Inovio partner announces completion of Phase I DNA vaccine study

SAN DIEGO — Inovio Biomedical Corp. announced Nov. 30 that its partner Tripep AB of Sweden has completed its phase I clinical study of its ChronVac-C hepatitis C virus DNA vaccine delivered using Inovio's electroporation technology.

The study established the safety and tolerability of this therapy, with vaccine-induced immune responses and transient effects on the serum levels of hepatitis C virus in these chronically infected patients providing proof-of-concept of DNA vaccines delivered using electroporation. Twelve patients were treated with this combination of Tripep's ChronVac-C DNA vaccine and Inovio's proprietary technology.

In the lowest-dose group, there was no reduction in serum levels of hepatitis C virus (HCV) RNA and no immune responses lasting greater-than or equal to one month were detected. In the medium-dose group, two of three patients showed transient reductions in serum levels of HCV RNA and in the same two patients T-cell responses to the vaccine lasting greater than or equal to one month did appear. In the highest-dose group, three of six patients showed transient reductions in serum levels of HCV RNA and in two of these three patients there were T-cell responses to the vaccine persisting more than one month.

In addition, early data from three patients given standard treatment since completing the clinical trial have experienced rapid reduction of the virus, possibly suggesting a role for such a vaccine in combination with existing approved therapies. Additional patients will be monitored during 2010.

"We are pleased to collaborate with Tripep,” said Dr. J. Joseph Kim, Inovio's president and CEO. “The results of this clinical study will contribute to the advancement of all our programs for DNA vaccines delivered using electroporation, including those for influenza, HIV, cervical cancer and other infectious diseases."

Inovio Biomedical focuses on developing a new generation of vaccines, called DNA vaccines. The company's proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to increase gene expression and immune responses.