- The stock price of Vascular Biogenics Ltd (NASDAQ: VBLT) is trading at over 10% pre-market. These are the details.
The stock price of Vascular Biogenics Ltd (NASDAQ: VBLT) — operating as VBL Therapeutics — is trading at over 10% pre-market as of 8:59 AM ET. Investors are responding to VBL Therapeutics announcing the results of the independent Data Safety Monitoring Committee (DSMC) pre-planned review of the ongoing OVAL Phase 3 registration enabling study of VB-111 in recurrent ovarian cancer. And the committee found no safety issues with the trial and recommended its continuation as planned.
In March 2020, the company announced results of the first interim analysis in the OVAL study — which reviewed unblinded data and assessed CA-125 response, measured according to the GCIG criteria, in the first 60 enrolled subjects evaluable for CA-125 analysis. And the overall response rate across both arms was 53%.
The response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was at least 10% higher than in the control, i.e., 58% or higher. And in patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%. According to the company update on November 16, 2020, a high response rate of >50% in the total evaluable patient population was maintained with approximately 200 patients enrolled.
“This review continues the trend of encouraging reviews that have taken place since the clinical trial began. The trial continues to enroll on track in the US, Europe, and Israel. We look forward to the next DSMC review during the third quarter of 2021, followed by completion of enrollment at the end of 2021 or in early 2022.”
— Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics