New Study Shows Cigarettes Containing 22nd Century’s Proprietary Tobacco Reduce Smoking and Toxicant Exposure

Independent study using proprietary Very Low Nicotine cigarettes was funded by the FDA and the National Institute of Health

CLARENCE, N.Y.--()--22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that the Cancer Epidemiology Biomarkers and Prevention (CEBP) journal has published a new independent study which found that using 22nd Century’s proprietary Very Low Nicotine tobacco cigarettes “may reduce harm exposure.” Further, “negative smoking behaviors do not increase, and exposure to nicotine and many toxic cigarette constituents likely decrease.”

A group of eight researchers from the Center for Interdisciplinary Research on Nicotine Addiction at the University of Pennsylvania and the Masonic Cancer Center at the University of Minnesota conducted the randomized clinical trial which involved 158 non-treatment-seeking smokers. The researchers concluded that the study’s data provide “further support of reduced smoking and exposure with very low nicotine content cigarettes.”

The study demonstrated that a reduction of nicotine to only moderate levels (0.6 – 0.3 mg nicotine yield) does not appear to reduce smoking and, to the contrary, actually increases cigarette consumption significantly. In contrast, the “use of very low nicotine cigarettes [0.05mg nicotine yield] decreased daily consumption, as well as nicotine and toxicant exposure…” The study references the similar results achieved in the ground breaking clinical trial lead by Donny et al. that was published in the October 2015 issue of The New England Journal of Medicine.

“A moderate reduction in nicotine – something that many big tobacco companies can achieve – appears to have no beneficial effects on smokers’ health, and may in fact lead to increased smoking,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “Conversely, 22nd Century is the only company in the world capable of producing combustible cigarettes containing naturally grown tobacco with 95% less nicotine than conventional cigarettes. Time and again, independent clinical studies clearly show that 22nd Century’s Very Low Nicotine cigarettes have important benefits to smokers who wish to lessen their exposure to nicotine.”

Study scientists in the CEBP journal reported that reduced nicotine content cigarettes “have limited design and constituent information available…” However, with the remarkable increase in research on 22nd Century’s proprietary Very Low Nicotine tobacco, that point was recently resolved in the April 2016 edition of Tobacco Regulatory Science, which published a detailed characterization of 22nd Century’s proprietary variable nicotine level SPECTRUM® research cigarettes and concluded that SPECTRUM cigarettes are an “important tool in clinical studies for investigating… the impact of reduced nicotine cigarettes on nicotine addiction…” See also the Company’s June 16, 2016 press release summarizing the Tobacco Regulatory Science article.

22nd Century’s Vice President for Plant Biotechnology, Dr. Paul Rushton, explained, “Based on an ever-increasing number of scientific publications, a very clear picture has emerged illustrating the significant benefits of our proprietary Very Low Nicotine tobacco. It seems clear that at very low levels of nicotine, people smoke less and are exposed to smaller amounts of toxic constituents. For these reasons, public health officials are beginning to consider public policy changes that could bring 22nd Century’s products to consumers around the world who seek Very Low Nicotine product choices.”

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.

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399

Release Summary

New Study Shows Cigarettes Containing 22nd Century’s Proprietary Tobacco Reduce Smoking and Toxicant Exposure; Independent study was funded by the FDA and the National Institute of Health.

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399