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Innogenetics reports significantly improved liver fibrosis in hepatitis C patients after 3 years of therapeutic vaccination
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Innoogenetics Press Release
Gent (Belgium) -- March 25, 2004 -- Innogenetics today announced the 3-year histology data of itsongoing phase 2a study in hepatitis C (HCV) patients, which started in early 2001. After 4 courses of HCV E1-based therapeutic vaccine injections given over a 3-year period in 23 patients, liver fibrosis on average showed significant improvement compared to baseline.
In October 2002, positive histological results were communicated on 24 patients who underwent two vaccination courses followed by liver biopsy. Since then, 24 patients received two further courses of HCV E1-based vaccination over an additional 1.5-year period and 23 patients recently underwent a third liver biopsy. These biopsies have now been analyzed by two expert pathologists, and compared with the baseline biopsy taken 3 years earlier. Histological scoring was performed under strict procedures of blinding.
The key finding that has now emerged is a regression (improvement) of liver fibrosis averagingminus 0.43 points (95% confidence interval [-0.82, -0.05]) on the Ishak fibrosis scale. This resultconstitutes a significant decrease (p = 0.044) from baseline. No less than 87% (20/23) of thepatients either improved (10/23) or remained stable (10/23) in their Ishak liver fibrosis score. This group of patients (mean age at entry 53 years, HCV genotype 1, with active liver disease) were, for the most part, non-responders to previous interferon-based therapy. Such patients would be expected to show a marked progression in liver fibrosis of about + 0.60 to about + 0.99 points on average, as reported in different studies describing the natural fibrosis progression in hepatitis C patients. The present results therefore extend and confirm the previously reported phase 2a results.
According to Professor Dr. F. Nevens (University of Leuven - KUL), the Principal Investigator of this clinical study, "These 3-year study results now show that HCV E1 vaccination was very well tolerated, and suggest that such treatment not only halts disease progression towards liver cirrhosis, but also results in fibrosis regression over the longer term."
Philippe Archinard, CEO of Innogenetics commented: "These very positive 3-year histology results further strengthen and confirm the previous positive trends already observed with our E1 candidate therapeutic vaccine, and this mostly in patients who failed to respond to current standard therapy. These data will certainly lead Innogenetics to vigorously pursue the development of this HCV E1 candidate vaccine in particular, and encourage us to further expand our therapeutic vaccine program in general."
Notes to Editor
The initial phase 2a trial with the HCV E1 candidate vaccine started in the spring of 2001 and involved 35 patients with chronic hepatitis C virus who were infected with genotype 1. Twenty-six patients received five 20-microgram injections of the HCV E1 protein on alum at weeks 0, 4, 8, 12, and 24, while 9 patients received placebo at similar intervals. In the spring of 2002, a study extension was initiated in which 34 of the previously enrolled 35 patients took part. Based on the promising immunological results, all 34 patients received six 20-microgram injections of the same vaccine at 3-week intervals.
Twenty-five patients received two E1 vaccination courses. A total of 24 out of these 25 patients then underwent a liver biopsy after a second vaccination course. In the phase 2a extension study, the 9 placebo patients underwent two courses of E1 therapeutic vaccination, followed by a liver psy, of which the positive liver histology results were communicated in the press release of July 3, 2003. The other 24 underwent a third and fourth vaccination course in 23 of these 24 patients, followed by a liver biopsy, of which the results are covered in this press release.
To date, the phase 2a studies have also demonstrated that the therapeutic candidate vaccine is well tolerated, as supported by the very low dropout rates over 3 years.
Presently, a large European placebo-controlled phase 2b study in 164 patients is ongoing to confirm these findings. The results of this phase 2b study are expected during the second quarter of 2005.
Liver biopsy remains the gold standard to assess liver disease. Histology is the science ofexamining such biopsies.
The Ishak scoring method was used to evaluate the liver fibrosis. This scoring system is a widely accepted tool for the semi-quantitative assessment of liver fibrosis and inflammation in therapeutic trials.
About Innogenetics
Innogenetics is a Belgian-based international biopharmaceutical company building parallelbusinesses in the areas of specialty diagnostics and therapeutic vaccines. In its DiagnosticsDivision, Innogenetics develops a large number of specialty products covering three areas: infectious diseases (hepatitis C, hepatitis B, and HIV), genetic testing (HLA tissue typing and cystic fibrosis), and neurodegeneration (Alzheimer's disease). In 2003, total revenues increased by 16% to €73 million, with specialty diagnostics reaching an operating profit of €7 million. The Company's candidate therapeutic vaccine for the treatment of hepatitis C - a global unmet medical need - is currently considered to be ahead of the competition. With a strong commercially oriented management team and distinctive dual business model, Innogenetics provides a low-risk biotech investment with potentially high returns. Founded in 1985, Innogenetics is listed on Euronext Brussels. Innogenetics' headquarters are in Gent, Belgium, with sales affiliates in the United States, Germany, France, Spain, and Italy. Innogenetics employs 590 people worldwide and has a market capitalization of approximately € 360 million.
For further information, please contact
Jean-Christophe Donck
Vice President Investor Relations
Tel.: + 32 9 329 1701
Fax + 32 9 329 1908
jeandon@innogenetics.com
www.innogenetics.com
SPECIAL NOTE REGARDING FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements that involve risks and uncertainties, including but not limited to projections of future revenues, operating income, and other risks. Prospective investors should be aware that these statements are estimates, reflecting only the judgment of our management, and they should not place undue reliance on any forward-looking statements.
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