Vascular Biogenics Ltd. (NASDAQ: VBLT) watched its shares get absolutely crushed on Thursday after the firm reported top-line results for its late-stage trial in patients with recurrent glioblastoma. This Phase 3 Globe study was designed to evaluate VB-111 in combination with bevacizumab (Avastin), compared to the bevacizumab control arm.
The study is conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA), with full endorsement by the Canadian Brain Tumor Consortium. VB-111 has received orphan drug designation in the United States and Europe, and it 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.
Unfortunately, the study did not meet its pre-specified primary endpoint of overall survival. What is disappointing here is that Vascular Biogenics had previously produced statistically significant results in Phase 2 for overall survival.
Although Vascular Biogenics is facing a sizeable obstacle at this point, the firm plans on looking at additional indications for the drug.
Dror Harats, M.D., CEO of VBL Therapeutics, commented:
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.
Shares of Vascular Biogenics were last seen down nearly 62% at $2.60 on Thursday, with a consensus analyst price target of $14.75 and a 52-week range of $2.30 to $9.05.