22nd Century Receives Guidance from FDA on Phase III Clinical Trials
June 22 2017 - 9:55AM
Business Wire
Company plans to commence Phase III trials
for “X-22” smoking cessation product in 2018
22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology
company that is a leader in tobacco harm reduction, announced today
that on June 20, 2017, the Company and its wholly owned subsidiary,
Heracles Pharmaceuticals, participated in a meeting with the
multi-discipline review team in the Division of Anesthesia,
Analgesia, and Addiction Products at the Center for Drug Evaluation
and Research (CDER) of the U.S. Food and Drug Administration (FDA)
regarding the Company’s Investigational New Drug Application (IND)
for 22nd Century’s X-22 prescription-based smoking cessation
product in development so that it may become available for doctors
to prescribe to help their patients to stop smoking. The meeting
with the FDA/CDER was very positive and productive. FDA/CDER and
the Company will work to reach agreement on the Company’s design
and implementation of two parallel, Phase III clinical trials to be
conducted by the Company in various parts of the United States to
show that the Company’s X-22 prescription-based smoking cessation
product will result in a more robust quit rate in smoking as
compared to existing smoking cessation products that are already in
the market in the U.S. The Company believes that it will be able to
achieve such robust results.
Henry Sicignano, III, President and Chief Executive Officer of
22nd Century Group, stated, “The mission of our Company is to
reduce the harm caused by smoking and we believe that we can help
smokers to successfully stop smoking through the use of our novel
X-22 smoking cessation product in development. We look forward to
working collaboratively and closely with the FDA during 2017
regarding the approval of important aspects of the two parallel,
Phase III clinical trials on X-22 that we intend to commence in the
first half of 2018, subject to our determination of whether we will
use funds from a third-party or Company funds to conduct such
clinical trials. The public health implications of a smoking
cessation product that is more robust in effectiveness than other
existing smoking cessation products is enormous. We look forward to
continuing to work closely with the FDA on this very important
public health matter.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on genetic
engineering and plant breeding which allows the increase or
decrease of the level of nicotine in tobacco plants and the level
of cannabinoids in cannabis plants. 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 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, 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/20170622005665/en/
22nd Century GroupInvestor Relations:IRTH CommunicationsAndrew
Haag, 866-976-4784xxii@irthcommunications.com
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