22nd Century Corrects Misinformation in News Article

In an October 27, 2009 press release, 22nd Century summarized some clinical trial results of using very low nicotine (VLN) cigarettes for smoking cessation, including one study led by Dr. Dorothy Hatsukami, Director of the Transdisciplinary Tobacco Use Research Center, University of Minnesota Cancer Center. The newspaper subsequently reported, “Findings from a University of Minnesota study on quitting smoking have turned up in a tobacco company’s press release before they were published, prompting an investigation by officials at the University’s Masonic Cancer Center.”

22nd Century has clarified that the results of Dr. Hatsukami’s clinical trial were already available from various public sources, four of which were emailed to the article’s author, Amy Durmaskin, by 22nd Century’s vice-president of R&D, Michael R. Moynihan, Ph.D., on the same day she contacted the company. None of those citations appeared. 22nd Century’s president, Joseph Pandolfino, reiterated, “All clinical trial data reported in our October 27th press release was already in the public domain and all aspects of our press release are 100 percent accurate.”

One of multiple public sources of the study’s results was from a presentation Dr. Hatsukami gave on February 6, 2008, entitled Science and Future Research Directions for Reduced Nicotine Content Cigarettes. This was online in November 2008 and can be found at: http://deainfo.nci.nih.gov/advisory/ncab/145_0208/presentations/Wednesday/900am_Hatsukami.ppt.

Quitting results of her smoking cessation trial were displayed on slide 23 and on slide 28, Dr. Hatsukami summarized, “Among smokers interested in quitting, denicotinized cigarettes: Reduced dependence, Facilitated abstinence, Reduced toxicant exposure, Did not change perceived risk for disease.”

Dr. Hatsukami concluded on slide 29, “Denicotinized cigarettes hold significant promise in helping smokers quit. Sensory aspects of smoking play a role in tobacco addiction. Larger, longer-term trial and follow-up is needed.” Mr. Pandolfino added, “The summary and conclusion of the study results in this presentation are more optimistic than what our company reported last week, yet it was asserted in the news article that we overstated the positive results.”

The very low nicotine (VLN) cigarettes, sometimes referred to as “nicotine-free” and “denicotinized,” used in this clinical trial contained 22nd Century’s proprietary tobacco. The company previously announced it is continuing development of a smoking cessation aid involving VLN cigarettes and has received guidance from the FDA for further trials.

Company website:

www.xxiicentury.com

22nd Century Limited, LLC
Joseph Pandolfino, 716-270-1523
President