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Thursday, 06/01/2017 10:22:31 AM

Thursday, June 01, 2017 10:22:31 AM

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22nd Century Group Receives Order for 2.4 Million SPECTRUM(R) U.S. Government Research Cigarettes
Today 9:45 AM ET (Business Wire)Print

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is focused on tobacco harm reduction and cannabis research, announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, received a new purchase order for agencies of the U.S. federal government for 2.4 million of the Company's proprietary SPECTRUMresearch cigarettes. SPECTRUMbrand cigarettes are an important tool in clinical research for investigating the impact of reduced nicotine levels for cigarette addictiveness and cessation success. As recently reported, scientists have dramatically increased the number of clinical trials investigating the important applications of Very Low Nicotine cigarettes. New and on-going independent clinical trials have increased demand for 22nd Century's proprietary SPECTRUM research cigarettes.
In-progress clinical research incorporating the use of SPECTRUMcigarettes includes: (i) exposure studies comparing how different nicotine levels in cigarettes affect smoking behavior, (ii) smoking cessation studies, and (iii) studies to determine the nicotine addiction threshold of cigarettes. Most notable is a newly completed, but not yet published, Phase III study featuring 1,250 participants and funded by the National Institute on Drug Abuse (NIDA). This study is comparing two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels versus a gradual reduction in nicotine content in cigarettes to non-addictive levels. This seminal Phase III study is expected to determine the nicotine reduction approach that demonstrates the most favorable outcomes for smokers; no matter which approach prevails, 22nd Century's Very Low Nicotine tobacco and technology will be a key component.
22nd Century developed SPECTRUMin partnership with independent researchers and officials from the 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 SPECTRUMproduct line, which can only be 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 conventional brands) to relatively high nicotine yields. SPECTRUMfeatures 24 styles, in both regular and menthol versions, with 8 different levels of nicotine in its tobacco. 22nd Century is the only company in the world capable of producing the Very Low Nicotine SPECTRUMbrand styles.
Including this new order, Goodrich Tobacco has received orders for more than 24 million SPECTRUMcigarettes. SPECTRUMcigarettes are not sold commercially; they are produced by 22nd Century for exclusive use in independent clinical research.
"Today there are at least 25 ongoing clinical trials using 22nd Century's proprietary Very Low Nicotine cigarettes," explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. "We expect that this new order of SPECTRUM research cigarettes will facilitate critical additional research... and will ultimately lead to 22nd Century making Very Low Nicotine cigarettes available to smokers around the world."
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