A separate and independent smoking cessation Phase II trial that utilized VLN cigarettes that 22nd Century supplied (containing approximately 95% less nicotine as compared to conventional cigarettes) has recently concluded, and the results are expected to be available in 2012. Over a 6-week treatment period, this 3-arm study evaluated smokers using just VLN cigarettes, just the 21-mg patch and both products concurrently. The results of this Phase II trial will be compared to 22nd Century's Phase II-B trial to determine the variables that optimize cessation, including nicotine content. 22nd Century's management is confident that its VLN cigarettes are a useful tool for smoking cessation and that the results of its Phase II-B trial will be crucial in determining the optimal nicotine content of the company's VLN cigarettes for cessation going forward.
Another independent smoking cessation trial utilizing VLN cigarettes recently concluded, however, subjects in this Phase III trial did not just use VLN cigarettes. Dr. Michael Moynihan, 22nd Century's Vice President of Research and Development, noted, "The New Zealand Heraldreported last week that a 'groundbreaking' study by Auckland University found that smokers offered VLN cigarettes in conjunction with nicotine replacement therapy (NRT) had a higher quit rate than those given just NRT patches, gums or lozenges."
The reduction in cigarette usage in 22nd Century's own Phase II-B clinical trial and in other independent studies suggests a significant opportunity for 22nd Century's VLN cigarettes to potentially obtain a "modified risk" claim under the Tobacco Control Act. The company expects the final regulations for modified risk tobacco products to be issued April 2012 by the U.S. Food and Drug Administration
