Replies to post #2032 on Vascular Biogenics Ltd (VBLT)

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VBL Therapeutics on go with Phase 3 VB-111 study in ovarian cancer after DSMC recommendation

Sep. 17, 2021 7:23 AM ETVascular Biogenics Ltd. (VBLT)

By: Mamta Mayani, SA News Editor

VBL Therapeutics (NASDAQ:VBLT) announces that the independent Data Safety Monitoring Committee (DSMC) of the ongoing OVAL Phase 3 study of VB-111 in ovarian cancer has conducted its fifth pre-planned review and has provided clearance to proceed with further clinical research as planned with no changes to the protocol.

The OVAL trial is planned to enroll ~400 adult patients globally and more than 320 patients (>80%) have already been recruited.

The trial has two primary endpoints: progression free survival (PFS) and overall survival (OS).

Successfully meeting either primary endpoint has the potential to support a biologics license application (BLA).

Meeting the PFS endpoint, with a readout anticipated in H2 2022, could accelerate BLA submission by approx. one year, based on the readout of the OS primary endpoint that remains anticipated in 2023.