- Vascular Biogenics (NASDAQ:VBLT), operating as VBL Therapeutics has paused the recruitment of new patients in the U.S. for its ongoing OVAL Phase 3 study designed to investigate ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer. Vascular Biogenics has lost ~9.7% in the pre-market.
- The OVAL study has enrolled nearly 75% of the planned 400-patients to date. The FDA has informed the company that the regulatory clearance of new VB-111 batches for use in the U.S. is pending the completion of a technical review.
- “Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S.” VBL Therapeutics said in the statement adding that the treatment will continue as usual for all currently enrolled U.S. patients.
- Early this month, VBL Therapeutics announced an amendment to the study adding a second, separate primary endpoint to measure the progression-free survival (PFS).