22nd Century Group Inc. announced that an update has been issued on the pivotal Phase III study entitled “Strategies for Reducing Nicotine Content in Cigarettes.”
Funded by the National Institutes of Health (NIH) and led by Eric Donny, Ph.D. of the University of Pittsburgh, this highly significant clinical trial will determine whether the harm caused by smoking is most effectively addressed by either 22nd Century’s proprietary Very Low Nicotine Content tobacco cigarettes (95% less nicotine than conventional cigarettes), or 22nd Century’s proprietary SPECTRUM tobacco cigarettes that contain progressively lower nicotine content.
The clinical trial update names 10 nationally recognized research centers, including the Mayo Clinic, the MD Anderson Cancer Center, Duke University, Johns Hopkins University, the Moffitt Cancer Center, and the University of California San Francisco. With an estimated enrollment of 1,250 patients, the on-going study is expected to be completed in March 2017. The Company expects the results of this study to accelerate the governmental approval process of the Company’s “X-22” smoking cessation product so that millions of lives and billions in healthcare costs can be saved each year.
“By evaluating 22nd Century’s Very Low Nicotine cigarettes against 22nd Century’s gradually reduced nicotine cigarettes, the Donny trial recognizes that reducing smokers’ exposure to nicotine is a vital public health goal. Contrary to false and misleading information recently disseminated by short-sellers of 22nd Century stock, we are confident that our patented technologies will produce multi-billion dollar products in both the tobacco and the pharmaceutical industries,” explained Henry Sicignano, III, president and CEO of 22nd Century Group. “Our Company is recognized by the National Institute of Health, the World Health Organization, and public health advocates around the world as absolutely key to reducing smokers’ exposure to nicotine; independent clinical studies continue to show that our Very Low Nicotine cigarettes have the potential to greatly impact public health.”