First Vaccine for Viral Hepatitis C Could Become a Reality

BERLIN, April 1, 2011 - Early data from phase I trials of an HCV vaccine presented
today at the International Liver Congress(TM) show encouraging results, with
high immunogenicity and good safety profile.(1),(2)

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In the first study[1], a therapeutic T-cell vaccine, based on
novel adenoviral vectors was used on a small population of treatment naive
patients with chronic genotype 1 HCV infection. Intra-muscular vaccination
was administered 2 or 14 weeks into a 48-week course of treatment with
Peg-IFNa2a/ribavirin. 50% of vaccinated patients had CD4+ and CD8+ HCV
specific T-cell responses as detected by ELISpot at 2-8 weeks post boost,
showing a strong immunogenicity for the vaccine. Local and systemic adverse
events to vaccination were mild, with no evidence of liver immunopathology
(measured by liver transaminase levels).

The second study[2] looked at the potential for a prophylactic
vaccine based on similar novel adenoviral vectors technology (
replicative-defective human Ad6 and a novel simian AdCh3 vector that encode
1985 amino-acids derived from the NS3-5 region of a genotype-1b strain). 27
healthy volunteers were vaccinated following a double prime, heterologous
boost strategy. The vaccine induced polyfunctional CD4+ and CD8+ T cells
responses which were maintained up to 52 weeks post prime. Overall
vaccination was very well tolerated with mild/moderate local and systemic
reactions and no serious adverse advents.

Professor Heiner Wedemeyer, EASL's Secretary General
commented: "Vaccines are an exciting area of research now with the potential
to add to the range of treatments available for patients with chronic viral
hepatitis. These are early data but results are very encouraging indeed and
as experts, we look forward to more scientific evidence being made available
to support this new technology as a future treatment option as well as
potentially preventing infection."

Previous research and data presented at the International
Liver Congress shows that vaccination with adenoviral vectors induced highly
potent and durable T-cell responses in healthy human and that similar vectors
may prevent chronic infection in animals.(3) This is the first time the
immunogenicity and safety of vaccination was tested on HCV patients and
healthy subjects.

Notes to Editors

About EASL

EASL is the leading European scientific society involved in promoting
research and education in hepatology. EASL attracts the foremost hepatology
experts and has an impressive track record in promoting research in liver
disease, supporting wider education and promoting changes in European liver
policy.

EASL's main focus on education and research is delivered through numerous
events and initiatives, including:

- The International Liver Congress(TM) (
www.easl.eu/_the-international-liver-congress/general-information)
which is the main scientific and professional event in hepatology worldwide

- Meetings (www.easl.eu/_events) including Monothematic and
Special conferences, Post Graduate courses and other endorsed meetings that
take place throughout the year

- Clinical and Basic Schools of Hepatology (www.easl.eu/_education
), a series of events covering different aspects in the field of hepatology

- Journal of Hepatology (
https://www.easl.eu/members/journal-of-hepatology) published monthly

- Participation in a number of policy initiatives at European level

About The International Liver Congress(TM) 2011

The International Liver Congress(TM) 2011, the 46th annual
meeting of the European Association for the study of the Liver, is being held
at the Internationales Congress Centrum, Berlin, Germany from March 30 -
April 3, 2011. The congress annually attracts over 7,500 clinicians and
scientists from around the world and provides an opportunity to hear the
latest research, perspectives and treatments of liver disease from principal
experts in the field.

References

———————————

[1] Kelly C et al. A therapeutic vaccine for HCV based on novel, rare,
adenoviral vectors. Abstract presented at the International Liver
Congress(TM) 2011. (750)

[2] Barnes E. Phase I trials of a highly immunogenic and durable T-cell
vaccine for Hepatitis C virus based on novel, rare, adenoviral vectors.
Abstract presented at the International Liver Congress(TM) 2011. (2104)

[3] Folgori A et al. A T-cell HCV vaccine eliciting effective immunity
against heterologous virus challenge in chimpanzees. Nature Medicine - 12,
190 - 197 (2006)

Video:
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For further information on the studies, or to request an interview, contact the EASL Press Office: easlpressoffice at cohnwolfe.com; Isabelle Scali: Onsite tel: +44(0)7717-435-103; Vicky O'Connor: Offsite tel: +44(0)20-7331-5342