Protara Therapeutics, Inc. ((TARA)) announced an update on their ongoing clinical study.
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Protara Therapeutics, Inc. is conducting a Phase 2 clinical study titled ‘A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer.’ The study aims to assess the safety and anti-tumor activity of TARA-002 in adults with high-grade non-muscle invasive bladder cancer (NMIBC), particularly focusing on patients with carcinoma in situ (CIS) with or without Ta/T1 tumors. This study is significant as it seeks to provide an alternative treatment for patients who are either BCG naive or have shown unresponsiveness to BCG therapy.
The intervention being tested is TARA-002, a biological preparation for intravesical instillation containing treated cells of Streptococcus pyogenes. It is designed to target and treat high-grade NMIBC by instilling the preparation directly into the bladder.
The study follows an interventional, open-label design with a single-group assignment. There is no masking involved, and the primary purpose is treatment. Participants will receive TARA-002 in multiple treatment periods, including initial, reinduction, and maintenance phases, followed by a long-term follow-up.
The study began on June 29, 2023, and is currently recruiting participants. The primary completion and estimated study completion dates have not been specified, but the latest update was submitted on October 23, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The update on this study could influence Protara Therapeutics’ stock performance as it progresses, potentially boosting investor confidence if the results are favorable. The study’s outcome may also impact the competitive landscape in the bladder cancer treatment market, particularly for companies focusing on non-muscle invasive bladder cancer therapies.
The study is ongoing, and further details are available on the ClinicalTrials portal.