TARA - Protara Therapeutics' TARA-002 shows positive results in phase 1a trial for bladder cancer stock surges by 8%

2023-04-28 08:59:54 ET

• Protara Therapeutics ( NASDAQ: TARA ) has reported encouraging preliminary results from a Phase 1a dose-escalation trial of its investigational cell-based therapy, TARA-002, aimed at treating high-grade non-muscle invasive bladder cancer (NMIBC) patients.
• ( TARA ) is up 8.5% premarket.
• The clinical data indicates that TARA-002, a novel intravesical monotherapy, was generally well-tolerated by patients and demonstrated anti-tumor activity in those with high-grade NMIBC.
• During the trial, TARA-002 was well-tolerated across all three dose levels evaluated, and no dose-limiting toxicities were observed. Although the trial did not establish a maximum tolerated dose, dose escalation is still ongoing in exploratory cohorts.
• The company has selected the 40KE dose level based on the positive results observed in the Phase 1a trial, for subsequent clinical trials.
• The study enrolled a total of nine patients, of which three had carcinoma in situ ( CIS ) and reached the three-month efficacy assessment. Among the three CIS patients, one heavily pre-treated BCG-unresponsive patient achieved a complete response ( CR ) at the 20KE dose level, and tumor regression was observed in the other two patients with CIS.
• The company's resources are expected to fund operations until 2025, enabling the initiation of the ADVANCED-2 trial in the second half of 2023.
• The trial will focus on evaluating the efficacy of TARA-002 in treating patients with CIS who have not previously undergone BCG therapy (BCG-naïve CIS) or those who are unresponsive to it (BCG-unresponsive CIS).
• Press Release

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