WILLIAMSVILLE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE American:XXII),
a plant biotechnology company that is focused on tobacco harm reduction
and hemp/cannabis research, announced today the results of a recently
completed, company-sponsored study involving 22nd Century’s Very Low
Nicotine Content (VLNC) cigarettes. The results indicate that subjects
using the VLNC product had 97% less nicotine in their blood as compared
to their blood-nicotine levels after use of their usual brand of highly
addictive commercial cigarettes.
22nd Century’s important new study was included in the Company’s
Modified Risk Tobacco Product (MRTP) application, which was previously
submitted to the U.S. Food and Drug Administration (FDA) for 22nd
Century’s VLNC cigarettes under the proposed brand name VLN™. 22nd
Century’s MRTP application seeks the FDA’s authorization to advertise
that VLN™ cigarettes contain 95% less nicotine as compared to the 100
top-selling cigarette brands in the United States.
Nicotine has long been known as the primary addictive chemical in
cigarettes. 22nd Century’s VLN™ cigarettes, with 95% less nicotine, have
greatly diminished nicotine exposure versus conventional cigarettes that
contain highly addictive levels of nicotine. In the recently completed
study, 55 subjects were randomly assigned to each of the following three
products on different days of the study: 1) their usual brand of
cigarettes (containing addictive levels of nicotine), 2) the Company’s
VLN™ cigarettes (containing 95% less nicotine than users’ usual brands
of cigarettes), and 3) nicotine chewing gum. The subjects were allowed
to use each of the products, as much as desired, on different days of
the study; subsequently, after each day of using one of the three
products, each participant’s blood-nicotine level was tested.
When the subjects used VLN™ cigarettes, the nicotine level in their
blood was 97% less than the nicotine level in their blood when they used
their usual brand of cigarettes. In contrast, when the subjects used
nicotine gum, which is a common nicotine replacement therapy, the users’
nicotine level in their blood was only 69% less than when they used
their usual brand of cigarettes.
The study results also showed that the users’ cravings for cigarettes
and urge to smoke were significantly reduced. Overall, the results of
22nd Century’s study suggest that (i) VLN™ cigarettes have a lower
potential for abuse than conventional cigarettes, and (ii) VLN™
cigarettes have a potential for abuse that may be comparable to using
nicotine gum.
“In contrast to the highly addictive cigarettes sold by Big Tobacco
companies, 22nd Century’s VLN™ cigarettes contain 95% less nicotine,”
explained Henry Sicignano III, President and Chief Executive Officer of
22nd Century Group. “22nd Century’s new study joins more than 50
independent scientific studies using our Company’s proprietary VLNC
tobacco and investigating the potential public health benefits of VLNC
cigarettes. Upon FDA approval, we look forward to bringing to market the
world’s first Modified Risk Tobacco Product.”
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/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, 2018, filed on March 6,
2019, 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, Inc.
James Vail, Director of Communications
(716)
270-1523
jvail@xxiicentury.com