Initial results from 22nd Century's X-22 Phase II-B smoking cessation trial

22nd Century Group, Inc. (OTCBB: XXII), a company focused on smoking cessation and tobacco harm reduction products, today announced X-22, a prescription smoking cessation aid in development consisting of very low nicotine (VLN) cigarettes, showed a reduction of smoking from baseline over the 6-week treatment period in the company's Phase II-B clinical trial. Also, the median number of cigarettes smoked was significantly reduced to 11% of baseline (89% reduction) during the 4-week abstinence period.

However, there was no statistically significant difference compared to the active control, a cigarette containing conventional nicotine levels. A preliminary assessment of the Phase II-B trial data also showed that X-22 did not meet its primary endpoint; there was no statistical difference in quitting during the 4-week abstinence period between X-22 and the active control. The two and three-month follow-up periods of the trial are ongoing. As with other clinical trials utilizing VLN cigarettes, there were no serious adverse events attributable to X-22 and the product was well-tolerated.

"These preliminary quitting results are puzzling when compared to results of other independent studies using our VLN product," stated Joseph Pandolfino, 22nd Century's CEO. "We are in the process of evaluating the reasons for the unexpected data from our trial, including the real possibility that we may have gone slightly too far in reducing the nicotine content of X-22."

Previous independent smoking cessation trials, all of which increased cessation, utilized VLN cigarettes containing 22nd Century's proprietary VLN tobacco with a 95% nicotine reduction as compared to conventional cigarettes; the version of X-22 used in 22nd Century's Phase II-B clinical trial contained 97% less nicotine. "Although this appears to be an insignificant difference, it equates to the X-22 version having approximately half of the nicotine of VLN cigarettes utilized in these previous studies," Mr. Pandolfino explained.

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 Herald reported 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 (FDA).