22nd Century Conducts Three Short-Term Studies in Support of the Company’s MRTP Application to the FDA
June 20 2018 - 9:45AM
Business Wire
Study details available at
www.clinicaltrials.gov
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company that is a leader in tobacco harm reduction
and Very Low Nicotine Content tobacco, announced that the Company
has initiated three short-term studies investigating the behavioral
and biochemical responses to the Company’s proprietary Very Low
Nicotine Content tobacco. 22nd Century scientists will submit to
the FDA the data collected from these studies as part of the
Company’s revised and enhanced Modified Risk Tobacco Product (MRTP)
application for “BRAND A” Very Low Nicotine Content cigarettes.
Slated for submission this year, 22nd Century’s MRTP application
will request a marketing order from the U.S. Food and Drug
Administration (FDA) to allow 22nd Century to disclose to consumers
that the VLN™ tobacco of “BRAND A” cigarettes contains at least 95%
less nicotine than the tobacco in conventional cigarettes.
22nd Century is the only company in the world that has grown
commercial crops of proprietary VLN™ tobacco with nicotine levels
of just 0.4mg per gram of tobacco – a level that has been
recognized by many public health officials as only “minimally or
non-addictive.” Independent clinical trials using 22nd Century’s
proprietary SPECTRUM® research cigarettes have shown that Very Low
Nicotine Content cigarettes “reduce cravings, reduce consumption of
cigarettes, and increase quit attempts.”
As announced by the FDA in July 2017, the FDA is seeking to
dramatically reduce the nicotine levels in all cigarettes for
precisely the same reasons 22nd Century is developing “BRAND A” as
a Modified Risk Tobacco Product. Accordingly, 22nd Century may be
the first company in the world to win FDA approval to market a
combustible cigarette as a “Modified Risk Tobacco Product.”
22nd Century’s clinical studies are designed to confirm and
substantiate further data previously collected by independent
researchers. 22nd Century’s short term studies will expand the
demographic reach of the independent trials, thus demonstrating the
suitability of the Company’s Very Low Nicotine tobacco for a wide
range of smokers.
Summaries for two of the studies, “Evaluation of the Abuse
Liability of Very Low Nicotine (VLN) Cigarettes” and
“Evaluation of the Abuse Liability of Very Low Nicotine (VLN)
Mentholated Cigarettes,” are already posted at
www.clinicaltrials.gov
(https://clinicaltrials.gov/ct2/show/NCT03559751 &
https://clinicaltrials.gov/ct2/show/NCT03559725). The third study,
“A Longitudinal Ambulatory Study to Assess Changes in Cigarette
Consumption Behavior and Biomarkers of Exposure during a 6-Week
Switch to Very Low Nicotine Cigarettes,” will be added soon.
While the FDA is engaged in the rule-making process to limit
nicotine in all cigarettes to minimally or non-addictive levels,
22nd Century’s MRTP application for “BRAND A” Very Low Nicotine
Content cigarettes pursues a complementary and potentially faster
pathway for regulatory approval.
“22nd Century’s team of scientists, regulatory experts, and
specialist consultants are meticulously assembling our revised MRTP
application for “BRAND A” Very Low Nicotine Content cigarettes,”
explained Henry Sicignano, III, President and Chief Executive
Officer of 22nd Century Group. “Later this year, we will submit a
robust MRTP application that answers many of the questions the FDA
is asking with regard to the Agency’s planned national nicotine
reduction mandate. The public deserves – and desperately needs – a
minimally or non-addictive cigarette… sooner, rather than
later.”
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180620005710/en/
22nd Century GroupJames Vail, Director of
Communications716-270-1523jvail@xxiicentury.com
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