(RTTNews) - Protara Therapeutics Inc. (TARA) is scheduled to present new interim data from Cohort A of its ongoing Phase 2 trial assessing investigational cell-based therapy, TARA-002, in patients with Non-Muscle Invasive Bladder Cancer at the upcoming 26th Annual Meeting of the Society of Urologic Oncology on December 4, 2025.
In the phase 2 trial, dubbed ADVANCED-2, the safety and anti-tumor activity of intravesical TARA-002 is being evaluated in adults 18 years of age or older with high-risk non-muscle invasive bladder cancer (NMIBC), specifically those with carcinoma in situ (CIS) who are BCG-unresponsive or BCG-naïve.
The study includes two cohorts, A and B.
Cohort A:
Participants with CIS who are BCG naive, or Participants with CIS who are BCG exposed and have not received intravesical BCG for at least 24 months before the most recent CIS diagnosis
Cohort B:
Participants with persistent or recurrent CIS who are BCG unresponsive within 12 months of completion of adequate BCG therapy.
Bladder cancer is the sixth most common cancer in the U.S., with NMIBC representing about 80% of the diagnoses. Approximately 65,000 patients are diagnosed with NMIBC annually in the U.S.
The presentation will include updated safety and efficacy data form 31 enrolled BCG-naïve patients, most of whom have reached the six-month evaluation point.
Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.
According to the ADVANCED-2 trial results, reported in April of this year, TARA-002 achieved a 100% complete response rate at any time and a 67% complete response rate at 12 months in BCG-Unresponsive patients. Among BCG-naïve patients, TARA-002 demonstrated a 76% complete response rate at any time and a 43% complete response rate at 12 months.
Final data readouts and regulatory interactions with the FDA are anticipated in 2026.
TARA has traded in the range of $2.21 to $10.48 over the past year. The stock closed yesterday's trading at $5.57, up 1.09%.
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