VBL Therapeutics Announces Positive Phase 2a Data for VB-111 in Recurrent Thyroid Cancer

VBL Therapeutics

, a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory disease, today announced positive results from its exploratory Phase 2a study of VB-111 in patients with recurrent, iodine-resistant differentiated thyroid cancer. VB-111 demonstrated disease stabilization and safety in the study, which was designed to assess the compound's safety and signal of efficacy. "We are pleased by the results of this study, which suggest that VB-111 is active in patients with advanced thyroid cancer and provide further proof-of-concept support to the unique mechanism of VB-111 and its potency in recurrent cancer indications," said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. "We are excited to see that VB-111 provided disease stabilization for patients who previously progressed after receiving several lines of treatment, and are encouraged by the compound's continuously favorable safety profile. Going forward, we plan to focus our efforts and resources on our pivotal Phase 3 study of VB-111 in recurrent glioblastoma (rGBM), which we plan to initiate in the first half of 2015." Thirty patients enrolled in the open label, dose-escalating study, most of whom had failed on several therapeutic lines, including tyrosine kinase inhibitors, prior to enrollment. Thirteen patients received a sub-therapeutic single dose of VB-111 at 3X10e12 VPs and seventeen received VB-111 at 10e13 VPs every two months until disease progression. Six patients (35%) in the therapeutic dose cohort (n=17) met the primary endpoint of 6-month progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST), compared to three patients (23%) in the low dose cohort (n=13). VB-111 was well-tolerated in both stages of this study, with no signs of clinically significant safety issues. About Thyroid Cancer: Thyroid cancer occurs in the thyroid gland, a hormone-producing organ at the base of the neck that regulates heart rate, blood pressure, body temperature and weight. According to the National Cancer Institute, there are an estimated 535,000 people currently living with thyroid cancer in the United States, with an estimated 60,000 new cases each year and an estimated 1,850 annual deaths as a result of the disease. The type of treatment depends on the cancer cell type, tumor size and severity of the disease. First-line treatment is surgical removal of the thyroid gland, and is recommended for most patients. Treatment with radioactive iodine after surgery to destroy any remaining thyroid tissue may be recommended for more advanced disease. If radioactive iodine is ineffective, other treatments are prescribed, such tyrosine kinase inhibitors and systemic chemotherapy. However, if such treatments are unsuccessful, the therapeutic options for patients are currently very limited.