On February 21, 2017 VBL Therapeutics (NASDAQ:VBLT), reported full results from its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer (Press release, VBL Therapeutics, FEB 21, 2017, View Source [SID1234517778]). The data will be presented today by Dror Harats, M.D., CEO of VBL Therapeutics, at the Federation of the Israel Societies for Experimental Biology (FISEB) conference in Eilat, Israel. Schedule your 30 min Free 1stOncology Demo! The primary endpoint of the trial, defined as 6-month progression-free-survival (PFS-6) of 25%, was met with a dose response. Forty-seven percent (47%; 8/17) of patients in the therapeutic-dose cohort reached PFS-6, versus 25% (4/12) in the sub-therapeutic cohort, both groups meeting the primary endpoint. Reduction in tumor measurement after the first dose was seen in 44% (7/16) of patients in the therapeutic-dose cohort, compared to 9% (1/11) in the sub-therapeutic-dose cohort. An overall survival benefit was seen with a tail of more than 40% at 3.7 years for the therapeutic-dose cohort (mOS 684 days). This is similar to historical data for pazopanib* (Votrient), a tyrosine kinase inhibitor; however, most patients in the VB-111 study had tumors that previously had progressed on pazopanib or other kinase inhibitors.
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"We are encouraged to see dose-dependent responses and an overall survival benefit with VB-111 monotherapy, in thyroid cancer patients with end-stage disease whose tumors had not responded to multiple lines of therapies, including kinase inhibitors," said Dr. Dror Harats, CEO. "This trial, together with our Phase 2 trials showing promise for VB-111 in recurrent glioblastoma and platinum-resistant ovarian cancer, point to the potential therapeutic application of VB-111 across multiple solid tumors. We look forward to advancing VB-111 towards commercialization, through our ongoing Phase 3 pivotal GLOBE trial in rGBM and our planned Phase 3 trial in ovarian cancer," added Dr. Harats.
The open-label dose-escalating study enrolled patients with advanced, recently-progressive, differentiated thyroid cancer that was unresponsive to radioactive iodine, in two cohorts. Most patients had tumors that had not responded to multiple therapies prior to enrollment, including radiation and kinase inhibitors. In the first cohort, thirteen patients received a single intravenous infusion of VB-111 at a sub-therapeutic dose of 3X1012 viral particles (VPs). The second cohort included seventeen patients, who received VB-111 at a therapeutic dose of 1013 VPs every two months until disease progression. One patient proceeded from a single low dose to receive later multiple high doses at progression and was included in both groups (for PFS only). VB-111 was well-tolerated in this study, with no signs of clinically significant safety issues.
About the Federation of the Israel Societies for Experimental Biology (FISEB)
ILANIT/FISEB is a federation of 31 Israeli societies of experimental biology. ILANIT’s conference is held every three years in Eilat, with attendance by researchers and students. This year’s conference, taking place February 20-23, is the culmination of the most exciting research performed in Israel in many disciplines. For more information, refer to View Source
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. 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. There are an estimated 1,850 annual deaths in the U.S. as a result of the disease. This subset of patients has an unmet need for novel therapeutic options.