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Hepatitus C Therapeutic Vaccine: study data released
  This information was reported by the company, Immunogenetics, developing the HCV therapeutic vaccine. So the positive announcement should be put into context until further confirmation from independent review is available. Jules Levin
Innogenetics announces additional positive liver histology results for its hepatitis C therapeutic vaccine
Gent, Belgium - July 3, 2003 - On the occasion of the 38th Annual Meeting of the European Association for the Study of the Liver (EASL), Innogenetics today announced the presentation of additional positive results supporting the previously published positive histological findings of its E1-based therapeutic candidate vaccine for hepatitis C.
As part of its phase IIa study that started in 35 chronic hepatitis C patients, positive histological results were communicated in October 2002 for 24 out of the 26 patients who underwent two vaccination courses followed by liver biopsy. The 9 remaining patients have now completed two courses of Innogenetics' E1 candidate therapeutic vaccine and have undergone liver biopsy. These biopsies have now been analyzed by two expert pathologists, and compared with the biopsy at study start, some 28 months before. Histological scoring was performed under strict procedures of blinding.
The results showed that for 78% (7/9) of the patients, the overall Ishak histology score either improved (3/9) or remained stable (4/9) as compared to pre-study scores. Another significant finding was that on average, a regression (improvement) of liver fibrosis of minus 0.22 points on the Ishak fibrosis scale was observed. Over the 28 months since the initiation of the study, this group of patients was expected to have shown, on average, a progression (worsening) of fibrosis, amounting to plus 0.75 points. These results are an independent confirmation of the previously reported phase IIa results in 24 patients, and strengthen the evidence that the E1 therapeutic vaccine may not only halt, but actively induce regression of HCV-related liver disease. In summary, we can state that after two courses of E1-based therapeutic vaccination in a total of 33 (24 + 9) patients, an improvement of liver histology was seen in 12 patients (37%), while the overall Ishak score was stabilized in another 14 patients (42%).
According to Professor Dr. F. Nevens, the principal investigator, "These new liver biopsy results, obtained in the same rigorously monitored manner as previously, strengthen the evidence that the E1-based therapeutic vaccine not only has the potential to halt disease progression towards liver cirrhosis, but appears to demonstrate a possible anti-fibrotic effect."
Beyond these interim results of the phase IIa extension study, the entire cohort of patients is scheduled to receive further E1 therapeutic vaccination in the coming months. This open-label extension of the phase IIa study will generate relevant clinical data over a 3-year period. Its aim is to further explore the long-term disease-modifying effects of E1-based therapeutic vaccination. The next liver histology results on the other 24 patients of this phase IIa extension study are expected in the second quarter of 2004.
According to Philippe Archinard, Chief Executive Officer of Innogenetics, "These outstanding results strengthen the previous positive results already achieved with our E1 candidate therapeutic vaccine, and this mostly in patients who failed to respond to current standard therapy. We eagerly await the outcome of our two ongoing phase II studies, with the fullest confidence that the therapeutic vaccine approach will provide a well tolerated, practical, and effective option for the treatment of HCV patients."
Notes to Editor
The initial phase IIa trial started in the spring of 2001 and entailed 35 patients with chronic hepatitis C virus of genotype 1. Twenty-six patients received five 20-microgram injections of the 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. Thus, 25 patients received two vaccination courses. A total of 24 out of these 25 patients then underwent a liver biopsy after the second vaccination course. In the phase IIa extension study, the 9 placebo patients underwent two course of E1 therapeutic vaccination, followed by a liver biopsy, of which the results are covered in this press release. The other 24 are undergoing a third and fourth vaccination course, followed by a liver biopsy with results expected in the second quarter of 2004.
To date, the phase II studies have also demonstrated that the therapeutic candidate vaccine is well tolerated, as supported by the very low dropout rates over at least 28 months.
Liver biopsy remains the gold standard to assess liver disease. Histology is the science of examining such biopsies.
The Ishak scoring method was used to evaluate the liver histology. A histological improvement or worsening is characterized by a change of at least two points according to the overall Ishak scale (i.e. sum of liver inflammation and fibrosis scores). The Ishak score is a widely accepted tool for the semi-quantitative assessment of liver biopsies in therapeutic trials.
About Innogenetics
Innogenetics is an international biotechnology company building two businesses in the areas of speciality diagnostics and therapeutic vaccines. The Company's advanced therapeutic vaccine for the treatment of hepatitis C virus - a global unmet medical need - is currently considered to be two years ahead of the competition. In its diagnostics division, Innogenetics develops a large number of speciality products covering 3 disease areas: infectious diseases, genetic testing, and neurodegeneration. In 2002, diagnostics sales increased by 17% to 47 million and total revenues reached 62 million. 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 has been listed on NASDAQ Europe since 1996 and on Euronext Brussels since December 2002. The Company's headquarters are in Gent, Belgium, and it has sales affiliates in France, Germany, Italy, the Netherlands, Spain, and the USA. Innogenetics employs 600 people worldwide and has a market capitalization of approximately 300m.
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