Protara Therapeutics Announces Dosing of First Patients in Phase 1b ADVANCED-1EXP Trial of TARA-002 in NMIBC Patients with Carcinoma in Situ
- Dosing of first patients follows recent presentation of positive preliminary data from Phase 1a dose escalation portion of ADVANCED-1 trial
- Company advancing NMIBC clinical development program, with Phase 1b/2 trial in BCG-unresponsive CIS patients and in BCG-naïve and BCG-exposed CIS patients expected to initiate in 2H’2023
“Following positive preliminary results from the ADVANCED-1 trial, we are pleased to have dosed the first patients in our ADVANCED-1EXP trial,” said
ADVANCED-1EXP is a Phase 1b open-label expansion trial, which is evaluating intravesical TARA-002 at the 40KE1 dose in 12 CIS patients, including Bacillus Calmette-Guérin (BCG)-naïve, BCG-unresponsive and BCG-inadequately treated patients. Trial participants will receive six once-weekly intravesical instillations of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and signs of anti-tumor activity of TARA-002, and the planned primary endpoint is the complete response (CR) rate at three months.
In April 2023 at the American Urological Association Annual Meeting, the Company announced positive preliminary results from the Phase 1a dose-escalation component of the ADVANCED-1 clinical trial of TARA-002 for the treatment of patients with high-grade NMIBC. The clinical data indicate that TARA-002 was generally well tolerated and anti-tumor activity was observed, including tumor regression in all three evaluable patients with CIS, including one heavily pre-treated BCG-unresponsive patient who achieved a CR.
Based on these results, Protara plans to initiate ADVANCED-2, a Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with CIS. The Phase 1b trial is expected to enroll 27 patients with CIS (± Ta/T1), BCG-Naïve or BCG-exposed who have not received intravesical BCG for at least 24 months prior to CIS diagnosis. The Phase 2 trial is expected to enroll 75 patients with BCG-unresponsive CIS (± Ta/T1). ADVANCED-2 is expected to initiate in the second half of 2023.
TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs for which it has been granted Rare Pediatric Disease Designation by the
When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha are secreted by immune cells to induce a strong inflammatory reaction and destroy the abnormal cells.
About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.
About Protara Therapeutics, Inc.
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.
1. Klinische Einheit, or KE, is a German term indicating a specified weight of dried cells in a vial.
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Source: Protara Therapeutics