22nd Century Conducts Three Short-Term Studies in Support of the Company’s MRTP Application to the FDA
Study details available at www.clinicaltrials.gov
WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction and Very Low Nicotine Content tobacco, announced that the Company has initiated three short-term studies investigating the behavioral and biochemical responses to the Company’s proprietary Very Low Nicotine Content tobacco. 22nd Century scientists will submit to the FDA the data collected from these studies as part of the Company’s revised and enhanced Modified Risk Tobacco Product (MRTP) application for “BRAND A” Very Low Nicotine Content cigarettes.
Slated for submission this year, 22nd Century’s MRTP application will request a marketing order from the U.S. Food and Drug Administration (FDA) to allow 22nd Century to disclose to consumers that the VLN™ tobacco of “BRAND A” cigarettes contains at least 95% less nicotine than the tobacco in conventional cigarettes.
22nd Century is the only company in the world that has grown commercial crops of proprietary VLN™ tobacco with nicotine levels of just 0.4mg per gram of tobacco – a level that has been recognized by many public health officials as only “minimally or non-addictive.” Independent clinical trials using 22nd Century’s proprietary SPECTRUM® research cigarettes have shown that Very Low Nicotine Content cigarettes “reduce cravings, reduce consumption of cigarettes, and increase quit attempts.”
As announced by the FDA in July 2017, the FDA is seeking to dramatically reduce the nicotine levels in all cigarettes for precisely the same reasons 22nd Century is developing “BRAND A” as a Modified Risk Tobacco Product. Accordingly, 22nd Century may be the first company in the world to win FDA approval to market a combustible cigarette as a “Modified Risk Tobacco Product.”
22nd Century’s clinical studies are designed to confirm and substantiate further data previously collected by independent researchers. 22nd Century’s short term studies will expand the demographic reach of the independent trials, thus demonstrating the suitability of the Company’s Very Low Nicotine tobacco for a wide range of smokers.
Summaries for two of the studies, “Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes” and “Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes,” are already posted at www.clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT03559751 & https://clinicaltrials.gov/ct2/show/NCT03559725). The third study, “A Longitudinal Ambulatory Study to Assess Changes in Cigarette Consumption Behavior and Biomarkers of Exposure during a 6-Week Switch to Very Low Nicotine Cigarettes,” will be added soon. While the FDA is engaged in the rule-making process to limit nicotine in all cigarettes to minimally or non-addictive levels, 22nd Century’s MRTP application for “BRAND A” Very Low Nicotine Content cigarettes pursues a complementary and potentially faster pathway for regulatory approval.
“22nd Century’s team of scientists, regulatory experts, and specialist consultants are meticulously assembling our revised MRTP application for “BRAND A” Very Low Nicotine Content cigarettes,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “Later this year, we will submit a robust MRTP application that answers many of the questions the FDA is asking with regard to the Agency’s planned national nicotine reduction mandate. The public deserves – and desperately needs – a minimally or non-addictive cigarette… sooner, rather than later.”
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.
22nd Century Group
James Vail, Director of Communications
Source: 22nd Century Group, Inc.
Released June 20, 2018