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VBL Therapeutics' shares plummet on Phase 3 glioblastoma failure

Published on 09/03/18 at 10:04am

Israeli drug development firm VBL Therapeutics has been left reeling after it announced that its lead oncology product ofranergene obadenovec, or VB-111, had failed to meet its primary endpoint in a Phase 3 study investigating its efficacy when used in combination with Roche’s Avastin (bevacizumab), as opposed to Avastin alone, in the treatment of recurrent glioblastoma (rGBM).

As part of the trial regimen, participants were dosed once every two months with VB-111 and once every two weeks with Avastin, with key inclusion criteria including 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.

Unfortunately, despite VB-111 demonstrating statistically significant overall survival and progression-free survival in a Phase 2 trial in rGBM versus current standard of care, it was found that the combination therapy did not sufficiently improve overall survival. The news sent the company’s shares plummeting by more than 60%.

“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 analysing them carefully to better understand the outcome of the study,” said Dr Dror Harats, Chief Executive Officer of VBL. “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.”

Matt Fellows

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