Phase III Clinical Trial with 22nd Century’s Very Low Nicotine Cigarettes Names Ten Major Research Institutions as Study Lo...
October 06 2016 - 12:12PM
Business Wire
22nd Century Group, Inc. (NYSE MKT: XXII), a plant
biotechnology company that is a leader in tobacco harm reduction,
announced today that an update has been issued on the pivotal Phase
III study entitled “Strategies for Reducing Nicotine Content in
Cigarettes.” Funded by the National Institutes of Health (NIH) and
led by Eric C. Donny, Ph.D. of the University of Pittsburgh, this
highly significant clinical trial will determine whether the harm
caused by smoking is most effectively addressed by either 22nd
Century’s proprietary Very Low Nicotine Content tobacco cigarettes
(95% less nicotine than conventional cigarettes), or 22nd Century’s
proprietary SPECTRUM tobacco cigarettes that contain progressively
lower nicotine content. The clinical trial update names 10
nationally recognized research centers, including the Mayo Clinic,
the MD Anderson Cancer Center, Duke University, Johns Hopkins
University, the Moffitt Cancer Center, and the University of
California San Francisco. With an estimated enrollment of 1,250
patients, the on-going study is expected to be completed in March
2017. The Company expects the results of this study to accelerate
the governmental approval process of the Company’s “X-22” smoking
cessation product so that millions of lives and billions in
healthcare costs can be saved each year.
“By evaluating 22nd Century’s Very Low Nicotine cigarettes
against 22nd Century’s gradually reduced nicotine cigarettes, the
Donny trial recognizes that reducing smokers’ exposure to nicotine
is a vital public health goal. Contrary to false and misleading
information recently disseminated by short-sellers of 22nd Century
stock, we are confident that our patented technologies will produce
multi-billion dollar products in both the tobacco and the
pharmaceutical industries,” explained Henry Sicignano, III,
President and CEO of 22nd Century Group. “Our Company is recognized
by the National Institute of Health, the World Health Organization,
and public health advocates around the world as absolutely key to
reducing smokers’ exposure to nicotine; independent clinical
studies continue to show that our Very Low Nicotine cigarettes have
the potential to greatly impact public health.”
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 is to reduce the harm caused by smoking.
22nd Century currently owns or exclusively controls more than 200
issued patents and more than 50 pending patent applications around
the world. Visit www.xxiicentury.com and www.heraclespharma.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, 2015, filed on February 18, 2016,
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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Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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