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Protara Therapeutics Announces Dosing of First Patient in Phase 1b/2 ADVANCED-2 Trial of TARA-002 in NMIBC Patients with High Grade Carcinoma in Situ
Dosing is progressing on schedule in ongoing ADVANCED-1EXP trial evaluating TARA-002 in NMIBC patients with CIS; preliminary results expected in 1H24 NEW
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"Dosing is progressing on schedule in ongoing ADVANCED-1EXP trial evaluating TARA-002 in NMIBC patients with CIS; preliminary results expected in 1H24\nNEW YORK, Sept. 20, 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 that dosing is now underway in its Phase 1b/2 ADVANCED-2 trial evaluating intravesical instillation of TARA-002, the Company’s investigational cell-based therapy, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) patients with Bacillus Calmette-Guérin (BCG)-naïve and BCG-unresponsive carcinoma in situ (CIS). In addition, dosing is progressing in the ongoing ADVANCED-EXP trial started earlier this year with preliminary results expected in the first half of 2024. “The ADVANCED-2 trial in NMIBC is an exciting opportunity to build on the favorable anti-tumor and safety data of TARA-002 presented earlier this year,” said Tom Jayram, M.D., Director, Advanced Therapeutics Center, Urology Associates, P.C., TN and study investigator for the ADVANCED-2 trial. “There is significant need for new intravesical approaches for NMIBC, which can recur and progress to invasive disease with current treatments. This trial looks at the potential clinical benefit of TARA-002 as a possible new therapy for NMIBC, across both BCG-naïve and BCG-unresponsive patient populations.” The initiation of this trial follows the positive results of the ADVANCED-1 clinical trial of TARA-002 presented in April 2023 at the American Urological Association Annual Meeting. In the dose-escalation component of that study, TARA-002 was generally well tolerated and anti-tumor activity was observed, including tumor regression in all three evaluable patients with CIS, including one heavily pre-treated BCG-unresponsive patient who achieved a complete response (CR). “Following positive preliminary results from the ADVANCED-1 trial, we are pleased to have dosed the first patient in the ADVANCED-2 trial,” said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. “We believe TARA-002 has the potential to play a meaningful role in the NMIBC treatment landscape and look forward to progressing the trial in parallel with our ongoing ADVANCED-1EXP study.” ADVANCED-2 (NCT05951179) is a Phase...