Replies to post #263 on 22nd Century Group Inc (XXII)

[timorr]

22nd Century Sponsored Clinical Trial

22nd Century sponsored a Phase II-B clinical trial (238 subjects) under its own investigational new drug application cleared by the U.S. Food and Drug Administration (FDA) in July 2011. The X-22 VLN cigarettes utilized in the company’s trial had a nicotine content of less than half of the nicotine content of the VLN cigarettes utilized in the above six summarized clinical trials. Although there was no statistically significant difference in quit rates compared to the active control (a cigarette containing conventional nicotine levels), there was a significant reduction in smoking during the 6-week treatment period and post treatment from baseline. 22nd Century and independent researchers believe that the nicotine content of X-22 utilized in the company’s Phase II-B trial was below a cessation effective threshold. As was the case with independent clinical trials utilizing VLN cigarettes, there were no serious adverse events attributable to X-22 and the product was well tolerated. Going forward all company-sponsored clinical trials will utilize VLN cigarettes with a relatively higher nicotine content.

Clinical Pathway to FDA Approval

22nd Century has licensed Hercules Pharmaceuticals LLC, its pharmaceutical subsidiary, exclusive worldwide rights to X-22. Hercules Pharmaceuticals will evaluate results and data from recently completed independent clinical trials that utilized the company’s VLN cigarette with a slightly higher nicotine content to determine which variables optimize quitting. Upon completing analyses of these trials, the company expects to conduct Phase III clinical trials. Hercules Pharmaceuticals is currently identifying potential partners for the further development and worldwide commercialization of X-22.

[timorr]

Don't hesitate to call the company directly. They are better than any company I've ever seen at responding. He called me twice when I wasn't available and still hung in with me. Just to show how old and out dated I am , it took me two days before I thought to leave him my cell #. All my kids don't even own home phones anymore. Anyway Henry is very open and straight forward.

[timorr]

A separate and independent smoking cessation Phase II trial that utilized VLN cigarettes that 22nd Century supplied (containing approximately 95% less nicotine as compared to conventional cigarettes) has recently concluded, and the results are expected to be available in 2012. Over a 6-week treatment period, this 3-arm study evaluated smokers using just VLN cigarettes, just the 21-mg patch and both products concurrently. The results of this Phase II trial will be compared to 22nd Century's Phase II-B trial to determine the variables that optimize cessation, including nicotine content. 22nd Century's management is confident that its VLN cigarettes are a useful tool for smoking cessation and that the results of its Phase II-B trial will be crucial in determining the optimal nicotine content of the company's VLN cigarettes for cessation going forward.

Another independent smoking cessation trial utilizing VLN cigarettes recently concluded, however, subjects in this Phase III trial did not just use VLN cigarettes. Dr. Michael Moynihan, 22nd Century's Vice President of Research and Development, noted, "The New Zealand Heraldreported last week that a 'groundbreaking' study by Auckland University found that smokers offered VLN cigarettes in conjunction with nicotine replacement therapy (NRT) had a higher quit rate than those given just NRT patches, gums or lozenges."

The reduction in cigarette usage in 22nd Century's own Phase II-B clinical trial and in other independent studies suggests a significant opportunity for 22nd Century's VLN cigarettes to potentially obtain a "modified risk" claim under the Tobacco Control Act. The company expects the final regulations for modified risk tobacco products to be issued April 2012 by the U.S. Food and Drug Administration