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.