Inovio Pharmaceuticals, Inc. (INO) announced the release of preliminary clinical trial results by its collaborator ChronTech AS of their open label phase II clinical study of ChronVac-C, ChronTech's vaccine to treat hepatitis C virus infection. The study investigated the use of the ChronVac-C DNA vaccine administered with Inovio's MedPulser-DDS electroporation device followed by a drug regimen in chronic HCV positive subjects. The initial results do not show a statistically significant difference so far between treatment outcomes of the vaccinated and non-vaccinated groups. The vaccinated group did display an excellent safety profile.
In the 29 patient phase II study, 17 patients were treated with two monthly vaccinations of ChronVac-C followed by interferon and ribavirin. In the control arm, 12 patients were treated with interferon and ribavirin alone. ChronTech has now made a first analysis 12 weeks after treatment. HCV viral load reduction or elimination is assessed by measuring HCV RNA levels. At treatment week 12, 71% of the pre-vaccinated group had less than 15 international units of HCV RNA compared to 58% in the non-vaccinated group; 65% were HCV RNA negative compared to 58% in the non-vaccinated group. There were no serious adverse events and the number of patients with moderate adverse events was statistically lower in the pre-vaccinated group than in the non-vaccinated group. There was no difference in mild adverse events between the groups.
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