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Protara Therapeutics Announces Positive Preliminary Data from ADVANCED-1 Phase 1a Dose Escalation Trial of TARA-002 in NMIBC Supporting Advancement into Phase 2 Clinical Development
Favorable tolerability observed in patients with NMIBC treated with TARA-002 in ADVANCED-1 trialAnti-tumor activity was observed in all three evaluable
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"Favorable tolerability observed in patients with NMIBC treated with TARA-002 in ADVANCED-1 trialAnti-tumor activity was observed in all three evaluable patients with CIS, including one heavily pre-treated BCG-unresponsive patient who achieved a complete responseCompany’s current resources are expected to fund operations into 2025 supporting the initiation of the ADVANCED-2 trial in BCG-naïve CIS patients and BCG-unresponsive CIS patients in 2H’2023 NEW YORK, April 28, 2023 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced positive preliminary results from the Phase 1a dose-escalation component of its ongoing ADVANCED-1 clinical trial of TARA-002, the Company’s investigational cell-based therapy, for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC). The clinical data indicate that TARA-002, a novel intravesical monotherapy, was generally well tolerated and showed anti-tumor activity in high-grade NMIBC patients. The data will be featured during a moderated poster session at the American Urological Association (AUA) 2023 Annual Meeting being held in Chicago from April 28, 2023 to May 1, 2023. “These promising results suggest TARA-002 may provide meaningful benefit to patients with NMIBC, who currently have limited treatment options,” said Neal Shore, M.D., Medical Director, Carolina Urologic Research Center, Chief Medical Officer, GenesisCare US, and study investigator. “These data show favorable tolerability and initial evidence of anti-tumor activity, thus serving as an impetus to advance TARA-002 into larger, later-stage trials.” “We are highly encouraged by preliminary results from the dose-escalation component of ADVANCED-1 and look forward to deepening our understanding of TARA-002’s potential in the ongoing expansion trial, which is currently enrolling NMIBC patients with carcinoma in situ (CIS),” said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. “We plan to initiate larger clinical trials in NMIBC patients with CIS who are Bacillus Calmette-Guérin (BCG)-naïve and BCG-unresponsive in the second half of this year.” Preliminary Results TARA-002 was generally well tolerated at all three dose levels evaluated in the trial, and no dose...