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In this randomized, parallel, double-blind clinical study, which is the largest clinical study using Very Low Nicotine Content (VLNC) cigarettes conducted to date, independent scientists assigned 1,250 participants to one of three groups: (1) smokers who were provided only with cigarettes containing VLNC tobacco with 0.4 mg of nicotine per gram of tobacco, (2) smokers who were provided with cigarettes with a gradual reduction of nicotine from 15.5 mg to 0.4 mg of nicotine per gram of tobacco, and (3) smokers who were provided with cigarettes of a conventional nicotine level with 15.5 mg of nicotine per gram of tobacco.
This timely trial addresses a key question posed by the FDA in the Agency’s March 2018 Advance Notice of Proposed Rulemaking (ANPRM) to lower nicotine in cigarettes to minimally or non-addictive levels: Which is better for public health… an immediate or a gradual reduction in nicotine?
Following 2 weeks of baseline study and 20 weeks of intervention, an immediate reduction in nicotine emerged as the clear winner. Compared to a gradual nicotine reduction, an immediate nicotine reduction was associated with:
- Lower toxicant exposure across time
- Fewer cigarettes smoked per day
- Greater reduction in nicotine dependence
- More days in which participants smoked no cigarettes (cigarette-free days)
In contrast, results from those assigned to a gradual reduction in nicotine were nearly indistinguishable from the results of those assigned to cigarettes with a conventional level of nicotine in the areas of dependence, number of cigarette-free days, cigarettes smoked per day, and most of the biomarkers of nicotine and tobacco smoke exposure.
In a companion article published by the University of Minnesota, Dr. Dorothy Hatsukami, Professor of Psychiatry at the University of Minnesota Medical School, remarked: “The results support the benefits of rapidly reducing nicotine in all cigarettes, primarily because this approach helped smokers, who initially had no immediate intentions to quit, experience smoke-free days. This is good news because the majority of smokers want to quit smoking, but only a small percentage of smokers are successful.”
“The results of this large, independent clinical study significantly add to the already extensive array of published clinical studies that have been conducted with 22nd Century’s VLNC cigarettes,” explained Juan Sanchez Tamurrino, Vice President of Research and Development at 22nd Century. “The results of Dr. Hatsukami’s study will serve to strengthen further the case for VLNC cigarettes to benefit public health even as 22nd Century finalizes the Company’s revised Modified Risk Tobacco Product (MRTP) application for our BRAND A Very Low Nicotine cigarettes that will be submitted to the FDA before the end of this year.”
“The peer-reviewed results of this latest independent clinical study serve to confirm and expand the knowledge gained through Dr. Eric Donny’s Randomized Trial of Reduced-Nicotine Standards for Cigarettes that was published in the October 2015 issue of The New England Journal of Medicine,” explained Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group. “With the data from the many completed, independent clinical studies using 22nd Century’s VLNTM tobacco and technology, the FDA may accelerate plans to require that all cigarettes sold in the U.S. contain only minimally or non-addictive levels of nicotine. To this end, 22nd Century stands ready to license our non-addictive tobacco to all tobacco companies that are truly committed to improving the health of smokers.”
About the 1,250-Patient Phase III Clinical Study
Title: Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure (JAMA. 2018;320(9):880-891. doi:10.1001/jama.2018.11473)
Authors: Dorothy K. Hatsukami, Ph.D.; Xianghua Luo, Ph.D.; Joni A. Jensen, MPH; Sharon S. Allen, M.D.; Eric C. Donny, Ph.D., et al.
Funding: Funding for this independent clinical study was provided by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA)
Summary: A video summarizing the results of this clinical study is available at: https://jamanetwork.com/learning/video-player/16749452
Sites: University of Pennsylvania (Philadelphia, Pennsylvania); Johns Hopkins University (Baltimore, Maryland); Duke University (Raleigh/Durham, North Carolina); Moffitt Cancer Center (Tampa, Florida); University of Minnesota (Minneapolis [lead site] and Duluth, Minnesota); University of Texas MD Anderson Cancer Center (Houston, Texas); Mayo Clinic (Scottsdale, Arizona); University of California (San Francisco, California); and Oregon Research Institute (Eugene, Oregon).
About SPECTRUM® Research Cigarettes
22nd Century developed SPECTRUM® research cigarettes in partnership with independent researchers and officials from the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC). The main SPECTRUM® product line, uniquely produced by 22nd Century, consists of a series of cigarette styles that vary nicotine yields over a 50-fold range – from very low (97% less nicotine than tobacco contained in conventional cigarette brands) to relatively high nicotine yields. SPECTRUM® features 24 styles, in both regular and menthol versions, with 8 different levels of nicotine.
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 hemp/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 hemp/cannabis is to develop proprietary hemp 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, 2017, filed on March 7, 2018, 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.