Shares of Protara Therapeutics soared over 100% on Thursday, reaching $7.30 after the previous day's close at $3.54. The significant rise followed the announcement of positive results from the company's ongoing Phase 2 clinical trial for its investigational cell-based therapy, TARA-002, in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC).
Protara Therapeutics reported that TARA-002 showed a 72% complete response rate at the six-month landmark and a 70% complete response rate at any time across different patient exposures to Bacillus Calmette-Guérin (BCG), a common treatment for bladder cancer. Specifically, for patients unresponsive to BCG, the therapy achieved a 100% six-month landmark complete response rate, with 80% at any time. For BCG-Naïve patients, those who have not received BCG therapy, the six-month landmark complete response rate was 64%, with a 67% complete response rate at any time.
The trial also reported an 80% reinduction salvage rate, with all patients maintaining a complete response from three to six months. Notably, the treatment showed a favorable safety profile, with no severe treatment-related adverse events reported.
Dr. Brian Mazzarella, Vice President of Research for Urology America and an investigator in the ADVANCED-2 study, praised the results, stating, "These impressive TARA-002 results demonstrate meaningful activity in a difficult to treat patient population." He highlighted the potential of TARA-002 as a treatment option for NMIBC patients due to its efficacy and ease of use.
Jesse Shefferman, the CEO of Protara Therapeutics, expressed excitement over the six-month data, emphasizing the potential of TARA-002 in NMIBC treatment. He also mentioned that the positive data and expansion of international trial sites are expected to accelerate patient enrollment, with initial data from 12-month evaluable patients anticipated in mid-2025.
The majority of adverse events observed were mild and temporary, with the most common being flu-like symptoms and urinary tract-related issues, which typically resolved shortly after treatment. The company plans to host a conference call and webcast to discuss these findings further.
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