VBL Therapeutics Announces Overall Survival Data For VB-111 Monotherapy In Phase 2 Study For Recurrent Thyroid Cancer

  • The study met its primary endpoint, demonstrating disease stabilization and safety, along with a dose-response
  • Newly released data show evidence of an overall survival benefit for patients treated with therapeutic dose of VB-111

TEL AVIV, Israel, Nov. 29, 2016 (GLOBE NEWSWIRE) --   VBL Therapeutics (NASDAQ:VBLT), today announced top-line results from its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer. As previously announced, this trial met its primary endpoint, which was defined as 25% progression-free survival at 6 months (PFS-6), in heavily-pretreated patients with late-stage disease. A dose-dependent response was seen, with 35% of patients reaching PFS-6 in the therapeutic dose cohort, versus 25% in a low-dose cohort. Given this positive clinical response, the Company continued to follow patients for overall survival (OS) data, which was not a primary endpoint. Although the trial included a small number of patients and was not powered to show OS differences, the new data show a dose-response and evidence of an overall survival benefit in the cohort of patients treated with multiple therapeutic doses of VB-111, compared to patients who received a single low dose of VB-111 (mOS 761 days versus 469 days; p=0.096).  Only one patient remained alive in the low-dose cohort, compared to a tail of about 50% in the high dose group.
VB-111 Tyroid OS

A photo accompanying this release is available at  http://www.globenewswire.com/NewsRoom/AttachmentNg/37de2b1f-1875-448f-a865-025fc63f92e7

"The appearance of dose-dependent superior overall survival provides encouragement, especially given that this trial enrolled patients with late-stage disease whose tumors were resistant to multiple lines of previous therapies," said Keith C. Bible, MD, PhD, Professor of Oncology, Division of Medical Oncology, Department of Oncology, and Endocrine Malignancies Disease Oriented Group, Mayo Clinic Cancer Center, and Primary Investigator for this trial.

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