In a Phase I clinical trial of ChronVac-C using Inovio’s MedPulser electroporation device the therapy resulted in increase in T-cell immune responses against HCV and was safe and well-tolerated.
The 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.
The 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.
ChronTech Pharma CEO Anders Vahlne said if they can repeat the Phase I results in the phase IIb study there is certainly a possibility that vaccination with ChronVac-C before drug therapy could become a part of the standard of care therapy for patients with chronic hepatitis C-virus infection.
"In particular, we hope that vaccination with this novel therapy will result in a considerable shortening of the duration of interferon and ribavirin treatment," Vahlne said.