FDA Authorizes Clinical Trial for 22nd Century’s BRAND B Low Tar-to-Nicotine Ratio Cigarettes
May 01 2017 - 6:55AM
Business Wire
22nd Century’s Proprietary Brand B
Cigarettes Will be a Modified-Risk-Tobacco-Product
Candidate
22nd Century Group, Inc. (NYSE MKT: XXII),
announced today that the U.S. Food and Drug Administration (FDA)
has granted 22nd Century authorization to conduct a clinical trial
studying the Company’s BRAND B, low tar-to-nicotine ratio
cigarettes. This trial is designed to confirm that as smokers make
the adjustment to a higher nicotine cigarette, they take in less
smoke because the nicotine is more readily available. 22nd Century
has engaged a Contract Research Organization with extensive
experience in combustible cigarette exposure studies to conduct the
BRAND B trial this summer.
According to the Centers for Disease Control and Prevention
(CDC), 32% of smokers (nearly 12 million) do not wish to quit
smoking. For these smokers, 22nd Century is developing its BRAND B
Low Tar-to-Nicotine ratio cigarettes as a reduced exposure product
candidate. The Company intends to submit a Modified Risk Tobacco
Product (MRTP) application to the FDA for Brand B. Independent
surveys have shown that even though 30-50% of American smokers are
not committed to quitting, 90% of these smokers would be willing to
try a potentially reduced exposure tobacco product. For this
reason, 22nd Century believes the Company’s proprietary BRAND B
product has enormous market potential.
“Our initial clinical trial investigating the effects of BRAND
B’s design-objective – the reduced delivery of smoke components,
other than nicotine – is a measurable step forward in the
development of our Company’s mission,” explained Dr. Michael
Moynihan, Vice President of Research & Development at 22nd
Century Group.
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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version on businesswire.com: http://www.businesswire.com/news/home/20170501005507/en/
22nd Century GroupInvestor Relations:IRTH CommunicationsAndrew
Haag, 866-976-4784xxii@irthcommunications.com
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