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VBL Therapeutics provides update on OVAL, a phase III registration enabling study of VB 111 in ovarian cancer.

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Published:16th Jun 2021
VBL Therapeutics provided an update on its ongoing OVAL Phase III study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer. The Company was notified by the 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.

Condition: Ovarian Cancer
Type: drug

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