Protara Therapeutics Doses First Patient in Bladder Cancer Clinical Trial
Protara Therapeutics, Inc. (Nasdaq: TARA) has dosed the first patient in its Phase 1b ADVANCED-1EXP open label clinical trial evaluating TARA-002 for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ. NMIBC is highly recurrent and has limited treatment options.
The company’s share price rose to $2.47 following the news.
Highlights
Trial participants will receive six once-weekly intravesical instillations of TARA-002.
The trial will evaluate the safety, tolerability and signs of anti-tumor activity of TARA-002, and the planned primary endpoint is the complete response rate at three months.
Protara reported positive preliminary results from its Phase 1a dose-escalation clinical trial which indicated that TARA-002 was generally well tolerated and anti-tumor activity was observed, including tumor regression in all three evaluable patients with carcinoma in situ.
TARA-002 has been granted Rare Pediatric Disease Designation by the FDA.Bladder cancer is the 6th most common cancer in the United States. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year.
About Protara Therapeutics
Protara is committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead program, TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer and lymphatic malformations, and IV Choline Chloride, an investigational phospholipid substrate replacement for patients dependent on parenteral nutrition. For more information, visit www.protaratx.com.
