Under the FDA’s Accelerated Approval program, Bioniche Life Sciences, Inc., has completed phase 3 recruitment registration for its agent Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory to BCG.
Bioniche announced that it has 105 evaluable patients with BCG-refractory bladder cancer who received Urocidin in an open-label trial across 31 urology centers in North America. Urocidin, or Mycobacterial Cell Wall-DNA Complex (MCC), is derived from Mycobacterium phlei, a nonpathogenic strain.
The drug has demonstrated immunostimulatory properties and apoptotic activity against cancer cells. Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG as first-line treatment.