Enrolment to the phase I/II-clinical trial testing ChronVac-C® for the treatment of chronic hepatitis C virus infection has started
As of yesterday, Monday the 29th of October, the enrolment of patients started for the phase I/II clinical trial of Tripeps ChronVac-C® vaccine delivered with Inovio’s Medpulser® DNA Delivery System (DDS), in patients with chronic hepatitis C virus infections. After completion of the initial screening the treatment will commence. The study encompasses a total of 12 treatment naive patients with chronic hepatitis C virus genotype 1 infections and with a low viral load. The patients are divided into four dose groups and each patient will receive a total of 4 monthly vaccinations and then monitored for another six months.
”We are very pleased that enrolment for the first human study on the ChronVac-C vaccine has started as planned” says Tripeps CEO Jan Nilsson.
ChronVac-C® is a therapeutic vaccine, i.e. it is given to individuals already infected with the hepatitis C virus with the aim to clear the infection by boosting the immune response against the virus. Tripep’s ChronVac-C® vaccine is administered with Inovio’s Medpulser® DDS®.
The study will be conducted at two sites at the Karolinska University Hospital; at the Infectious Disease Clinic (Huddinge) and the Centre for Gastroenterology (Solna). 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 that the treatment is safe. The study will also show if the treatment boosts the host immune response to hepatitis C, as well as its effects on the virus replication. The total market for therapies against hepatitis C infections is estimated to be 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