Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

06-Oct-2017 Intellasia | BusinessWire | 5:30 PM Print This Post

“Minimally or non-addictive Very Low Nicotine cigarettes are the
ultimate harm reduction strategy”

CLARENCE, N.Y.–(BUSINESS WIRE)–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.


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.

Contacts

22nd Century Group
James Vail, 716-270-1523
Director of
Communications
jvail@xxiicentury.com

 


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