Vascular Biogenics Ltd (NASDAQ:VBLT) is moving higher in the pre-market session on Monday after slipping earlier. The stock has gained 32% over the past month.
Major Trigger:
Vascular Biogenics : VBL Therapeutics Provides Update on OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer (Form 6-K)
Key Highlights:
- today provided an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer.
- The Company was notified by the U.S Food and Drug Administration (FDA) that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review by the Chemistry, Manufacturing, and Controls (CMC) group, which is evaluating the comparability of VB-111 manufacturing between different source sites.
- Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S. Accordingly, recruitment of new patients in the U.S. will be temporarily paused. Treatment will continue as usual for all U.S. patients currently enrolled. To-date, the study has enrolled approximately 75% of the planned 400-patients.
- VBL recently amended the primary endpoint of OVAL based upon requested changes by the Company that were reviewed by the FDA. OVAL now includes a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.
Market Reaction
As of 8:41, VBLT stock jumped 3% to $2.75. So far the stock has traded 142K shares traded hands.
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