Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that the safety, tolerability and immunogenicity of its therapeutic vaccine for hepatitis C (INO-8000/VGX-6150) will be studied in a phase I clinical trial in chronically HCV infected patients. Under a 2011 collaborative development agreement, Inovio's affiliate, VGX International Inc. (KSE: 011000), is fully funding and conducting the study at multiple sites in Korea. Inovio is also planning to evaluate this hepatitis C (HCV) vaccine in additional clinical studies in the U.S. beginning in 2014.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "More effective antiviral drugs have changed the prognosis for patients with hepatitis C; however, treatment failures remain and combination with an immunotherapeutic approach could make the difference for many patients. In preclinical studies, Inovio's HCV immunotherapy has shown to generate powerful T cell responses in the liver, which could be important in clearing HCV-infected liver cells. We have already shown in published clinical studies that our vaccines generate best-in-class T-cell responses. In this study, the effects of Inovio's HCV immunotherapy will be directly tested in patients who have previously failed standard drug therapies. We look forward to entering the hepatitis C treatment arena, which is one of the fastest-developing markets in healthcare, with a projected value of $20 billion by the end of the decade."
This study is a multi-center, open-label, dose-escalating phase I trial in which 18 subjects will be divided into three groups and given four monthly vaccinations of 1 mg, 3 mg and 6 mg doses of VGX-6150, respectively. Individuals with chronic HCV who failed previous standard of care therapy with pegylated interferon and ribavirin or triple therapy with standard of care and direct-acting antiviral agents such as boceprevir or telaprevir will be enrolled. Both immunogenicity and virologic response will be evaluated in addition to the safety and tolerability of VGX-6150.
VGX-6150 is a SynCon® multi-antigen DNA vaccine covering hepatitis C virus (HCV) genotypes 1a and 1b and targeting HCV nonstructural proteins 3 (NS3) and 4A (NS4A) as well as NS4B and NS5A proteins. VGX-6150 also includes DNA encoding IL-28B to adjuvant the immune response. VGX-6150 will be administered with Inovio's proprietary CELLECTRA® delivery device.
SOURCE Inovio Pharmaceuticals, Inc.