WILLIAMSVILLE, N.Y. -- (BUSINESS WIRE) --

22nd Century Group, Inc. (OTCBB: XXII), a company focused on smoking cessation and tobacco harm reduction products, today announced that its wholly-owned subsidiary, 22nd Century Limited, LLC, enrolled the first patients in its Phase II-B clinical trial for X-22, a prescription smoking cessation aid in development.

X-22 consists of a kit of very low nicotine (VLN) cigarettes made from 22nd Century's proprietary tobacco. X-22 cigarettes contain 97% less nicotine than Marlboro^® Gold, the U.S. cigarette market leader, formerly known as Marlboro Lights^®. In the Phase II-B protocol, subjects are assigned to smoke X-22 (or active control cigarettes) during a 6-week treatment period to facilitate the goal of quitting by the end of 6 weeks.

More than 200 smokers will be enrolled in the multicenter Phase II-B clinical trial by the end of August 2011. Primary endpoint results of the study, four weeks of continuous abstinence from smoking, are expected to be available in late November 2011. Quit rates of patients using X-22 cigarettes will be compared to quit rates of those using active control cigarettes with conventional nicotine content. Two and three-month follow-up quit rates (from the end of treatment) will also be evaluated.

The FDA has advised 22nd Century that the Agency will decide by September 2011 whether to grant "Fast Track" designation to X-22. The FDA's Fast Track Development Program is designed to facilitate development and expedites the review of drugs undergoing clinical trials that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.

According to the Centers for Disease Control and Prevention (CDC), cigarette smoking is the leading cause of preventable morbidity and mortality in the United States, causing approximately 440,000 premature deaths annually. Out of 46 million American smokers, approximately 20 million make a serious attempt to quit smoking every year. On average, it takes smokers 8 to 11 quit attempts before achieving long-term success. Less than 5% of smokers in the U.S. permanently quit smoking each year. Approximately 50% of U.S. smokers have failed to quit using nicotine replacement therapy (NRT): gums, patches, nasal sprays, inhalers and lozenges. The other two FDA-approved smoking cessation products, Chantix^® (known as Champix^® outside the U.S.) and Zyban® were required by the FDA on July 1, 2009 to add Boxed Warnings to their package inserts.

About 22nd Century Group, Inc.

Founded in 1998, 22nd Century Limited, LLC (22nd Century) is a plant biotechnology company whose proprietary technology allows for the level of nicotine (and other nicotinic alkaloids) in the tobacco plant to be decreased or increased through genetic engineering and breeding. The company owns or exclusively controls 98 issued patents in 79 countries where at least 75% of the world's smokers reside. 22nd Century is committed to developing and commercializing (i) the world's most effective and acceptable smoking cessation aid and (ii) for those smokers who refuse to quit smoking, consumer-acceptable modified risk tobacco products that reduce exposure to smoke toxins, as compared to conventional cigarettes. Through a merger on January 25, 2011, 22nd Century became a wholly-owned subsidiary of 22nd Century Group, Inc. On July 21, 2011, the company announced that the FDA cleared the X-22 IND for the Phase II-B clinical trial.

For additional information, please visit: www.xxiicentury.com

Safe-Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release may contain forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the company, its directors or its officers with respect to the contents of this press release. The words "may," "would," "will," "expect," "estimate," "anticipate," "believe," "intend" and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the company's ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors including the "Risk Factors" disclosed in the company's reports filed with the SEC under the Exchange Act, including the company's Form S-1/A filed with the SEC on August 8, 2011 and potential uncertainties regarding the timing of enrollment and results of the X-22 Phase II-B clinical trial and FDA-designation of X-22 for Fast Track status.

CONTACT:

22nd Century Desk
Redington, Inc.
Tom Redington
203-222-7399