Dramatic Surge in Very Low Nicotine Tobacco Clinical Trials and Science
May 31 2017 - 7:15AM
Business Wire
22nd Century to Meet with FDA Center for
Tobacco Products in June about Proprietary “BRAND A” Very Low
Nicotine Cigarettes
22nd Century Group, Inc. (NYSE MKT:XXII) announced today that
there has been a dramatic surge in the number of publications
relating to the Company’s proprietary Very Low Nicotine (VLN)
cigarettes. The number of in-progress clinical trials using 22nd
Century’s VLN cigarettes is also increasing. There are currently 25
Very Low Nicotine-related clinical trials in progress, which is
almost triple the number of clinical trials completed over the
entire preceding decade. All of these studies are independently
funded by major collaborators on the projects including the
National Institutes of Health (NIH), the U.S. Food and Drug
Administration (FDA), The National Institute of Allergy and
Infectious Diseases (NIAID), The National Institute on Drug Abuse
(NIDA), and The National Cancer Institute (NCI).
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There has been a dramatic surge in the
number of publications relating to 22nd Century's proprietary Very
Low Nicotine (VLN) cigarettes. (Graphic: Business Wire)
Following publication of the landmark clinical study by Eric C.
Donny, Ph.D., et al. in The New England Journal of Medicine, and
the World Health Organization (WHO) Advisory Note entitled “Global
Nicotine Reduction Strategy,” independent scientists have conducted
and published a large and growing number of clinical trials and
recommendations related to 22nd Century’s signature VLN tobacco
technology. In the last sixteen months, there have been 33 new
scientific publications relating to 22nd Century’s VLN tobacco – an
850% increase – reflecting an average of more than 2 new published
papers per month.
The impressive increase in clinical trials utilizing the
Company’s proprietary VLN tobacco has resulted in an increase in
scientific commentaries and opinion pieces as scientists develop
policy recommendations for the use of VLN cigarettes. Nine recent
publications urged policymakers to incorporate Very Low Nicotine
cigarettes as a tobacco control policy tool.
As independent research in 22nd Century’s proprietary Very Low
Nicotine cigarettes surges, 22nd Century scientists are scheduled
to meet in June with the FDA’s Center for Tobacco Products (CTP) to
discuss the Company’s “BRAND A” Modified Risk Tobacco Product
(MRTP) application. 22nd Century’s MRTP application to the FDA
requests that BRAND A packaging and marketing be allowed to
disclose to consumers that the Company’s proprietary Very Low
Nicotine cigarettes reduce smokers’ exposure to nicotine. BRAND A
cigarettes contain less than 0.6 mg nicotine per cigarette and less
than 0.05 mg nicotine yield per cigarette. In each case, this
represents a reduction of at least 95% less nicotine relative to
“Big Tobacco” cigarette brands, including Marlboro®, Camel®,
Newport®, and American Spirit®.
With approximately 277 billion cigarettes manufactured in the
U.S. in 2014 – representing more than $80 billion in sales – the
cigarette market in the United States remains enormous. At present,
however, the United States is completely devoid of any “reduced
exposure cigarette” option. If 22nd Century’s application to the
FDA is successful, the Company’s BRAND A Very Low Nicotine
cigarettes will offer millions of American smokers a distinct
reduced exposure product choice.
“We are looking forward to next month’s FDA meeting for our
BRAND A Very Low Nicotine cigarettes; it is an important milestone
for our Company,” explained Henry Sicignano, III, President and
Chief Executive Officer of 22nd Century Group. “22nd Century is
committed to providing American smokers with the choice of a
Modified Risk Tobacco Product that significantly reduces smokers’
exposure to 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
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 cannabis is to develop
proprietary 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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IRTH Communications for 22nd Century Group, Inc.Investor
Relations:Andrew Haag, 866-976-4784xxii@irthcommunications.com
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