Protara : FDA Clears IND Application for TARA-002 in Bladder Cancer

 Protara Therapeutics Inc. said the U.S. Food and Drug Administration cleared its investigational new drug application for TARA-002 for the treatment of non-muscle invasive bladder cancer, sending shares higher in premarket trade.

Protara, a clinical-stage company focused on cancer and rare diseases, said it expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of this year.

The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a maximum tolerated dose and recommended dose for a future Phase 2 clinical study.

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