Vascular Biogenics Ltd (VBLT)

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VBL Therapeutics Provides Update on OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

https://finance.yahoo.com/news/vbl-therapeutics-provides-oval-phase-110000759.html

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 FDA as quickly as possible,” said Dror Harats, M.D., CEO of VBL Therapeutics. “Since receipt of the notification, we have submitted some of the requested information, and are preparing the remaining documentation, which we believe can be completed and submitted to the agency in the next two to three months. We do not expect a material change to our data readout timelines. We are in regular contact with the FDA and taking the steps necessary to minimize disruption to the trial in the U.S.”

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.

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.