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Protara Therapeutics Announces FDA Clearance of Investigational New Drug Application for TARA-002 for the Treatment of Non-Muscle Invasive Bladder Cancer
- Company Plans to Initiate Phase 1 Study of TARA-002 by Year-End - - IND Application Included Submission of Confirmatory Large-Scale GMP Comparability Data -
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"- Company Plans to Initiate Phase 1 Study of TARA-002 by Year-End - - IND Application Included Submission of Confirmatory Large-Scale GMP Comparability Data - NEW YORK, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). Protara expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021. “We are thrilled to have reached this important milestone and look forward to quickly initiating our Phase 1 study in patients with NMIBC,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “There is an urgent need for new treatments for NMIBC. We are seeing significant increases in recurrence and disease progression, as well as an escalating number of patients requiring cystectomies. Supported by the strength of the existing clinical data in NMIBC for OK-432, the originator therapy for TARA-002, we believe this treatment represents a promising new option for NMIBC patients.” The Phase 1 dose-finding, open-label trial will evaluate TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. 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 trial. TARA-002 is manufactured from the same cell bank as OK-432, an approved therapy in Japan and Taiwan for multiple oncologic indications. In 2020, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432. The confirmatory, GMP-scale comparability data for TARA-002 in relation to OK-432 have been completed and were reviewed by FDA as part of the clearance of the IND. About TARA-002TARA-002 is an investigational cell therapy ...