Independent Phase II and III Clinical Studies on 22nd Century's Smoking Cessation Technology Highlighted on New Heracles Website

CLARENCE, N.Y.–(BUSINESS WIRE)–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: https://heraclespharma.com/clinical-trials/.
Each of these clinical studies includes a link to the study abstract as
posted online, including:

1. 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),
2. 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
3. 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 https://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.
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