The New England Journal of Medicine Publishes Landmark Study Using 22nd Century’s Proprietary Very Low Nicotine Cigarettes
October 02 2015 - 8:56AM
Business Wire
22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco
harm reduction, announced that The New England Journal of Medicine
has published a special article describing a milestone study that
used the Company’s proprietary SPECTRUM research cigarettes
(N Engl J Med 2015;
373:1340-1349). The Center for the
Evaluation of Nicotine in Cigarettes led the double-blind,
parallel, randomized clinical trial involving 840 smokers at ten
locations. The authors concluded that data from the study suggests,
as compared with cigarettes of conventional nicotine content, 22nd
Century’s proprietary low nicotine SPECTRUM cigarettes were
“associated with reductions in smoking, nicotine exposure, and
nicotine dependence, with minimal evidence of nicotine withdrawal,
compensatory smoking, or serious adverse events.”
The study, which was funded by the National Institute on Drug
Abuse (NIDA) and the U.S. Food and Drug Administration (FDA) Center
for Tobacco Products, included six styles of 22nd Century’s
SPECTRUM research cigarettes. The SPECTRUM cigarettes had nicotine
contents ranging from 15.8 mg per gram of tobacco (similar to
commercial brands) to 0.4 mg per gram (“very low nicotine”). The
very low nicotine SPECTRUM cigarettes contain 95% less nicotine
than conventional cigarettes. 22nd Century is the only company in
the world capable of growing tobacco with such low nicotine
content.
Researchers found that during the 6th and final week of the
trial, participants who were assigned 22nd Century SPECTRUM
cigarettes with 0.4 mg/g nicotine smoked fewer cigarettes per day
(14.9) than those assigned to their usual brand (22.2). In fact,
very low nicotine cigarettes were found to reduce exposure to, and
dependence on, nicotine and to reduce cravings while adverse events
were generally mild and similar among groups. Moreover, in the 30
days following the trial, smokers of very low nicotine cigarettes
reported they attempted to quit smoking at a rate double that of
participants who smoked cigarettes with 15.8 mg/gram nicotine
(34.7% vs. 17%).
The study’s lead author, Dr. Eric Donny, explained in an article
posted on usatoday.com, "The evidence is getting stronger that
reducing nicotine reduces smoking and makes people less addicted to
cigarettes and, in doing so, might make them more likely to quit."
To further test this theory, 22nd Century’s proprietary SPECTRUM
cigarettes are being used in a Phase III clinical study that
follows 1,250 smokers for five months (ClinicalTrials.gov NCT02139930).
The results of previous studies using very low nicotine
cigarettes have demonstrated a host of desirable outcomes including
reduced smoking, reduced nicotine exposure, reduce nicotine
dependence, increased abstinence, reduced exposure to toxicants and
few adverse events with little evidence of withdrawal-related
discomfort or safety concerns. Unlike “light” cigarettes (as
previously labeled and marketed by conventional tobacco companies)
which reduce machine-smoking nicotine yields by diluting the smoke
rather than by reducing the nicotine content of the tobacco itself,
very low nicotine cigarettes do not result in compensatory
smoking.
In the past 8 years, the prospect of reducing the addictiveness
of cigarettes has received renewed attention from numerous health
organizations, including the Institute of Medicine, the World
Health Organization (WHO) and the Office of the U.S. Surgeon
General. The Tobacco Control Act, enacted in 2009, granted the FDA
authority to set standards that reduce the nicotine content of all
cigarettes sold in the United States.
“The current study by Donny and colleagues adds to a growing
literature supporting the feasibility and potential benefits of a
national nicotine reduction policy…” explained public health policy
reform advocates, Drs. Michael Fiore and Timothy Baker in a
companion article in the same issue of the NEJM. “Reducing the
nicotine content of combustible tobacco to levels that will not
sustain dependence seems to us to be the most promising regulatory
policy option for preventing [at least] 20 million premature
deaths.”
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants through genetic engineering and plant
breeding. The Company’s mission is to reduce the harm caused by
smoking. 22nd Century currently owns or exclusively controls more
than 185 issued patents and more than 50 pending patent
applications around the world. The Company’s strong IP position led
to a licensing agreement with British American Tobacco (“BAT”), the
world’s second largest tobacco company. Visit www.xxiicentury.com
for more information.
Cautionary Note Regarding Forward-Looking Statements: This press
release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc.,
its directors or its officers with respect to the contents of this
press release. The words “may,” “would,” “will,” “expect,”
“estimate,” “anticipate,” “believe,” “intend” and similar
expressions and variations thereof are intended to identify
forward-looking statements. We cannot guarantee future results,
levels of activity or performance. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that we may issue in the future. Except as required by applicable
law, including the securities laws of the United States, we do not
intend to update any of the forward-looking statements to conform
these statements to reflect actual results, later events or
circumstances, or to reflect the occurrence of unanticipated
events. You should carefully review and consider the various
disclosures made by us in our annual report on Form 10-K for the
year ended December 31, 2014, filed on February 6, 2015, including
the section entitled “Risk Factors,” and our other reports filed
with the U.S. Securities and Exchange Commission which attempt to
advise interested parties of the risks and factors that may affect
our business, financial condition, results of operation and cash
flows. If one or more of these risks or uncertainties materialize,
or if the underlying assumptions prove incorrect, our actual
results may vary materially from those expected or projected.
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version on businesswire.com: http://www.businesswire.com/news/home/20151002005376/en/
Investor Relations:For 22nd Century GroupAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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