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Hepatitis E Vaccine Shows Promise

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clinical trialsFeb. 28, 2007 -- An experimental hepatitis E vaccine shows promise but needs further study, experts report in The New England Journal of Medicine.

Hepatitis E is a liver disease caused by the hepatitis E virus, which spreads through contaminated food or water.

Hepatitis E is rare in the U.S., but it's a major public health problem in developing countries. The disease is most dangerous for pregnant women, who can die or have miscarriages or stillbirths due to hepatitis E.

pevion biotechBERN, 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.

Intercell AGVienna (Austria), December 12, 2006 - Intercell AG (VSE, "ICLL") announced   today that it has completed a Phase II trial for its therapeutic Hepatitis C vaccine (IC41), where the vaccine was applied in combination with the standard Hepatitis C therapy (pegylated Interferon and Ribavirin - PegIFN- RBV) to patients infected with genotype 1. In the study, the vaccine  administration was bound to the schedule of the first patient trial  concluded in 2004 where route and frequency was still sub-optimal as  compared to the improved induction of pivotal T cells achieved in recently  concluded optimization trial.

In the current clinical trial, chronically infected Hepatitis C patients receiving standard therapy with PegIFN-RBV were enrolled in Germany, Austria and in the UK. 22 patients who had an early response at week 12 to standard therapy received vaccinations with IC41 as an add-on to standard therapy during the second half of their treatment (week 28 to 48). 

dynavaxDynavax Technologies Corporation (Nasdaq: DVAX) announced today positive results from a Phase 2 trial comparing two different vaccination schedules of HEPLISAV, its hepatitis B virus (HBV) vaccine. The primary endpoint is comparative seroprotection after the second dose.

The data was reported today in a poster at the Canadian Immunization Conference in Winnipeg, Manitoba, Canada by Dr. Scott A. Halperin, Professor of Pediatrics and Microbiology and Immunology at Dalhousie University and Head of Pediatric Infectious Disease at the Halifax-based IWK Health Center.

Dynavax shares rocket on hepatitis B vaccine data

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dynavaxSAN FRANCISCO (MarketWatch) -- Dynavax Technologies Corp. shares soared as much as 44% Wednesday to reach their highest level ever after the company said its experimental hepatitis B vaccine protected all of the patients it tested in a late-stage clinical trial.

Shares of the Berkeley, Calif.-based drugmaker (DVAX) were changing hands for $9.96 in afternoon trading, up $2.56 and off an earlier high of $10.66.

Dynavax said that after three doses, its Heplisav vaccine protected 100% of a "difficult-to-immunize" population of adults aged 40 to 70 years compared with GlaxoSmithKline PLC's (GSK) Engerix-B vaccine, which was found to protect 73.1% of such people. In those ranging from 56 to 70 years of age, Heplisav's rate of protection was similarily 100% vs. a 56.1% rate for Engerix-B.