Hepatitis C Virus
Inovio collaboration for ChronVac-C® hepatitis C vaccine
MilestonePhase II interim data reported
ChronVac-C®, developed by ChronTech Pharma AB, is a codon-optimized NS3/4A DNA vaccine targeting chronic hepatitis C virus (HCV) genotype 1a. It is injected into muscle tissue and followed by electroporation using Inovio's MedPulser® DNA Delivery System, with the goal of achieving expression of and T-cell immune responses to the NS3/4A antigen.
ChronTech is conducting an open label phase II clinical study to test the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for ChronVac-C® administered intramuscularly in combination with electroporation followed by interferon and ribavirin in treatment naïve patients (32) with chronic HCV virus genotype 1a with a low viral load. In an earlier phase I study, 83% of the participants who received this treatment cleared the virus.
Hepatitis C virus is a disease characterized by inflammation of the liver. HCV is spread primarily by direct contact with human blood; the major causes worldwide are the use of unscreened blood transfusions and re-use of inadequately sterilized needles and syringes. About 5% of infected persons may die from the consequences of long term infection that leads to liver cancer or cirrhosis. Chronic hepatitis C has been notoriously difficult to treat, with a prevalence exceeding 170 million worldwide. An estimated 5 million people are living with chronic HCV in the U.S.
In March, 2011, Inovio’s partner, ChronTech Pharma AB, initiated a Phase II 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 the standard of care at that time.
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.
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 those participants (5 of 7 patients). More significantly, 83% of the participants (5 of 6 patients) 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.
Hepatitis C virus (HCV) is a disease characterized by inflammation of the liver. HCV is spread primarily by direct contact with human blood; the major causes worldwide are the use of unscreened blood transfusions and re-use of inadequately sterilized needles and syringes.
Most people who were recently infected with HCV do not have symptoms; about 10% have yellowing of the skin (jaundice) that gets better. HCV infections pose a significant global public-health problem and are a major cause of chronic liver disease, liver cancer or cirrhosis.
Most of those infected with HCV develop a long-term, or chronic, infection. An estimated 170 million people worldwide are living with chronic HCV; 5 million of these cases are in the U.S. Usually there are no symptoms. If the infection has been present for many years, the liver may be permanently scarred, a condition called cirrhosis. In many cases, there may be no symptoms of the disease until cirrhosis has developed. About 5% of infected persons may die from the consequences of long term HCV infection.
HCV has been notoriously difficult to treat. The goals of current HCV treatment are to remove the virus from the blood and reduce the risk of cirrhosis and liver cancer that can result from long-term HCV infection. Many patients with hepatitis C benefit from treatment with medications. The most common medications are a combination of pegylated interferon alfa, delivered by weekly injection, and ribavirin, an antiviral medication that can cause birth defects.
Patients who develop cirrhosis or liver cancer may be candidates for a liver transplant. However, HCV usually comes back after a liver transplant, which can lead to cirrhosis of the new liver.