22nd Century initiates enrollment in Phase II-B clinical trial of X-22 for smoking cessation

Aug 8 2011

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.