22nd Century Group Inc., a company focused on smoking cessation and
tobacco harm reduction products, 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 per
cent 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 per cent nicotine reduction
as compared to conventional cigarettes; the version of X-22 used in 22nd
Century's phase II-B clinical trial contained 97 per cent 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,” Pandolfino
explained.
A separate and independent smoking cessation phase II
trial that utilized VLN cigarettes that 22nd Century supplied
(containing approximately 95 per cent 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 US Food and Drug Administration
(FDA).
22nd Century is committed to the X-22 development
programme and continuing to assist the public health community,
including the FDA, in determining how different nicotine levels in
cigarettes affect cessation and smoking behaviour, including whether
there is a threshold level of nicotine in which cigarettes do not
produce dependence. The New York Times recently reported that 22nd
Century is supplying SPECTRUM cigarettes to the US government. SPECTRUM
contains various levels of nicotine and is solely for research purposes.
22nd Century believes the findings from studies conducted with SPECTRUM
will be an important factor in determining tobacco public policy.
22nd
Century Limited, a plant biotechnology company whose proprietary
technology allows for the level of nicotine (and other nicotinic
alkaloids) in the tobacco plant to be decreased or increased through
genetic engineering and breeding.
