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VBL Therapeutics Expands Ongoing OVAL Phase 3 Study On Ofranergene Obadenovec Into Europe

VBL Therapeutics (VBLT) announced Tuesday the expansion of its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer into Europe, where the first patient has now been enrolled.

The study continues to actively recruit patients in the U.S. and Israel, with over 200 patients enrolled to date.

VB-111 is VBL's proprietary anti-cancer gene therapy product candidate that has shown overall survival benefit across multiple tumor types. Interim analysis from OVAL demonstrated VB-111's significant response rate of 58% or higher in the first 60 patients.

The EU expansion follows two completed analyses by the independent Data Safety Monitoring Committee (DSMC) which recommended to continue the study as planned. The next DSMC review is expected in the first quarter of 2021.

VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.

OVAL is an international Phase 3 randomized pivotal potential registration 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.

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