Immediate reduction in nicotine content is
the clear winner
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company focused on tobacco harm reduction and Very
Low Nicotine tobacco, announced today that the Journal of the
American Medical Association (JAMA) published results of a greatly
anticipated independent clinical study investigating the effects of
an immediate reduction in nicotine content of cigarettes versus a
gradual reduction in nicotine content of cigarettes. Dr. Dorothy
Hatsukami and other highly respected scientists used exclusively
22nd Century’s SPECTRUM® research cigarettes to conduct this
study.
In this randomized, parallel, double-blind clinical study, which
is the largest clinical study using Very Low Nicotine Content
(VLNC) cigarettes conducted to date, independent scientists
assigned 1,250 participants to one of three groups: (1) smokers who
were provided only with cigarettes containing VLNC tobacco with 0.4
mg of nicotine per gram of tobacco, (2) smokers who were provided
with cigarettes with a gradual reduction of nicotine from 15.5 mg
to 0.4 mg of nicotine per gram of tobacco, and (3) smokers who were
provided with cigarettes of a conventional nicotine level with 15.5
mg of nicotine per gram of tobacco.
This timely trial addresses a key question posed by the FDA in
the Agency’s March 2018 Advance Notice of Proposed Rulemaking
(ANPRM) to lower nicotine in cigarettes to minimally or
non-addictive levels: Which is better for public health… an
immediate or a gradual reduction in nicotine?
Following 2 weeks of baseline study and 20 weeks of
intervention, an immediate reduction in nicotine emerged as the
clear winner. Compared to a gradual nicotine reduction, an
immediate nicotine reduction was associated with:
- Lower toxicant exposure across
time
- Fewer cigarettes smoked per day
- Greater reduction in nicotine
dependence
- More days in which participants smoked
no cigarettes (cigarette-free days)
In contrast, results from those assigned to a gradual reduction
in nicotine were nearly indistinguishable from the results of those
assigned to cigarettes with a conventional level of nicotine in the
areas of dependence, number of cigarette-free days, cigarettes
smoked per day, and most of the biomarkers of nicotine and tobacco
smoke exposure.
In a companion article published by
the University of Minnesota, Dr. Dorothy Hatsukami, Professor of
Psychiatry at the University of Minnesota Medical School, remarked:
“The results support the benefits of rapidly reducing nicotine in
all cigarettes, primarily because this approach helped smokers, who
initially had no immediate intentions to quit, experience
smoke-free days. This is good news because the majority of smokers
want to quit smoking, but only a small percentage of smokers are
successful.”
“The results of this large, independent clinical study
significantly add to the already extensive array of published
clinical studies that have been conducted with 22nd Century’s VLNC
cigarettes,” explained Juan Sanchez Tamurrino, Vice President of
Research and Development at 22nd Century. “The results of Dr.
Hatsukami’s study will serve to strengthen further the case for
VLNC cigarettes to benefit public health even as 22nd Century
finalizes the Company’s revised Modified Risk Tobacco Product
(MRTP) application for our BRAND A Very Low Nicotine cigarettes
that will be submitted to the FDA before the end of this year.”
“The peer-reviewed results of this latest independent clinical
study serve to confirm and expand the knowledge gained through Dr.
Eric Donny’s Randomized Trial of Reduced-Nicotine Standards for
Cigarettes that was published in the October 2015 issue of The New
England Journal of Medicine,” explained Henry Sicignano III,
President and Chief Executive Officer of 22nd Century Group. “With
the data from the many completed, independent clinical studies
using 22nd Century’s VLNTM tobacco and technology, the FDA may
accelerate plans to require that all cigarettes sold in the U.S.
contain only minimally or non-addictive levels of nicotine. To this
end, 22nd Century stands ready to license our non-addictive tobacco
to all tobacco companies that are truly committed to improving the
health of smokers.”
About the 1,250-Patient Phase III Clinical Study
Title: Effect of Immediate vs Gradual Reduction in
Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure
(JAMA. 2018;320(9):880-891. doi:10.1001/jama.2018.11473)
Authors: Dorothy K. Hatsukami, Ph.D.; Xianghua Luo,
Ph.D.; Joni A. Jensen, MPH; Sharon S. Allen, M.D.; Eric C. Donny,
Ph.D., et al.
Funding: Funding for this independent clinical study was
provided by the Food and Drug Administration (FDA) and the National
Institute on Drug Abuse (NIDA)
Summary: A video summarizing the results of this clinical
study is available at:
https://jamanetwork.com/learning/video-player/16749452
Sites: University of Pennsylvania (Philadelphia,
Pennsylvania); Johns Hopkins University (Baltimore, Maryland); Duke
University (Raleigh/Durham, North Carolina); Moffitt Cancer Center
(Tampa, Florida); University of Minnesota (Minneapolis [lead site]
and Duluth, Minnesota); University of Texas MD Anderson Cancer
Center (Houston, Texas); Mayo Clinic (Scottsdale, Arizona);
University of California (San Francisco, California); and Oregon
Research Institute (Eugene, Oregon).
About SPECTRUM® Research Cigarettes
22nd Century developed SPECTRUM® research cigarettes in
partnership with independent researchers and officials from the
National Institute on Drug Abuse (NIDA), the U.S. Food and Drug
Administration (FDA), the National Cancer Institute (NCI), and the
Centers for Disease Control and Prevention (CDC). The main
SPECTRUM® product line, uniquely produced by 22nd Century, consists
of a series of cigarette styles that vary nicotine yields over a
50-fold range – from very low (97% less nicotine than tobacco
contained in conventional cigarette brands) to relatively high
nicotine yields. SPECTRUM® features 24 styles, in both regular and
menthol versions, with 8 different levels of nicotine.
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants and the level of cannabinoids in
hemp/cannabis plants through genetic engineering and plant
breeding. 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 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, 2017, filed on March 7, 2018,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180905005335/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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