On March 3, 2014 Heat Biologics reported that the first patient has been dosed in its Phase 1/2 bladder cancer clinical study with product candidate, HS-410 (Press release Heat Biologics, MAR 3, 2014, View Source [SID:1234500207]). HS-410 is an investigational biologic designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer. Dosing for the HS-410 Phase 1/2 study was initiated by clinical investigator Lawrence Karsh, M.D., F.A.C.S., at The Urology Center of Colorado in Denver.
The multi-center Phase 1/2 study will enroll approximately 93 patients and is designed to determine whether vaccination with HS-410 after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG) extends the time to disease recurrence compared to placebo. The trial will also test the safety of HS-410 in bladder cancer patients.