X-22 IND clearance by FDA for 22nd Century’s Phase II-B Smoking Cessation Clinical Trial

22nd Century Group, Inc. (OTCBB: XXII) recently publicized that the US-FDA has cleared their X-22 (a prescription smoking cessation aid) Investigational New Drug (IND) application to carry out a Phase II-B clinical trial. 22nd Century is a company aimed at smoking cessation and developing reduced tobacco injury products.

22nd Century’s proprietary tobacco is used in the manufacture of X-22 that comprises a kit of very low nicotine (VLN) cigarettes. Compared to the US cigarette market leader Marlboro® Gold, previously known as Marlboro Lights®, 22nd Century’s X-22 cigarettes contained 97% less nicotine for the Phase II-B clinical trial. In an attempt to facilitate the objective of quitting smoking by the end of 6 weeks, patients were permitted to smoke X-22 cigarettes without restriction as per the X-22 therapy protocol over the 6-week treatment period.
Successful independent Phase II clinical trials, which were not sponsored by 22nd Century, have demonstrated that 22nd Century’s VLN cigarettes containing proprietary tobacco have satisfied smokers’ cigarette craving and facilitated quitting while (i) significantly decreasing nicotine exposure and nicotine dependence and (ii) unraveling the act of smoking from quick delivery of nicotine.
Smokers will be enrolled in a Phase II-B multicenter clinical trial in August. Results of four weeks of continuous abstinence from smoking, which is the primary outcome measure, are expected to be available in late November. The study will involve a comparison between quit rates of patients using X-22 cigarettes and active control cigarettes with conventional nicotine content. 22nd Century’s Vice President of Research and Development, Dr. Michael R. Moynihan, said “In addition to looking at the effect of X-22 cigarettes on initial quitting success, the study will also look at the effect on subjects’ attitude toward cigarettes and smoking behavior. Shorter-term independent studies with VLN cigarettes have shown reductions in craving for cigarettes even after quitting; we are very interested in looking at the persistence of the effect.”
22nd Century has been advised by the FDA that the agency’s decision of whether or not to grant “Fast Track” status to X-22 will be notified by September. Expedited regulatory review of drugs for clinical trials, which treat serious or life threatening diseases and exhibit the potential to cater to unmet medical needs, is provided by the Fast Track Development Program of the FDA.

The Centers for Disease Control and Prevention (CDC) demonstrated that in the United States, cigarette smoking causes nearly 440,000 annual premature deaths and is the foremost reason of preventable morbidity and mortality. Approximately 20 million out of the 46 million American smokers make a genuine attempt to quit smoking every year. Smokers make at least 8 to 11 quit attempts, on an average, before being successful. Each year in the US, not more than 5% of smokers quit smoking permanently. Nicotine replacement therapies (NRT), such as gums, patches, nasal sprays, inhalers, and lozenges, have been unsuccessful in approximately 50% of US smokers who have attempted to quit. On July 1, 2009, the FDA required two other FDA-approved smoking cessation products namely Chantix® known as Champix® outside the US and Zyban® to add Boxed Warnings to their package inserts.
“X-22 has the lowest nicotine content of any cigarette in the world and falls below the drastically reduced nicotine levels recommended by both Dr. David A. Kessler, former FDA Commissioner, and Professor Gregory N. Connolly of the Harvard School of Public Health,” explained 22nd Century’s founder and CEO, Joseph Pandolfino. He added, “X-22 cigarettes smoke, taste and smell like typical cigarettes and have the potential to significantly increase smoking cessation by encouraging more smokers to attempt quitting with an acceptable and familiar product.”

About 22nd Century Group, Inc.
22nd Century Limited, LLC (22nd Century) is a plant biotechnology company founded in 1998 whose proprietary technology is employed through genetic engineering and breeding to either decrease or increase levels of nicotine or other nicotinic alkaloids in the tobacco plants.

A total if 98 issued patents in 79 countries (inhabiting at least 75% of the world’s smokers) are owned or exclusively controlled by the company. 22nd Century is committed to the development and commercialization of (i) the most effective and acceptable smoking cessation products worldwide and (ii) consumer-acceptable modified risk tobacco products that reduce exposure to smoke toxins, as compared to conventional cigarettes for those smokers who refuse to quit smoking. 22nd Century became a wholly-owned subsidiary of 22nd Century Group, Inc. through a merger on January 25, 2011. The company publicized on June 22, 2011 that an IND was submitted to the FDA requesting a “Fast Track” designation to X-22.

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

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