Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine i...
October 06 2017 - 6:30AM
Business Wire
“Minimally or non-addictive Very Low Nicotine
cigarettes are the ultimate harm reduction strategy”
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company that is focused on tobacco harm reduction,
announced today that Dr. Dorothy Hatsukami, at the Vermont Center
on Behavior and Health’s 5th Annual Conference on Tobacco
Regulatory Science, revealed the fundamental findings of a highly
anticipated 1,250-patient, 20-week study that compared smokers who
were assigned to: i) an immediate reduction to Very Low Nicotine
cigarettes; ii) gradual reduction in reduced nicotine content
cigarettes; or iii) normal nicotine content cigarettes. Designed to
determine which approach produces the most optimal outcomes for
smokers, the announcement of the results of the seminal phase III
study comes only weeks after the United States Food and Drug
Administration (FDA) announced that the Agency is exercising its
authority under the Family Smoking Prevention and Tobacco
Control Act to mandate lower nicotine – at non-addictive levels –
in all combustible cigarettes sold in the United States.
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the full release here:
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22nd Century’s proprietary SPECTRUM®
research cigarettes facilitate independent studies on nicotine
reduction strategies. The FDA plans to mandate lower nicotine – at
non-addictive levels – in all cigarettes sold in the United States.
(Photo: Business Wire)
Dr. Hatsukami, who is the Co-Director of the Center for the
Evaluation of Nicotine in Cigarettes and Professor of Psychiatry
and Director of the Tobacco Research Programs at the University of
Minnesota, led the ground-breaking phase III study that was
conducted in 10 cities across the United States and included
participants from all demographics.
22nd Century was the exclusive provider of the Very Low Nicotine
and other SPECTRUM research cigarettes that were used in Dr.
Hatsukami’s 1,250-participant trial and in more than 16 other
clinical trials. In fact, 22nd Century is the only company in the
world capable of growing tobacco with nicotine levels of just 0.4mg
per gram of tobacco, which is more than a 95% reduction in nicotine
as compared to tobacco in conventional cigarettes. Many scientists
around the world believe that tobacco with this very low level of
nicotine is minimally or non-addictive.
Though the details of Dr. Hatsukami’s phase III study are still
under peer review, Dr. Hatsukami divulged the answer to the study’s
core question of whether an immediate or a gradual reduction in
nicotine is the best approach. Dr. Hatsukami clearly and
confidently declared in her panel presentation at the Vermont
Conference that “an immediate approach [to nicotine reduction] is
most likely to lead to less harm.” Further, Dr. Hatsukami pointed
out that the study data indicates compensatory smoking is less
likely to occur with an immediate reduction in nicotine, and that
the there was a “greater likelihood of more rapid smoking
cessation” with the immediate approach to nicotine reduction.
Following Dr. Hatsukami’s discussion, Dr. Stephen T. Higgins,
Director of the University of Vermont Tobacco Center of Regulatory
Science took the podium and announced to the conference attendees:
“I will present evidence that reducing nicotine content lowers the
addiction potential of smoking among those with psychiatric
conditions or socioeconomic disadvantage consistent with prior
evidence in samples from the general adult smoker population.” In
addition to finding reduced evidence of addiction in smokers of
22nd Century’s Very Low Nicotine Content (VLNC) cigarettes, Dr.
Higgins found that: “VLNCs did not produce evidence of compensatory
smoking.” [emphasis added]
Dr. Jonathan Foulds of Penn State College of Medicine also
delivered a powerful call to action at the conference, challenging
the attending scientists to deny the tobacco industry any
diversions or strategies that could be used to delay the FDA’s
planned mandate to reduce nicotine in cigarettes to very low,
non-addictive levels. Dr. Foulds then pointed out the stakes
involved: “Such a move [by FDA to reduce nicotine content of
cigarettes] could result in one of the largest single improvements
in public health ever [seen] in this country.”
“Considering the results of numerous phase II and phase III
studies that have been conducted with VLN cigarettes, there is now
compelling and conclusive evidence that Very Low Nicotine
cigarettes decrease cigarette dependence, reduce the number of
cigarettes smoked per day, and increase smokers’ quit attempts,”
explained Henry Sicignano III, President and CEO of 22nd Century
Group. “With the power to save millions of lives and to prevent a
new generation of young people from becoming dependent on tobacco,
minimally or non-addictive Very Low Nicotine cigarettes are the
ultimate harm reduction strategy.”
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 cannabis plants. The Company’s primary mission
in tobacco is to reduce the harm caused by smoking. The Company’s
primary mission in 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/20171006005223/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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