Inovio Product Pipeline: ChronVac-C: Hepatitis C Virus
Product & Indication
This experimental plasmid codon-optimized NS3/4a DNA vaccine is designed to target chronic hepatitis caused by hepatitis C virus (HCV) infection. The vaccine is being delivered using Inovio's MedPulser® DNA Delivery System. The plasmid vaccine is delivered into muscle tissue with the assistance of electroporation with the goal of achieving expression of and T-cell immune responses to the NS3/4A antigen.
Market Potential
Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions and re-use of inadequately sterilized needles and syringes. Globally, an estimated 170 million people are chronically infected with HCV, representing a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the US, while new incidences of HCV have dropped dramatically, an estimated 4.1 million Americans have been infected with HCV, of whom 3.2 million are chronically infected (Centers for Disease Control and Prevention: 2006). The world market for therapies against hepatitis C infections is estimated at more than $2 billion and is expected to grow to more than $8 billion by 2015 (Frost & Sullivan).
Technical
This experimental DNA vaccine consists of a codon optimized NS3/4A gene given by intramuscular injection in patients with chronic hepatitis caused by HCV, genotype 1 infection, with electroporation.
Interim results, reported in May, 2008, noted:
- In the lowest dose group, two patients who completed treatment developed a T-cell response to hepatitis C.
- In the first patient in the middle dose group to complete treatment against hepatitis C virus infection, samples taken before, during and after treatment show that the viral levels in blood successively decreased by more than 95% during treatment. There have been no severe adverse events.
Stage of Development
Phase: I/II, treatment naive patients with chronic hepatitis C virus infections of genotype 1 and with a low viral load. Being conducted by Tripep.
Purpose: Evaluate if the DNA vaccine CHRONVAC-C® is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition, the capability of the vaccine to induce an immune response and the effect on viral load will be studied.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Study Start Date: October 2007
Status: Enrolling
For more information: www.clinicaltrials.gov Identifier: NCT00563173
Commercialization
Vaccine: co-owned by Tripep and Inovio.
Delivery technology: owned by Inovio.