VBL Therapeutics announced that following the positive interim analysis in the OVAL study, NanoCarrier Co., Ltd., intends to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan. NanoCarrier will be responsible for all required operations and expenses related to the study in Japan. VBL and NanoCarrier Co.

Ltd. signed an exclusive license agreement in 2017 for the development, commercialization, and supply of VB-111 in Japan. There are more than 10,000 women diagnosed with ovarian cancer in Japan with more than 5,000 associated deaths annually. Therefore, opening clinical sites in Japan will enable to expedite the OVAL trial globally as well as the potential registration of the VB-111 in Japan upon positive outcome.

The Data Safety Monitoring Committee (DSMC) overseeing OVAL recently conducted a preplanned interim analysis and recommended that the study continue. The DSMC made its decision after reviewing un-blinded data and assessing CA-125 response, measured according to the GCIG criteria. The analysis met the interim pre-specified efficacy criterion of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm in the first 60 enrolled subjects evaluable for CA-125 analysis.

In the previously reported Phase 2 study of VB-111 in platinum resistant ovarian cancer, 58% of the patients treated with VB-111 and paclitaxel demonstrated a CA-125 response. Those patients with a CA-125 response demonstrated a median overall survival of 808 days, versus 351 days for those patients without CA-125 response. OVAL is an international Phase 3 randomized pivotal potential registration clinical trial that is comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer.

The study was designed to enroll approximately 400 patients. Its primary endpoint is overall survival. OVAL is conducted in collaboration with the GOG Foundation Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.