22nd Century Group, Inc. (OTCBB: XXII), a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22 Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.
X-22, a prescription smoking cessation aid in development, consists of a kit containing very low nicotine (VLN) cigarettes containing 22nd Century's proprietary tobacco. X-22 VLN cigarettes contain 97% less nicotine than Marlboro® Gold, the U.S. cigarette market leader, formerly known as Marlboro Lights®.
"Completed enrollment of our Phase II-B clinical trial for X-22 represents another key milestone for 22nd Century. We were originally targeting 216 subjects and are pleased to have 234 subjects in our study," explained Joseph Pandolfino, founder and CEO of 22nd Century.
22nd Century's Phase II-B trial is the largest study of its type to date. The X-22 therapy protocol allows subjects to exclusively smoke VLN cigarettes, without concurrent use of nicotine replacement therapy (NRT), over a 6-week treatment period to facilitate the goal of quitting by the end of treatment.
Primary endpoint results of the study, four weeks of continuous abstinence from smoking (measured immediately following the 6-week treatment period), will be announced by the company in early December 2011. Quit rates of subjects using X-22 cigarettes will be compared to quit rates of those subjects using active control cigarettes (containing conventional nicotine content). Two and three-month follow-up quit rates (from the end of treatment) will also be evaluated.
22nd Century submitted a request for Fast Track designation for X-22 and on August 18, 2011, the U.S. Food and Drug Administration (FDA) informed the company that designation of X-22 as a Fast Track product could not be granted at that time but, if the company desires further consideration, it should submit a new request for Fast Track designation. 22nd Century will file its subsequent Fast Track request with the FDA at approximately year-end 2011, which will include results of its Phase II-B clinical trial—the first clinical trial sponsored by 22nd Century under its own Investigational New Drug Application (IND). All previous smoking cessation studies with VLN cigarettes containing 22nd Century's proprietary tobacco, including Phase II clinical trials which all indicated efficacy, were independent studies and were not previously sponsored by 22nd Century under its own IND.
Mr. Pandolfino stated, "We believe X-22 will be granted Fast Track status by the FDA after completing our company-sponsored Phase II-B clinical trial because, as in other Phase II trials with VLN cigarettes, we expect X-22 to demonstrate one or more advantages (over currently approved smoking cessation products) in the following areas: efficacy, safety, compliance and convenience."