Future Development Plan

A joint FDA and American Urological Association (AUA) workshop conducted in May 2013 identified three Non-Muscle-Invasive Bladder Cancer (NMIBC) patient populations with a high unmet medical need:

  • Patients who are refractory to Bacillus Calmette–Guérin (BCG, the treatment of choice for this disease).
  • Patients who are intolerant to BCG.
  • Patients who have failed BCG therapy.

In line with this, BioCancell plans to initiate two Phase III studies toward the end of 2015, assessing the safety and efficacy of BC-819 for the treatment of NMIBC patients:

  • BCG Refractory & Intolerant Patients: A single-arm Phase III study.
  • BCG Failure Patients: A two-arm, controlled, combination Phase III study showing superiority over BCG alone. This study has received a Special Protocol Assessment (SPA) from the FDA.
BCG Refractory & Intolerant BCG Failure
Study Design Open, Single Arm Open, Two Arms
No. of Patients 120 235 patients/arm
Primary Endpoint Lack of recurrence at 18 months Time to recurrence
Study Duration 18 months  24 months
Dosing BC-819/PEI alone BC-819/PEI & BCG vs. BCG