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Vaccine to Treat Nicotine Addiction Achieves Proof of Efficacy in Phase II Clinical Trial

By Pharmaceutical Processing | May 17, 2005

Cytos Biotechnology AG recently announced that its vaccine candidate CYT002-NicQb to treat nicotine addiction has achieved proof of efficacy. The phase II clinical trial results were presented by Prof. Dr. Jacques Cornuz (CHUV Lausanne), principal investigator, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, FL on behalf of the three Swiss study centers. The study included 341 smokers and assessed safety, tolerability and efficacy of the vaccine candidate.

Efficacy of the vaccine was determined by continuous abstinence from smoking between week 8 and 24 after treatment start and was measured by self-reporting of the participating smokers and by independent biochemical validation.

Two thirds of the smokers received the vaccine, whereas one third received placebo. All smokers who received the vaccine mounted an anti-nicotine antibody response, which corresponds to an immunological response rate of 100%. Based on the measured levels of antibodies, the vaccine-treated smokers were grouped into a high, a medium, and a low responder group. All smokers who received placebo had no measurable anti-nicotine antibodies in their blood.

Prof. Dr. Jacques Cornuz commented: “I am very excited about the outcome of this study, as the data clearly suggest that antibodies against nicotine are effective in helping people quit smoking. There is certainly no doubt that new approaches such as vaccination are urgently needed. Despite the fact that smoking causes 30% of all cancer deaths, including 87% of deaths from lung cancer, there are 1.3 billion smokers worldwide. And each smoker looses on average more than 10 years of lifetime as a result from this serious addiction. I believe that the vaccine approach has the potential to dramatically alter the way how we will treat smoking addiction in the future.”

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