Innogenetics reports top-line results of placebo-controlled clinical trial with candidate hepatitis C therapeutic E1 vaccine

11-Sep-2007

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Innogenetics announced the top-line results of the second placebo-controlled clinical trial with its viral protein E1-based therapeutic vaccine candidate for patients chronically infected with hepatitis C virus (HCV). The trial was designed to assess safety and efficacy. Results again confirmed both the safety/tolerability of the vaccine candidate as well as its ability to stimulate immune responses. However, the difference between the vaccine and placebo groups did not reach statistical significance for the overall primary efficacy target of slowing down liver tissue damage. Based on these top-line results, the Company has decided to discontinue further investment in the candidate hepatitis C therapeutic E1 vaccine.

The current study was a European prospective multicentre randomized, double-blind, placebo controlled study in 122 patients. In the 3-year clinical trial (157 weeks), patients received four courses of vaccine, which consisted of yeast-derived E1 material at a dosage of 50 micrograms. Liver biopsies were taken at the beginning and at the end of the study. The clinical end-point of the trial was a reduction in liver tissue damage.

The most important outcome parameters of the study have now been analyzed. As in the previous placebo-controlled trial, safety/tolerability of the vaccine were reconfirmed. Patients treated with the vaccine showed a strong immune response against the viral protein E1. However, despite the higher dose and longer vaccination period compared to the previous trial, the difference between the vaccine-treated and placebo group for the primary efficacy criterion of reduction in liver tissue damage (as measured by the total Ishak score), did not reach statistical significance.

Work on the E1 vaccine candidate will therefore be discontinued in favour of the existing promising pipeline of next-generation immune therapeutics, which are based on the most up-to-date rational immune design approaches. The safety results of the present study and the generation of a strong immune response in treated patients support the further development of the Therapeutics pipeline in the fields of hepatitis C, hepatitis B, and human papillomavirus.

https://www.bionity.com/en/news/69545/innogenetics-reports-top-line-results-of-placebo-controlled-clinical-trial-with-candidate-hepatitis-c-therapeutic-e1-vaccine.html