Phase II Clinical Trial Featuring 22nd Century’s Very Low Nicotine Tobacco Accepted for Publication

Source:  22nd Century Group, Inc.

Very Low Nicotine Cigarettes Reduce Frequency and Urges to Smoke, Help Smokers Quit

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today that an independent Phase II clinical trial conducted at Queen Mary University of London that explored the efficacy of the Company’s proprietary very low nicotine tobacco as a smoking cessation aid when combined with pharmacotherapy has been accepted for publication in Nicotine & Tobacco Research. The study was supported by a grant from the Global Research Awards for Nicotine Dependence (GRAND) funded by Pfizer, Inc.

The results of this study once again confirm the effectiveness of 22nd Century’s very low nicotine tobacco cigarettes as a smoking cessation aid. The Company’s very low nicotine cigarettes satisfy the behavioral aspect of smoking while delivering only trace amounts of nicotine. Indeed, it is 22nd Century’s fundamental assertion that very low nicotine cigarettes uncouple the behavioral/sensory aspects of smoking from the rapid delivery of nicotine.

The Queen Mary researchers noted: “[Very low nicotine cigarettes] have been shown to be satisfying... [and] were also shown to reduce tobacco withdrawal symptoms, including urges to smoke and low mood.” The clinical trial compared the combination of very low nicotine cigarettes together with two other treatments: 1) varenicline (Pfizer’s Chantix), and 2) nicotine replacement therapies (patches, lozenges, etc.). In each case, 22nd Century’s proprietary tobacco cigarettes provided smokers with a substantial boost in their efforts to stop smoking. Despite providing patients with only a 2-week supply of 22nd Century’s very low nicotine cigarettes (a separately published Phase II clinical trial used a 6 week treatment period) researchers found that participants who received very low nicotine cigarettes had higher quit rates at 1-week, 4-weeks, 6-weeks, and at the study’s maximum 12-weeks. However, due to the size of the study, researchers were unable to achieve statistically significant results at 6 and 12 weeks.

Although the study refers to 22nd Century’s cigarettes as “de-nicotinised cigarettes,” or DNCs, 22nd Century does not “de-nicotinise” or chemically strip tobacco to remove the nicotine. Instead, the Company’s proprietary very low nicotine tobacco, when grown and processed in the same manner as conventional tobacco, contains 95% less nicotine.

As the Queen Mary clinical trial was initiated in 2011, researchers used 22nd Century’s first generation very low nicotine tobacco. Accordingly, it is not surprising that these first generation cigarettes were not well suited to British consumer tastes. More recently, 22nd Century has developed very low nicotine tobacco blends designed according to consumer tastes in each of Europe, Asia, and the Americas that the Company believes will be very satisfying to smokers.

The Queen Mary trial highlights one of the important applications of 22nd Century’s proprietary very low nicotine tobacco. Another application of the novel technology is demonstrated by 22nd Century’s MAGIC 0 brand (0.04 mg nicotine yield; a 95% reduction in nicotine) which is the world’s only tobacco cigarette brand to provide smokers with the choice of a product which separates the rapid delivery of nicotine from the act of smoking. Sales of MAGIC 0 brand and MAGIC 2 brand have recently commenced in Europe and will be available in several additional countries by the end of 2015. 22nd Century does not represent that any of its current commercial brands are intended to be used as smoking cessation aids.

The Queen Mary study concludes: “The most pragmatic approach may be to offer an ongoing supply of [very low nicotine cigarettes] to those who want to continue using them.” This conclusion echoes Former US FDA Commissioner Dr. David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.” Indeed, 22nd Century is deeply committed to commercializing this approach and remains the only company in the world capable of producing virtually nicotine-free tobacco.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents and 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.