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."
About Hepatitis C
According to the WHO, hepatitis C is a major cause of hepatitis and chronic liver disease, including cirrhosis and liver cancer. Globally, an estimated 170 million persons are chronically infected with HCV and 3 to 4 million persons are newly infected each year. HCV is spread primarily by direct contact with human blood. The major causes of HCV infection worldwide are the use of unscreened blood in transfusions, and re-use of needles and syringes that have not been adequately sterilized. Neither a prophylactic nor a therapeutic vaccine is currently available to prevent hepatitis C.
About Pevion Biotech
Pevion Biotech is a privately owned Swiss biopharmaceutical company focusing on the immunological treatment and prevention of infectious diseases and cancer. The company is a leading specialist in the development of efficient and safe vaccines based on its proprietary virosome-based technology platforms. Pevion Biotech’s technology PeviPROTM is approved by regulatory authorities and well established for prophylactic use. Further improvement of the wellaccepted and safe PeviPROTM vaccine technology led to the development of PeviTERTM, which represents Pevion Biotech’s technique for the accelerated development of therapeutic vaccines against chronic infectious diseases and cancer. Pevion Biotech’s development pipeline includes, among others, vaccines against HCV, breast cancer, malaria and candidiasis. Pevion Biotech was founded in 2002 as a joint venture company of Crucell N.V. (Euronext, NASDAQ: CRXL; SWX: CRX) and Bachem AG (SWX: BANB). Located in Bern, Switzerland, the company currently has a staff of 21 scientists.
source - Pharma Live