VBL to present updated VB-111 Phase 1 trial results in advanced metastatic cancer at ASCO 2011

VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced that it will present updated results for a Phase 1 study of VB-111 in patients with advanced metastatic cancer at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place June 3-7, 2011, at McCormick Place in Chicago. Data from the trial evaluating the effect of VB-111 on 33 patients with advanced stage solid tumors demonstrate that VB-111 was well-tolerated and showed promising evidence of anti-tumor efficacy. The abstract for the poster (#3038) titled "A phase I trial of VB-111, a tissue- and condition-specific dual action vascular disruptive and antiangiogenic agent, for treatment of patients with advanced metastatic cancer," is now available on the ASCO Annual Meeting website and will be presented on June 6, 2011 from 8 a.m. to noon CT.

VB-111 is the first targeted, dual-action, anti-angiogenic and Vascular Disruptive Agent (VDA) to use VTS^™, the company's proprietary platform technology, for cancer therapy. VB-111 is an IV-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. VB-111 is currently being investigated in Phase 2 clinical studies in thyroid cancer and in glioblastoma.

The Phase 1 clinical trial, conducted at The Cleveland Clinic and The University of Texas Health Science Center at San Antonio, evaluated the safety, PK, immune and tumor responses of a single, intravenous administration of VB-111. Primary and secondary endpoints were safety and efficacy at 56 days after dosing. The trial enrolled a total of 33 patients across seven dose cohorts, with progressing, advanced solid tumors, with no existing curative therapy, who had adequate organ function and performance status. Patients had frequent clinical and laboratory safety evaluations. Tumor response was evaluated on day 28 and day 56.

VB-111 was found to be safe and well tolerated in these patients. Most patients in dosing cohorts 5 to 7 developed self-limited fever and chills. Both stable disease (SD) and partial response (PR) were observed in the trial. On day 56 evaluation, three of the 14 patients (21 percent) in cohorts 1 to 5 and nine of the 18 patients (50 percent) in cohorts 6 and 7 had SD. One patient (with papillary thyroid carcinoma) had a PR persisting for 18 months post dosing and three patients (one with neuroendocrine and two with thyroid carcinoma) had a significant decline in tumor-markers.

"We continue to be pleased and encouraged by the data demonstrated in preclinical and clinical studies of VB-111, including these findings which will be showcased at ASCO this year," said Yael Cohen, M.D., vice president of clinical development at VBL. "The results to date further demonstrate VB-111's promise as a targeted cancer treatment with potential efficacy across a broad range of cancers. We look forward to continuing to explore VB-111's unique mechanism of action, which allows it to target tumors with precision and specificity, and to advancing our ongoing Phase 2 clinical trials in thyroid cancer and glioblastoma."