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VBL Therapeutics announces first patient enrolled in Europe in the OVAL trial of VB III to treat platinum resistant ovarian cancer.

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Published:31st Dec 2020
VBL Therapeutics announced the expansion of its ongoing OVAL Phase III study investigating ofranergene obadenovec (VB 111), for the treatment of platinum-resistant ovarian cancer into Europe, where the first patient has now been enrolled. The study continues to actively recruit patients in the U.S. and Israel, with over 200 patients enrolled to date. Interim analysis from OVAL demonstrated VB 111’s significant response rate of 58% or higher in the first 60 patients. According to the Company update on November 16, 2020, the high response rate of greater than 50% in the total evaluable patient population was still maintained with approximately 200 patients enrolled. The EU expansion follows two completed analyses by the independent Data Safety Monitoring Committee (DSMC) which recommended to continue the study as planned. The next DSMC review is expected in the first quarter of 2021. About the OVAL study (NCT03398655) : OVAL is an international Phase III randomized pivotal potential registration clinical trial that compares a combination of VB 111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll approximately 400 patients. 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. About VB 111 (ofranergene obadenovec): VB 111 is an investigational, first-in-class, targeted anti-cancer gene therapy agent that is being developed to treat a wide range of solid tumors. VB 111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB III is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in greater than 300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase II studies. VB 111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB 111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. VB 111 successfully demonstrated proof-of-concept and survival benefit in Phase II clinical trials in radioiodine-refractory thyroid cancer VBL Therapeutics Announces First Patient in Europe in the OVAL Trialand recurrent platinum-resistant ovarian cancer (NCT01711970).
Condition: Ovarian Cancer
Type: drug

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