Innogenetics Reports Top-line Results of Second Placebo-controlled Clinical Trial with Candidate Hepatitis C Therapeutic E1 Vaccine
GENT (Belgium) – September 7, 2007 - Innogenetics announced today 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.
The general direction of Innogenetics remains unchanged, but the soon-to-be spun off Therapeutics entity will place more emphasis on flexibility for early partnering to achieve its long-term objectives. The current results will not have an impact on Diagnostics.
Commenting on these results, Frank Morich, CEO of Innogenetics, said: "Despite this setback, we intend to pursue the development of our next generation of immune therapeutics including our HCV polyepitope and HCV human monoclonal antibodies through our soon-to-be spun-off Therapeutics entity. Through appropriate partnering, we expect to turn these exciting, well-designed therapeutic candidates into successful products. Finally, let me stress that Innogenetics is one of the few companies in Europe that can fully develop and produce safe therapeutic vaccine candidates. The outstanding efforts and mature potential of our entire Therapeutics Division should therefore be fully appreciated."
Innogenetics is an international biopharmaceutical company building parallel businesses in the areas of specialty diagnostics and therapeutic vaccines.
In 2006, total revenues (product sales, royalties, and license fees) reached €53.7 million. Its Diagnostics Division develops a large number of specialty products covering five areas: infectious diseases (hepatitis C, hepatitis B, HIV, and HPV), genetic testing (cystic fibrosis), tissue typing (HLA), neurodegeneration (Alzheimer’s disease), and cancer. In its Therapeutics Division, Innogenetics focuses on the development of therapeutic vaccines to address unmet medical needs in the field of infectious diseases.
Founded in 1985, Innogenetics is listed on Euronext Brussels [Ticker: INNX]. Innogenetics’ headquarters are in Gent, Belgium, with sales subsidiaries in France, Germany, Italy, Spain, Brazil, and the United States and an associate in the United Kingdom. Innogenetics employs 495 people worldwide and has a market capitalization of approximately €255 million.
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Forward looking statement
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 judgments and projections of Innogenetics’ management, and no undue reliance should be placed on such forward-looking statements.
Posted: September 2007