Clinical Trials

Date: 2017-12-27

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: VBL Therapeutics (Israel)

Product: VB-111 (ofranergene obadenovec)

Action mechanism:

gene therapy. VB-111 is a dual-action, anti-angiogenic and Vascular Disruptive Agent (VDA) that utilizes VTS™, VBL’s proprietary platform technology for cancer therapy. VB-111 is an intravenously administered VDA that works in a manner akin to a “biological knife” to destroy tumor vasculature, thus cutting off the blood vessels feeding the tumor. Preclinical pharmacological and toxicology studies of VB-111 showed tissue specificity for the tumor tissue, no significant damage to normal non-cancerous tissues or to the normal vasculatures in the body, and a more than 90 percent reduction in metastatic lung cancer model with one injection, as well as similar efficacy in other tumor models. A Phase 1 “all-comers” study of VB-111 in 33 patients with advanced metastatic cancer demonstrated antitumor activity and no effects on liver function or major changes in complete blood count.
VB-111 is also being studied in the GLOBE Phase 3 pivotal trial for recurrent glioblastoma (rGBM), conducted under an FDA Special Protocol Assessment (SPA), with top-line data expected in the first quarter of 2018. Ofranergene obadenovec has received Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU.

Disease: platinum-resistant ovarian cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The randomized, controlled, Phase 3 OVAL study in recurrent platinum-resistant ovarian cancer has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the United States and Israel. Patients will be randomized 1:1 to VB-111 in combination with chemotherapy, or chemotherapy alone. The primary endpoint is overall survival. Additional endpoints include objective response rate (ORR), progression free survival (PFS), combined CA-125 and RECIST 1.1 response (GCIG criteria) and patient reported outcome measures.

Latest news:

• On December 27, 2017, VBL Therapeutics announced the study initiation and first patient in its Phase 3 pivotal registration trial, OVAL, studying VB-111 (ofranergene obadenovec) in platinum-resistant ovarian cancer. The OVAL study will be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, a leading organization for research excellence in the field of gynecologic malignancies.
Richard Penson, MD, MRCP, associate professor of Medicine, Harvard Medical School, clinical director of Medical Gynecologic Oncology, Massachusetts General Hospital, is the Primary Investigator for the VB-111 Phase 2 trial and the Principal Investigator of the new OVAL study.
In December 2016, VBL held an End-of-Phase 2 meeting with the FDA to discuss the clinical path forward for VB-111 in ovarian cancer. The company has reached an agreement with the agency on the VB-111 Phase 3 pivotal study in platinum-resistant patients, with overall survival as the primary endpoint.