22nd Century Ships 2.4 Million SPECTRUM® Cigarettes for the National Institute on Drug Abuse
November 30 2017 - 12:45PM
Business Wire
XXII’s Proprietary Very Low Nicotine
research cigarettes demonstrate the feasibility of FDA’s plan to
dramatically reduce nicotine in cigarettes
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company focused on tobacco harm reduction and
hemp/cannabis research, announced today that the Company shipped
2.4 million SPECTRUM® research cigarettes for the National
Institute on Drug Abuse (NIDA), which is part of the National
Institutes of Health (NIH).
As a subcontractor under federal government contracts, 22nd
Century has supplied the Company’s proprietary SPECTRUM® research
cigarettes for NIDA since 2011. The SPECTRUM® product line consists
of a series of 24 cigarette styles (11 regular and 13 menthol
versions) that have 8 different levels of nicotine – from very low
to high.
The U.S. Food and Drug Administration (FDA) and other agencies
of the U.S. federal government have invested more than $100 million
in numerous independent clinical studies that have demonstrated the
public health benefits of 22nd Century’s proprietary Very Low
Nicotine Content (VLNC) tobacco cigarettes. As a result of this
research, scientists have found that VLNC cigarettes reduce
cravings, reduce consumption of cigarettes, and increase quit
attempts.
A seminal study was recently completed with 22nd Century’s
SPECTRUM® research cigarettes. This independent Phase III study
featured 1,250 participants at 10 study locations, including the
Mayo Clinic, the Johns Hopkins University, Duke University, the
University of Texas MD Anderson Cancer Center, the University of
Pittsburgh, the University of Minnesota, the University of Vermont,
the University of California – San Francisco and others, all in
collaboration with NIDA. The completed Phase III study compared two
different approaches to help smokers lose their addiction to
nicotine: an immediate reduction in nicotine content in cigarettes
to non-addictive levels versus a gradual reduction in nicotine
content in cigarettes to non-addictive levels. Although the results
of this highly anticipated clinical trial are still in peer review
prior to being published, a principal investigator in the trial,
Dr. Dorothy Hatsukami, has already publicly disclosed that an
immediate reduction in nicotine is “most likely to lead to less
harm.” This announcement came only weeks after the FDA announced
that the Agency is exercising its authority under the Family
Smoking Prevention and Tobacco Control Act to mandate lower
nicotine – at minimally or non-addictive levels – in all
combustible cigarettes sold in the United States.
“22nd Century’s SPECTRUM cigarettes have facilitated dozens of
independent studies that have demonstrated, conclusively, the
public health benefits of minimally or non-addictive cigarettes,”
explained Henry Sicignano, III, President and Chief Executive
Officer of 22nd Century Group. “What’s more, 22nd Century’s
proprietary Very Low Nicotine cigarettes show that the FDA’s plan
to mandate dramatically reduced nicotine levels in cigarettes is
immediately feasible. We are proud to be a part of this
exceptionally important public health initiative.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on genetic
engineering and plant breeding which allows the increase or
decrease of the level of nicotine in tobacco plants and the level
of cannabinoids in hemp/cannabis plants. The Company’s primary
mission in tobacco is to reduce the harm caused by smoking. The
Company’s primary mission in hemp/cannabis is to develop
proprietary hemp/cannabis strains for important new medicines and
agricultural crops. Visit www.xxiicentury.com and
www.botanicalgenetics.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, including but not limited to our future revenue
expectations. 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
fiscal year ended December 31, 2016, filed on March 8, 2017,
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/20171130005870/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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