VBL Announces Removal Of FDA Partial Clinical Hold On VB-111 - Quick Facts

(RTTNews) - VBL Therapeutics (VBLT) announced the U.S. FDA has determined that the company may proceed with its pivotal Phase 3 trial in patients with recurrent glioblastoma (rGBM) and removed the clinical hold on the trial, allowing the trial to proceed under a previously agreed upon special protocol assessment. In July 2014, the Phase 3 study of VB-111 in rGBM was placed on clinical hold, pending the submission of additional properties regarding the VB-111 potency assay developed by VBL. The company anticipates initiating Phase 3 pivotal trial of VB-111 in mid-2015.

VBL also announced that its Phase 2 studies evaluating lead Lecinoxoid compound VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints. The company does not plan to continue development of VB-201 in these indications.