Tripep has received approval to start a phase I/II study of the ChronVac-C® vaccine as a treatment for chronic infections by the hepatitis C virus
Tripep has received approval to start a clinical phase I/II study of its ChronVac-C® vaccine from the Swedish Medical Products Agency (MPA). The vaccine will be delivered by Inovio’s Medpulser® DDS. The study – the first one in the world where a DNA vaccine against an infectious agent is administered by in vivo electroporation in humans – is expected to start in September-October of 2007. It is also the first study in the world where a DNA vaccine is used to treat hepatitis C.
ChronVac-C® is a therapeutic vaccine, i.e. it is given to individuals already infected by the hepatitis C virus with the purpose of halting the infection by boosting the immune response. Tripep’s ChronVac-C® vaccine, administered with Inovio’s Medpulser® DDS, has in an animal model proven to clear liver cells that produce hepatitis C virus proteins.
“More than 70 percent of the persons infected by hepatitis C become chronic carriers of the virus and will develop a chronic liver infection. The chronic liver infection enhances the risk of developing liver cancer and cirrhosis. Now we initiate the first study in the world in humans where a DNA vaccine against an infectious agent is being administered by in vivo electroporation. As we have reported previously, this technology has worked out very well in all models that have been evaluated, and it is pleasing that we after only 18 months of collaboration with Inovio are able to start clinical studies in humans”, says Tripep’s CEO Jan Nilsson.
The study will be conducted at the Department of Infectious Diseases and the Department of Gastroenterology and Hepatology at Karolinska University Hospital in Huddinge and Solna, and it will include four groups with a total of 12 infected patients that will be treated with different doses of ChronVac-C®. The main purpose of the study is to show the safety of the treatment, but also to test if the treatment boosts the host immune response to hepatitis C, as well as a preliminary study on the effects on the virus replication. The total market for therapies against hepatitis C infections is estimated to over 2 billion dollars and is expected to grow to more than 8 billion dollars by 2015 according to Datamonitor.
For more information, please contact:
Jan Nilsson, CEO, Tripep AB
Tel: +46 8 449 84 80, mobile phone: +46 70 466 31 63, E-mail: jan.nilsson@tripep.se
Anders Vahlne, Head of Research, Tripep AB
Tel: +46 8 5858 1313, mobile phone: +46 709 28 05 28, E-mail: anders.vahlne@ki.se