Phase II Clinical Trial Featuring 22nd Century’s Very Low Nicotine Tobacco Accepted for Publication
June 17 2015 - 10:58AM
Business Wire
Very Low Nicotine Cigarettes Reduce
Frequency and Urges to Smoke, Help Smokers Quit
22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco
harm reduction, announced today that an independent Phase II
clinical trial conducted at Queen Mary University of London that
explored the efficacy of the Company’s proprietary very low
nicotine tobacco as a smoking cessation aid when combined with
pharmacotherapy has been accepted for publication in Nicotine &
Tobacco Research. The study was supported by a grant from the
Global Research Awards for Nicotine Dependence (GRAND) funded by
Pfizer, Inc.
The results of this study once again confirm the effectiveness
of 22nd Century’s very low nicotine tobacco cigarettes as a smoking
cessation aid. The Company’s very low nicotine cigarettes satisfy
the behavioral aspect of smoking while delivering only trace
amounts of nicotine. Indeed, it is 22nd Century’s fundamental
assertion that very low nicotine cigarettes uncouple the
behavioral/sensory aspects of smoking from the rapid delivery of
nicotine.
The Queen Mary researchers noted: “[Very low nicotine
cigarettes] have been shown to be satisfying... [and] were also
shown to reduce tobacco withdrawal symptoms, including urges to
smoke and low mood.” The clinical trial compared the combination of
very low nicotine cigarettes together with two other treatments: 1)
varenicline (Pfizer’s Chantix), and 2) nicotine replacement
therapies (patches, lozenges, etc.). In each case, 22nd Century’s
proprietary tobacco cigarettes provided smokers with a substantial
boost in their efforts to stop smoking. Despite providing patients
with only a 2-week supply of 22nd Century’s very low nicotine
cigarettes (a separately published Phase II clinical trial used a 6
week treatment period) researchers found that participants who
received very low nicotine cigarettes had higher quit rates at
1-week, 4-weeks, 6-weeks, and at the study’s maximum 12-weeks.
However, due to the size of the study, researchers were unable to
achieve statistically significant results at 6 and 12 weeks.
Although the study refers to 22nd Century’s cigarettes as
“de-nicotinised cigarettes,” or DNCs, 22nd Century does not
“de-nicotinise” or chemically strip tobacco to remove the nicotine.
Instead, the Company’s proprietary very low nicotine tobacco, when
grown and processed in the same manner as conventional tobacco,
contains 95% less nicotine.
As the Queen Mary clinical trial was initiated in 2011,
researchers used 22nd Century’s first generation very low nicotine
tobacco. Accordingly, it is not surprising that these first
generation cigarettes were not well suited to British consumer
tastes. More recently, 22nd Century has developed very low nicotine
tobacco blends designed according to consumer tastes in each of
Europe, Asia, and the Americas that the Company believes will be
very satisfying to smokers.
The Queen Mary trial highlights one of the important
applications of 22nd Century’s proprietary very low nicotine
tobacco. Another application of the novel technology is
demonstrated by 22nd Century’s MAGIC 0 brand (0.04 mg nicotine
yield; a 95% reduction in nicotine) which is the world’s only
tobacco cigarette brand to provide smokers with the choice of a
product which separates the rapid delivery of nicotine from the act
of smoking. Sales of MAGIC 0 brand and MAGIC 2 brand have recently
commenced in Europe and will be available in several additional
countries by the end of 2015. 22nd Century does not represent that
any of its current commercial brands are intended to be used as
smoking cessation aids.
The Queen Mary study concludes: “The most pragmatic approach may
be to offer an ongoing supply of [very low nicotine cigarettes] to
those who want to continue using them.” This conclusion echoes
Former US FDA Commissioner Dr. David Kessler’s recommendation that
“the FDA should quickly move to reduce nicotine levels in
cigarettes to non-addictive levels… It is the ultimate harm
reduction strategy.” Indeed, 22nd Century is deeply committed to
commercializing this approach and remains the only company in the
world capable of producing virtually nicotine-free tobacco.
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 owns or exclusively controls 128 issued
patents and 52 pending patent applications in 96 countries. 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/20150617005941/en/
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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