A therapeutic vaccine for nicotine dependence: Results of a phase I and a randomized phase II study

Abstract

1008 Background: Tobacco consumption remains the most important avoidable cancer risk and smoking causes 90% of all lung cancers. The vast majority of cigarette smokers who try to quit ultimately fail because of high relapse rates. Clearly novel approaches are needed for the treatment and prevention of nicotine addiction. Cytos002-NicQb is a therapeutic vaccine that aims at induction of nicotine specific antibodies that neutralize nicotine in the blood and reduce nicotine uptake into the brain. In this way nicotine will loose its rewarding central effects. This should enable smokers to break their pattern of addiction and protect them from full relapse in case of occasional ‘slips’. Methods: Phase I: 40 healthy non smokers were included in a single center, randomized, placebo-controlled, parallel-group dose comparison study. Phase II: 300 smokers were included in a multicenter, randomized, double-blind, placebo-controlled efficacy study. Primary endpoint of the study is continuous abstinence from smoking in months 4, 5, and 6 after first vaccination. Continuous abstinence is monitored by self reporting, detection of the nicotine metabolite cotinine in urine samples and by detection of CO in exhaled air. Results: Phase I: Safety: In general, vaccination with NicQb was safe and well tolerated. Of the adverse events that were recorded, most were rated as mild (93%), few as moderate and none as severe. Local reactions were the most prominent side effects observed. Some subjects reported flu-like symptoms. Immunogenicity: All subjects immunized with NicQb showed significant anti-nicotine IgG titers (100% response rate). Phase II: Efficacy: Data will be available in Q2, 2005 and will be presented for the first time at the meeting. Conclusions: NicQb is safe, well tolerated and highly immunogenic. Neutralizing the addiction driving nicotine in cigarette smoke by vaccination of the smoker holds promise to significantly reduce avoidable incidents of cancer and other smoking related disease. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Cytos Biotechnology Cytos Biotechnology Chilka Ltd., Cytos Biotechnology