VBL brain cancer drug flunks Phase 3
- Vascular Biogenics Ltd., known commercially as VBL Therapeutics, announced Thursday morning that its lead compound, VBL-111, failed in a Phase 3 combination study with Avastin for advanced brain cancer patients.
- The Israeli biotech, traded publicly on the NASDAQ, saw its shares sink more than 60% in morning trading to linger under $3 per share.
- The company didn't give details on the data, but said the Phase 3 open-label study of VBL-111 with Avastin, compared with Avastin alone, did not meet its primary endpoint of overall survival for patients with recurring glioblastoma.
Glioblastoma is the predominant form of brain cancer. It affects about 12,000 to 13,000 people in the U.S. every year, but has a very poor prognosis. Most patients succumb to the disease within 12 to 15 months after diagnosis. Progression of the disease usually occurs within six months of surgery, chemo and radiation treatment in virtually all patients and most have an overall survival of only six to eight months after that.
This aggressive form of cancer had a spotlight shone on it last year when it was revealed that Arizona Senator John McCain had been diagnosed.
"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," said CEO Dror Harats in a statement.
The company intends to continue to study VBL-111 in other indications. The drug has shown promise in mid-stage studies in other kinds of cancer, including radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer.
Efforts to find a treatment for glioblastomas have largely unsuccessful. A study published in the journal Neuro-Oncology last July showed that even those drugs that posted positive results in Phase 2 largely failed in Phase 3. The study authors looked at treatments across 25 years of study.
"Seven Phase III clinical trials in newly diagnosed glioblastoma and 4 Phase III clinical trials in recurrent glioblastoma met the inclusion criteria. Only 1 (9%) Phase III study documented an improvement in overall survival and changed the standard of care," the study authors wrote.
- VBL Therapeutics Statement
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