 2015 Heat Biologics reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer (NMIBC) (Filing, 8-K, Heat Biologics, MAR 10, 2015, View Source [SID:1234502283]). HS-410 is Heat’s NMIBC product candidate and is based on its breakthrough Immune Pan Antigen Cytotoxic Therapy ("ImPACT") platform that is designed to generate killer T cells to attack cancers. HS-410 is currently being evaluated in a randomized Phase 2 trial in combination with BCG and as monotherapy for the treatment of NMIBC.
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"We are very pleased that FDA has granted this important designation for HS-410," said Melissa Price, Ph.D., Heat’s Vice President of Clinical Development and Regulatory Affairs. "The decision underscores the unmet need for bladder cancer treatments and serves as an additional validation for our clinical program. Currently there are limited therapeutic treatment options available for this patient population, with no new treatments approved in this setting in over 30 years."