$XXII Files Investigational New Drug Application and Fast Track Request for X-22; Phase II-B Clinical Trial to Commence Immediately Upon FDA Clearance -

22nd Century Files Investigational New Drug Application and Fast Track Request for X-22; Phase II-B Clinical Trial to Commence Immediately Upon FDA Clearance - MarketWatch:

"WILLIAMSVILLE, N.Y., Jun 22, 2011 (BUSINESS WIRE) -- 22nd Century Group, Inc. XXII 0.00% , a company focused on smoking cessation and tobacco harm reduction, announced today that 22nd Century Limited, LLC submitted an Investigational New Drug Application (IND) to the U.S. Food & Drug Administration (FDA) 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 for 22nd Century's Phase II-B clinical trial contain 97% less nicotine than Marlboro(R) Gold, the U.S. cigarette market leader, formally known as Marlboro Lights(R). The X-22 therapy protocol allows patients to smoke X-22 cigarettes without restriction over the 6-week treatment period to facilitate the goal of quitting by the end of 6 weeks.
Immediately upon FDA clearance of the IND, 216 smokers will be enrolled in a multicenter Phase II-B clinical trial. Primary endpoint results of the study, four weeks of continuous abstinence from smoking, are expected to be available this November. Quit rates of patients using X-22 cigarettes will be compared to those using an active control, cigarettes with conventional nicotine content"