On September 17, 2021 VBL Therapeutics (NASDAQ: VBLT) reported that the independent Data Safety Monitoring Committee (DSMC) of the ongoing OVAL Phase 3 registration-enabling 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 (Press release, VBL Therapeutics, SEP 17, 2021, View Source [SID1234587867]).
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The independent DSMC for the OVAL trial is tasked with setting standards of safety, monitoring these standards’ implementation for the trial participants and treatment efficacy data, and acting on behalf of patients whenever necessary as the committee continues to monitor progress.
"We continue to be very pleased to learn that data collected to date in the OVAL clinical trial has passed independent DSMC review as we progress toward our enrollment goal," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "We thank the DSMC for its ongoing diligence, guidance and support."
The OVAL trial is planned to enroll approximately 400 adult patients globally and more than 320 patients (>80 percent) 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 the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration (FDA), compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.
About VB-111 (ofranergene obadenovec; `ofra-vec`)
VB-111 is an investigational anti-cancer, gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received orphan designation for the treatment of ovarian cancer by the European Commission. VB-111 has also received orphan drug designation in both the United States and Europe, and fast track designation in the United States, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and platinum-resistant ovarian cancer (NCT01711970).
About the OVAL Trial (NCT03398655)
OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. 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.