VBL Therapeutics Provides Update on OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer
Vascular Biogenics Ltd. - Ordinary Shares (VBLT)
Last vascular biogenics ltd. - ordinary shares earnings: 11/14 07:00 am
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Source: GlobeNewswire
TEL AVIV, Israel, June 15, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) 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. “Our team is working to provide the requested information to the
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