VBL Therapeutics: First Patient Dosed In VB-111 Phase 3 Trial - Quick Facts

(RTTNews) - VBL Therapeutics (VBLT) announced that the first patient has been dosed in the company's GLOBE Study, a Phase 3 trial of VB-111, an intravenously-administered, gene-therapy biological agent for the specific inhibition of tumor vascular growth, in recurrent glioblastoma.

The GLOBE trial is designed to evaluate the efficacy, safety and tolerability of VB-111. The primary endpoint of the study is overall survival. The trial is proceeding under a special protocol assessment granted by the FDA. Interim data from the Phase 3 trial is expected in the second half of 2016.

"This is an unusual situation in which the FDA encouraged VBL to launch this single needed pivotal Phase 3 trial for registration even prior to the completion of an ongoing Phase 2 trial," said Dror Harats, CEO of VBL.