The final 12-month data confirm the trends seen in the previous data at six and nine months for both smoking cessation and long-term smoking abstinence. Importantly, there was no evidence of compensatory smoking or increase in withdrawal symptoms observed in NicVAX patients at any stage of the 12 month trial. NicVAX continued to be well-tolerated with the placebo and NicVAX dose groups showing comparable adverse event profiles at each stage of the clinical study.
These data were presented at the American Heart Association (AHA) Scientific Sessions 2007 in Orlando, Florida by Dr Stephen Rennard, Larson Professor of Medicine, University of Nebraska Medical Center.
Dr Rennard, said: “I believe data from this trial are very encouraging for smokers who are trying to quit as well as for the field of smoking cessation vaccines. Only a short time ago, it was difficult to find convincing evidence to link anti-nicotine antibody with smoking cessation. This trial has demonstrated a clinical proof of concept. The data show there is a correlation between antibody level and the ability of patients to quit smoking and remain abstinent over long periods of time. This development is key for the field of smoking cessation research and could have a significant impact on how we treat patients with nicotine addiction.”