Vascular Biogenics Ltd (VBLT)

[gr8db8]

VB-111 demonstrates a clear 2-fold efficacy benefit over Avastin alone

http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-newsArticle&ID=2113957

VBL Therapeutics Announces Significant Improvement of 12 Month Overall Survival With VB-111 Compared to Pooled Data From Four Avastin(R) Studies at the Annual Meeting of the Society for Neuro-Oncology
TEL AVIV, Israel, Nov. 19, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced the presentation of new data on its lead oncology product VB-111, a first-in-class, targeted, anti-angiogenic gene-therapy agent with applicability for multiple solid tumor indications, at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), being held in San Antonio, Texas, showing significant improvement of 12 month overall survival (OS) with VB-111 in recurrent Glioblastoma multiforme (rGBM) compared to pooled data from four different Avastin® studies.

VB-111 is being featured in a poster presentation at SNO as well as in a satellite symposium sponsored by the company, both taking place Friday, November 20. New data are being presented that compare the 12 month overall survival achieved with VB-111 in rGBM to the results from four different trials of bevacizumab (Avastin®)1 in this disease setting (n=233). In the recently completed Phase 2 study, the overall survival rate for patients treated with VB-111 in combination with bevacizumab upon disease progression (continuous exposure cohort) was 57% at 12 months. This compares with an overall 12 month survival of 28% (range 16% to 38%) in the pooled data from the 4 Avastin™ studies (p = 0.007).

"This new analysis comparing our VB-111 results with multiple historical studies in rGBM demonstrates a clear 2-fold efficacy benefit," stated Yael Cohen, M.D., Vice President, Clinical Development of VBL Therapeutics. "While there are limitations with comparing results across different clinical trials, this comparison gives us additional confidence in the treatment benefit of VB-111 in this patient population."

"We are now actively recruiting patients in the Phase 3 GLOBE study of VB-111 in combination with bevacizumab and our goal is to have interim data in the first quarter of 2017," continued Dr. Cohen. "We believe that VB-111 has the potential to change the treatment paradigm for rGBM patients, who are at great need for an effective therapy."

VBL's pivotal Phase 3 GLOBE study in rGBM which started in August 2015, is comparing VB-111 in combination with bevacizumab to bevacizumab alone and is recruiting about 252 patients in the US, Canada and Israel. The study is proceeding under a Special Protocol Assessment (SPA) granted by the FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). VB-111 has received orphan drug designation in the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation.