On Thursday, Protara Therapeutics Inc. TARA stock traded higher after the company revealed results from its ongoing Phase 2 open-label ADVANCED-2 trial.
The trial is assessing intravesical TARA-002, the company’s investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
Also Read: Protara Therapeutics Shares Interim Data From Bladder Cancer Study, Raises $45M Via Equity
The complete response (CR) rate across BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time, with 100% (9/9) of patients maintaining a CR from three to six months.
In addition, two of three patients maintained a CR at nine months.
The results will be featured at the 25th Annual Meeting of the Society of Urologic Oncology.
The dataset includes 20 patients who were evaluable at three months, 18 at six months, and three at nine months, with a data cutoff of November 19.
In the pivotal cohort of the ADVANCED-2 trial in BCG-Unresponsive patients, the CR rate was 100% (4/4) at six months and 80% (4/5) at any time.
In the proof-of-concept cohort of BCG-Naïve patients, the CR rate was 64% (9/14) at six months and 67% (10/15) at any time.
TARA-002 demonstrated a favorable safety and tolerability profile with no Grade 2 or greater treatment-related adverse events (TRAEs) and no patients discontinued due to adverse events.
The company looks forward to reporting initial data from 12-month evaluable patients in mid-2025.
Price Action: At last check Thursday, TARA stock was up 119% at $7.73.
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