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Favourable Six Months Follow-Up Results From Intercell's Phase II Therapeutic Hepatitis C Program
Date:9/3/2008

- Long term follow up results from chronically infected Hepatitis C patients strongly confirm and exceed positive data obtained earlier in 2008 - Study is the first to show a statistically significant and long-term

antiviral effect of therapeutic Hepatitis C vaccination - Data pave the way and strongly support move into a second generation vaccine formulated with Intercell's adjuvant IC31(R) acting through TLR

activation

VIENNA, Austria, Sept. 3 /PRNewswire/ -- Today, Intercell AG (ICLL) announced the six months follow up data of its exploratory clinical Phase II study targeting treatment-naive Hepatitis C genotype-1 patients. As previously reported in February 2008, in this trial the therapeutic Hepatitis C vaccine (IC41) comprising five synthetic T-cell peptides and Intercell's first-generation poly-Arginine adjuvant (IC30) disclosed a statistically significant reduction of viral load in the blood of chronically infected patients up to 2 weeks after the last vaccination. The current long term follow up results show that this reduction was significantly more pronounced at six months after the final vaccination.

In the open label controlled multicenter Phase II study 50 genotype-1 patients, naive to standard treatment were enrolled for receiving a treatment schedule consisting of 8 intra-dermal IC41 vaccinations in biweekly intervals with topical application of the Toll-like receptor (TLR) agonist imiquimod. The previous analysis of 46 patients at 2 weeks after the last vaccination with IC41 showed already a statistically significant (p=0.001) HCV RNA decline of 0.2 log. The present follow-up data from 33 patients at six months after end of IC41 vaccination revealed an even greater viral load decline of 0.46 log (p=0.001). Interestingly, the virus decline (0.6 log) at the six months time point was most pronounced in patients with high initial viral load (> 2 million copies/ml). A parallel st
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SOURCE Intercell AG
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