Vascular Biogenics Ltd (NASDAQ:VBLT) operating as VBL Therapeutics disclosed that an Independent Data Safety Monitoring Committee recommended it to continue its final stage GLOBE trial investigating VB-111 in recurrent glioblastoma (rGBM). The committee conducts a detailed review of un-blinded trial data, discusses possible safety concerns and offer recommendations on trial continuation. Following this, the stock jumped in extended hours trading on Thursday and could continue the trend on Friday too.
Vascular Biogenics revealed that the committee reviewed its data in March and advised to ahead as planned. The conclusion came after the committee conducted its safety review of the final stage GLOBE trial investigating ofranergene obadenovec (VB-111) in rGBM.
The company disclosed that the final stage trial in rGBM is comparing VB-111 in alliance with Avastin and recruited 256 patients in the Israel, Canada and the United States. The trial is going on under a special protocol assessment granted by the FDA that has full endorsement of the Canadian Brian Tumor Consortium.
Vascular Biogenics indicated that the company has got orphan drug status in Europe and the United States besides being granted fast track designation by the regulator in the United States for prolongation of survival in patients with glioblastoma. The disease happens after treatment with standard chemotherapy and radiation.
The company’s CEO, Dror Harats, commented, “We are pleased with the outcome of the DSMC. Based on enrollment trends and events that triggered the DSMC review, we currently expect the GLOBE Trial interim analysis to occur in mid-2017, and top-line results from the full dataset to be available in early 2018.”
Following the positive results, Vascular Biogenics shares surged 16.35 percent in after-hours trading on Thursday.