Vaccine to treat nicotine addiction achieves proof of efficacy in phase II clinical trial
Cytos Biotechnology AG 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, USA, on behalf of the three Swiss study centres. 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 vaccinetreated 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.
The data show with a high statistical significance (p=0.014) a strong relationship between the induced antibody levels against nicotine (mechanism of action of the vaccine) and the desired clinical effect (continuous abstinence from smoking); and this was irrespective of the unexpected high placebo response observed. The difference of continuous abstinence between the high responder group and the placebo group was highly significant (p=0.004). Overall cigarette consumption in the high responder group was less than half of that seen in the placebo group (p=0.004). Moreover, the average cigarette consumption by those people who did not achieve continuous abstinence was also lower in the high responder group than in the placebo group (p=0.16). The vaccine was safe and generally well tolerated with common side effects being local injection site reactions and flu-like symptoms, which usually resolved within 24 hours.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
