Interim analysis approves inclusion of the last three patients for high-dose treatment in the ChronVac-C®-study
After an interim analysis of available data an independent board recommended that the ChronVac-C® study should be expanded to include the last three patients and that they were to receive treatment with the highest dose of ChronVac-C®. This was the dose that gave the most prominent reductions in the viral load. The committee found that there was no evidence for severe or unexpected adverse events and that treatment with ChronVac-C® can activate T cell responses against hepatitis C and that the treatment has antiviral effects in the two highest dose groups.
”The ChronVac-C®study is running extremely well and we are happy that we now have approval to include the last three patients. The committee chose treatment with the highest dose for these three patients since that was the dose-group where the most significant reductions in the viral load of up to 99.7% (2,4log10), i.e. more than 300 times reduction, were observed. We have already started the preparations for a larger subsequent phase II trial. Since the ChronVac-C® trial is an open study we will continuously report on its progress”, says Tripep’s CEO Jan Nilsson.
The total market for medications against hepatitis C infections is estimated by Rodman & Renshaw to be over 4 billion US dollars in 2008 and is expected to grow to over 8 billion US dollars in 2013.
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
About Tripep
Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented technologies. Tripep is focusing on the following research projects; wound healing therapy ChronSeal® and a therapeutic vaccine against Hepatitis C, named ChronVac-C®, plus the RAS® technology platform. The Tripep share is admitted to trade on First North. Remium AB is Certified Adviser for Tripep AB. For more information, please refer to the company’s website: www.tripep.se.
About ChronVac-C®
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.
About the ChronVac-C® clinical trial
The study is conducted at the Infectious Disease Clinic at the Karolinska University Hospital in Huddinge and entails totally 12 patients divided into three dose groups with increasing doses of ChronVac-C®. Each patient receives four ChronVac-C-vaccinations one month apart. After the last vaccination the patients are followed for another six months. The primary aim of the study is to determine the safety of the treatment and no severe adverse events have so far been recorded. Secondary and tertiary aims are to determine immunogenicity and effects on the viral replication, respectively.
In the event of any discrepancy between the Swedish and English versions of this press release, the Swedish version will take precedence.