Vascular Biogenics Ltd. (VBLT) stock declined 0.84% in the current-market trading session at the price of $2.37 following the clearance granted by DSMC to further continue the clinical research of its ongoing OVAL Phase 3 study of VB-111. VBLT is a clinical-stage biopharmaceutical company. It discovers, produces, and commercializes first-in-class therapies to treat cancer and inflammatory indications.
DSMC Granted Clearance to Proceed OVAL Phase 3 Study of VB-111
On 17th September 2021, VBLT published that DSMC has conducted its fifth pre-planned review of the OVAL Phase 3 study of VB-111 in patients with ovarian cancer. The independent Data Safety Monitoring Committee has also granted clearance to continue clinical research with no protocol changes. The DSMC had tasked with setting safety standards, monitoring standards’ implementation, and treatment efficacy data, and acting on behalf of patients where necessary. The OVAL trial has already been recruited more than 320 patients and is planning to enroll 400 more adult patients globally. The two primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS). Successfully meeting the primary endpoint will support the biologics license application (BLA).
CEO of VBLT, Prof. Dror Harats, remarked that they are happy to learn that data collected in the OVAL clinical trial had passed independent DSMC review. He thanked the DSMC for its continuous guidance and support in their clinical trial of VB-111 in ovarian cancer.
VBLT to Present at Upcoming Conferences
On 10th September 2021, VBLT announced that it would present at the upcoming industrial conference on 22nd September 2021. Oppenheimer Fall Healthcare Life Sciences & MedTech Summit will take place on Wednesday, from 1:15 PM to 1:55 PM (ET). Webcasts will be available on Company’s Investor Relations page at the “Events and Presentations” section.
VBLT Resumed U.S. Enrollment in OVAL Phase 3 Trial
On 30th August 2021, VBLT announced that it had resumed enrollment of new patients in VB-111 studies following authorization granted by the Food and Drug Administration. The VB-111 had produced in VBL’s commercial-scale GMP Modiin at Israel facility. The Chemistry, Manufacturing, and Controls Group of FDA permitted the company to use new batches of ofranergene obadenovec in clinical studies in the United States. Earlier in June, VBLT had been notified by FDA about the pending technical review of clearance of its new VB-111 batches for clinical use in the U.S. In early August, the company submitted the requested data and documentation to the CMC group of FDA to continue the review process.