Independent Phase II & III Clinical Studies on 22nd Century's Smoking Cessation Technology Highlighted on New Heracles Webs...
May 24 2016 - 10:23AM
Business Wire
Heracles Pharma Seeks to Develop Strategic
Partnerships with Pharmaceutical Industry in Pursuit of FDA
Approval and Commercialization of X-22 Very Low Nicotine Smoking
Cessation Product
22nd Century Group, Inc. (NYSE MKT: XXII), a plant
biotechnology company that is a leader in tobacco harm reduction,
announced today that 22nd Century has launched a new website at
www.heraclespharma.com to highlight the Company’s X-22 Very Low
Nicotine smoking cessation cigarette in development. With 95% less
nicotine than conventional tobacco, X-22 is the first and only
smoking cessation product in the form of a combustible cigarette.
X-22 smokes, tastes and smells like a regular cigarette but is,
based on independent clinical studies, exceptionally effective as a
smoking cessation product. With the goal of ultimately
commercializing X-22 as a prescription-based pharmaceutical
product, 22nd Century’s wholly-owned subsidiary, Heracles
Pharmaceuticals, is the only company in the world with an active
IND (Investigational New Drug) application with the FDA for a
combustible cigarette as a smoking cessation product.
The new Heracles website showcases the extensive clinical
research that has incorporated the Company’s proprietary Very Low
Nicotine tobacco cigarettes, including 8 completed or ongoing
independent Phase II and Phase III clinical studies:
http://heraclespharma.com/clinical-trials/. Each of these clinical
studies includes a link to the study abstract as posted online,
including:
- The 2015 Queen Mary University study
that was supported by a grant from the Global Research Awards for
Nicotine Dependence (GRAND) funded by Pfizer (PFE),
- The landmark clinical study conducted
by Eric C. Donny, Ph.D. et al. – and funded by the FDA – that was
published in the October 2015 issue of The New England Journal of
Medicine, and
- The ongoing Phase III University of
Pittsburg study – also funded by the FDA – that compares an
immediate reduction in nicotine to non-addictive levels (using 22nd
Century’s proprietary Very Low Nicotine cigarettes with 95% less
nicotine) versus a gradual reduction in nicotine to non-addictive
levels (using 22nd Century’s proprietary SPECTRUM® government
research cigarettes).
The new Heracles website also details 22nd Century’s extensive
patent portfolio that protects the Company’s novel technology and
allows it to produce what is, by far, the world’s lowest nicotine
tobacco http://heraclespharma.com/patent-estate/.
Positioned to disrupt the multi-billion dollar smoking cessation
market and to increase the number of smokers willing to try to quit
smoking, X-22 is a six-week treatment that utilizes the Company’s
proprietary Very Low Nicotine tobacco cigarettes to satisfy a
smoker’s craving for cigarettes while separating the act of smoking
from the rapid delivery of nicotine. Containing the same
proprietary tobacco used in the Company’s proprietary Very Low
Nicotine SPECTRUM® government research cigarettes, X-22
significantly reduces cravings with no noticeable withdrawal
symptoms. The product does not expose smokers to any new toxicants
and has no new side effects. Not surprisingly, the idea of a
combustible cigarette that aids in smoking cessation is highly
attractive to smokers who wish to quit.
22nd Century is seeking a strategic pharmaceutical partner to
fund a final Phase III clinical study in order to complete the
Company’s IND application to the FDA for approval of X-22 as a
prescription-based smoking cessation aid. As a matter of
background, in 2007, Cytos Biotechnology AG received a $38 million
up-front payment from Novartis AG (NVS) to conduct a Phase II
scientific study on an experimental smoking cessation vaccine.
Although the study by Cytos later failed, Novartis had agreed to
milestone payments payable to Cytos of up to $600 million. In 2009,
and based on results from just one small Phase II study, Nabi
Biopharmaceuticals received a $40 million up-front payment from
GlaxoSmithKline (GSK) for NicVax, another now failed experimental
smoking cessation product. GlaxoSmithKline had agreed to milestone
payments of up to $500 million to Nabi. In contrast, 22nd Century
seeks a $30 million non-dilutive strategic partner investment based
on the compelling results of seven (7) completed Phase II and Phase
III studies for a prescription-based product made from the
Company’s proprietary Very Low Nicotine tobacco that could prove to
be the world’s most effective smoking cessation aid.
“X-22’s message is both very powerful and incredibly simple,”
explained Henry Sicignano, III, President and Chief Executive
Officer of 22nd Century Group. “Very Low Nicotine cigarettes enable
smokers to sever the act of smoking from the rapid delivery of
nicotine. There are no new behaviors for patients to learn, no
pills, no shots… and, perhaps most importantly, X-22 is highly
attractive to smokers who wish to quit.” Mr. Sicignano explained
further, “Pragmatic medical professionals – including
pulmonologists, cardiologists, and radiation oncologists – have
written 22nd Century in support of 22nd Century’s extraordinary
smoking cessation cigarettes, which is why we are accelerating our
efforts to achieve regulatory approval for X-22.”
Mr. Sicignano further noted as follows: “X-22 is a temporary,
interim product name and is not approved or endorsed by the U.S.
Food and Drug Administration. X-22 is a smoking cessation aid in
development. The FDA has not yet (i) evaluated X-22, (ii) approved
any combustible cigarettes for use in smoking cessation, or (iii)
authorized claims that Very Low Nicotine cigarettes are intended to
diagnose, treat, cure, or prevent any disease. 22nd Century is
seeking a strategic pharmaceutical partner to fund a final Phase
III clinical study in order to complete the Company’s IND
application to the FDA for approval of X-22 as a prescription-based
smoking cessation aid. In the meantime, if circumstances allow,
22nd Century may introduce Very Low Nicotine smoking cessation
cigarettes to markets outside the United States in advance of FDA
approval in the United States.”
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 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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