Thursday, March 08, 2018 7:27:42 AM
TEL AVIV, Israel, March 08, 2018 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), today reported top-line results from its pivotal Phase 3 GLOBE study in patients with recurrent glioblastoma (rGBM) which was designed to evaluate VB-111 in combination with bevacizumab (Avastin®), compared to the bevacizumab control arm. The study did not meet its pre-specified primary endpoint of overall survival (OS).
Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics, said "We are disappointed that our encouraging Phase 2 data were not replicated in the GLOBE Phase 3 study, and once we receive the full and final data we will be analyzing them carefully to better understand the outcome of the study. We are grateful to the trial investigators, site personnel, patients and caregivers who participated in GLOBE. We believe that VB-111 may still hold promise for other indications we currently or may study in the future.”
Conference Call
Thursday, March 8 at 8:30am Eastern Time
US Investors: 800-239-9838
International Investors: 323-794-2551
Conference ID: 3511679
Webcast: https://edge.media-server.com/m6/p/f7whg6sk
About the GLOBE study
The GLOBE pivotal Phase 3 trial is a randomized, controlled, double-arm, open-label study of VB-111 dosed every two months in combination with bevacizumab dosed every two weeks, compared to bevacizumab monotherapy. Key inclusion criteria include first or second progression of glioblastoma following standard of care treatment with temozolomide and radiation, a histologically confirmed diagnosis of glioblastoma and measurable disease by RANO criteria at progression.
The study is conducted 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 promising and meaningful long-term survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation.
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