Tripep initiates preparations for a phase I/II study of ChronVac-C® vaccine

Following the advice from the Swedish Medical Products Agency (MPA) Tripep has started the preparations for a phase I/II study of Tripep’s ChronVac-C® vaccine delivered by Inovio’s Medpulser® DDS. An application for approval of a phase I/II study will be submitted to the MPA as soon as possible to enable the study to start during 2007 and be completed during 2008.

”The advice from the MPA means that Tripep in a shorter time frame and at a lower cost can reach ”proof of concept” in man for our combination of ChronVac-C®, delivered by Inovios Medpulser® DDS”, says Tripep’s CEO Jan Nilsson.

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.

In December 2006 Tripep filed an application with the Swedish Medical Products Agency for a phase I clinical study with ChronVac-C® with the intent to commence the phase I study in the spring of 2007. Typically, phase I studies are performed on healthy volunteers with the primary goal of ensuring safety of the drug, i.e. that it does not cause significant adverse effects. Following discussions with the Swedish Medical Products Agency during the spring 2007, Tripep has decided to start the clinical development program of ChronVac-C® with a combined phase I/II study in subjects previously infected with HCV. Phase I/II studies are typically performed in patients who carry the disease which makes it possible to evaluate potential side effects, as well as, efficacy of the drug.

Tripep’s ChronVac-C® vaccine, administered with Inovio’s Medpulser® DDS, has in an animal model proven to selectively wipe out hepatitis C virus protein producing liver cells. 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