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Pevion Biotech Announces Its Hepatitis C Therapeutic Vaccine Enters Clinical Phase I
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BERN, Switzerland, Dec. 18, 2006 - Pevion Biotech announced the start of phase I clinical testing of its virosome-based hepatitis C virus (HCV) vaccine. The therapeutic HCV vaccine is based on Pevion Biotech`s proprietary PeviPROTM and PeviTERTM technologies and will be tested for its safety and immunogenicity.
Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPROTM and PeviTERTM platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTERTM) together with a supportive helper T cell response (PeviPROTM). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.
The phase I single-blind randomized placebo-controlled dose escalating study will be conducted under the lead of Professor Dr. med. Giuseppe Pantaleo at the Vaccine and Immunotherapy Center at the University Hospital in Lausanne, Switzerland, and comprises 30 healthy volunteers. The primary goal of the study is to examine the safety and tolerability of the synthetic vaccine. Secondary objectives include assessments of the vaccine's immunogenicity.
In the course of the study, each subject will receive multiple injections. During the clinical trial the volunteers will be closely monitored. The study is scheduled for completion by end of 2007.
Peter Klein, CEO of Pevion Biotech, comments: "More than half of all HCV-infected patients do not experience significant long-term benefits from the current standard therapy using Interferon in combination with antiviral drugs. However, the very promising therapeutic vaccine approach of Pevion Biotech, which is aiming at a cellular immune-response, aims a new dimension of an effective therapy for patients suffering from chronic hepatitis C."
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