Inovio Pharmaceuticals, a developer of therapeutic and preventive vaccines against cancers and infectious diseases, said its partner ChronTech Pharma (formerly Tripep ), has initiated a phase IIb clinical study of its ChronVac-C DNA vaccine for hepatitis C virus (HCV), delivered by Inovio's proprietary electroporation DNA vaccine delivery technology, in combination with standard of care.
In a phase I clinical trial of ChronVac-C using Inovio's MedPulser electroporation device the therapy resulted in a robust increase in T-cell immune responses against HCV and was safe and well-tolerated. Post-study observation of subjects who completed the protocol and then entered into standard of care (SOC) treatment using interferon and ribavirin showed a complete and rapid viral response (four weeks) in 70% of the participants. More significantly, 83% of the participants who were monitored for an extended period of time, continued to be free of the virus six months after they completed SOC. SOC treatment alone usually results in about 40-50% of patients reaching undetectable virus levels after six months of treatment.
This phase II follow-on trial is an open-label, single-dose, randomized trial of 32 patients to further explore the effect of the ChronVac-C DNA vaccine administered by Inovio's MedPulser electroporation delivery device. The therapy will be given two times, with four weeks in between, followed by SOC treatment after the final vaccine dose in treatment-naïve chronic HCV infected genotype-1 subjects. This trial will assess the level of immune responses, levels of HCV viral load, and further assess the response to the delivery technology. Twenty patients will receive ChronVac-C vaccine delivered with Inovio's electroporation device; the 12-patient comparison group will receive standard-of-care treatment alone.