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.
