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VBL Therapeutics, NanoCarrier to Expand Clinical Trial of Ovarian Cancer Drug to Japan

NEW YORK – Tel Aviv-based biopharmaceutical company VBL Therapeutics today announced plans to extend its ongoing Phase III OVAL trial to Japan through a licensing agreement with NanoCarrier. The global, randomized OVAL trial is evaluating VBL's drug, VB-111, in patients with platinum-resistant ovarian cancer.

VB-111, or ofranergene obadenovec, is a targeted agent intended to treat a number of solid tumors – in this case, platinum-resistant ovarian cancer. The OVAL trial is specifically comparing a combination of VB-111 and the chemotherapy paclitaxel with placebo plus paclitaxel.

Although overall survival remains the primary endpoint for the OVAL trial, the plan to expand the trial to Japan come in the wake of a positive interim analysis that measured CA-125 as a surrogate endpoint. Using CA-125 as an endpoint remains controversial in ovarian cancer, in part because the biomarker is imprecise.

But in the case of the OVAL study, the choice of CA-125 as a surrogate endpoint piggybacks on the results from OVAL's Phase II trial, in which overall survival benefit corresponded with CA-125 response. Specifically, in the Phase II trial, patients with a CA-125 response demonstrated a median overall survival of 808 days, whereas patients without a CA-125 response demonstrated a median overall survival of 351 days. Fifty-eight percent of the patients treated with the VB-111 and paclitaxel combination demonstrated a CA-125 response.

The interim analysis of the Phase III trial showed that the first 60 participants treated with the VB-111-paclitaxel combination met the minimum advantage of a 10 percent CA-125 response rate. A Data Safety Monitoring Committee confirmed the advantage.

Under its licensing agreement with VBL, NanoCarrier intends to begin opening clinical sites in Japan. Should the Phase III OVAL trial yield positive outcomes, NanoCarrier would register VB-111 in Japan — a country in which more than 10,000 women are diagnosed with ovarian cancer and more than 5,000 die of the disease each year. Outside of Japan, VBL retains the rights to VB-111 globally.

"We are very pleased that NanoCarrier has chosen to develop VB-111 in ovarian cancer in Japan," VBL Therapeutics CEO Dror Harats said in a statement. "The extension of the OVAL study into Japan will open up another avenue of patient recruitment and may accelerate commercialization of VB-111 in this important market."