Protara Therapeutics Releases Early Cut Data From Investigational Cell-Based Therapy For Bladder Cancer

  • Protara Therapeutics Inc TARA announced preliminary results from the Phase 1a dose-escalation component of its ongoing ADVANCED-1 clinical trial of TARA-002 for high-grade non-muscle invasive bladder cancer (NMIBC). 
  • TARA-002 is the company's investigational cell-based therapy.
  • The clinical data indicate that TARA-002, a novel intravesical monotherapy, was generally well tolerated and showed anti-tumor activity.
  • TARA-002 was generally well tolerated at all three dose levels evaluated in the trial, and no dose-limiting toxicities were observed. 
  • A maximum tolerated dose was not determined, and dose escalation remains ongoing in exploratory cohorts. 
  • The company has selected the 40KE1 dose for use in subsequent clinical trials.  
  • Most reported adverse events were mild or moderate.
  • Patient enrollment is ongoing in the open-label expansion trial (ADVANCED-1EXP).
  • Protara plans to initiate ADVANCED-2 Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with carcinoma in situ (CIS). The study is expected to initiate in 2H of 2023.
  • In its Q4 earnings release, the company said a cash balance of $102.3 million as of December 31, 2022, will be sufficient to fund its planned operations and data milestones into 2025.
  • Price Action: TARA shares are up 2.48% at $3.31 on the last check Friday.
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