Vascular Biogenics’ (VBLT) VB-111 Meets Primary Endpoint in Phase 2 Study
Shares of Vascular Biogenics Ltd. (VBLT) were trading up +2.10 or +52.90 percent to $6.07 per share in Monday’s premarket after news over the weekend that the company’s VB-111 treatment for recurrent glioblastoma met its primary endpoint of a statistically significant increase in median overall survival. Vascular Biogenics stock closed at $3.97, up +0.18 or +4.75 percent in Friday’s regular trading session.
Founded in 2000, Or Yehuda, Israel based Vascular Biologics was formally known as Medicard Ltd, changing its name in early 2003 to Vascular Biogenics.
In a presentation by the company at the annual meeting of the American Society of Clinical Oncology in Chicago, Vascular Biogenics demonstrated a significant survival benefit in patients with recurrent glioblastoma that received VB-111 treatments compared with historical pooled data for treatment with Avastin. The results of the study were released Friday after the market close.
The company noted that VB-111 had met its primary endpoint defined as an increase in median overall survival in the Phase II study. The study showed that overall survival for patients continually exposed to VB-111 was 59 weeks, which compares to 32 weeks for the historical pooled data for Avastin trials. For the twelve month period, survival for patients exposed to VB-111 was 57 percent versus 24 percent for the historical pooled data for patients in Avastin trials.
Yael Cohen, MD, Vice President of Clinical Development at VBL Therapeutics stated in the company’s press release that, “This meta-analysis provides a large dataset from diverse sources, which is pooled together to provide a reliable historical control group; superiority of VB-111 continuous exposure over this control group supports our belief that VB-111 used in combination with Avastin can potentially prolong survival in rGBM compared with Avastin alone.”
Cohen continued saying, “The ongoing Phase 3 randomized controlled GLOBE study of VB-111 in combination with Avastin, which is being conducted in the U.S., Canada and Israel, is proceeding on track and our goal is to conduct an event-driven interim analysis according to the study protocol. While the timing of the interim analysis depends on enrollment and VB-111 activity, we expect to conduct it in the first half of 2017.”
The company’s ongoing pivotal Phase III GLOBE study in recurrent glioblastoma compares the combination of VB-111 with Avastin versus treatment with Avastin alone in 252 patients in Canada, the United States and Israel. The study is proceeding under a Special Protocol Assessment which was granted by the U.S. Food and Drug Administration and has a full endorsement from the Canadian Brain Tumor Consortium. VB-111 has already received orphan drug designation in the United States and Europe and has been granted a Fast Track designation by the FDA to prolong survival in patients with glioblastoma which has recurred after conventional treatments of standard chemotherapy and radiation.
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