Our Company is seeking a financial partner to fund the final Phase III clinical study on our X-22 smoking cessation product. X-22 is a kit containing very low nicotine (VLN) cigarettes going through the FDA-approval process as a prescription smoking cessation product. 22nd Century believes X-22 facilitates the quitting of smoking by satisfying smokers' cravings for cigarettes while (i) greatly reducing nicotine exposure and nicotine dependence and (ii) extinguishing the association between the act of smoking and the expected delivery of nicotine. The therapy protocol allows the patient to smoke VLN cigarettes over a six-week treatment period to facilitate the goal of the patient quitting smoking following the treatment period.
Numerous independent clinical studies have demonstrated that our Company's Very Low Nicotine (VLN) cigarettes increase quit rates whether VLN cigarettes were used alone or concurrently with nicotine replacement therapy (NRT), including the following clinical trials:
1. Phase II/III Clinical Study: Center for the Evaluation of Nicotine in Cigarettes (Eric C. Donny, Ph.D., et. al. – 2015 New England Journal of Medicine 373: 1340-1349)
• Participants who were assigned VLN cigarettes smoked one-third fewer cigarettes per day (14.9) than those assigned to their usual brand (22.2)
• Smokers of VLN cigarettes doubled their quit attempts versus smokers of conventional cigarettes
• Funded by the National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA)
2. Phase II Clinical Study: University of Minnesota Masonic Cancer Center Follow-up Study (Dorothy Hatsukami, Ph.D., et al. – 2013 Cancer Epidemiol Biomarkers Prev 22:1015-24)
• VLN cigarette had significantly better results than FDA-approved nicotine lozenge; even the smokers who ultimately didn't quit ended up reducing their cigarette consumption by one-third from 19 sticks per day to 12 sticks per day
3. Phase III Clinical Study: Clinical Trials Research Unit, University of Auckland (Natalie Walker, Ph.D., et al. – 2012, Addiction 107: 857–1867)
• VLN cigarette plus NRT (nicotine patch, gum and/or lozenge) significantly increased quit rates at all measured time points (3 & 6 weeks and 3 & 6 months) over use of NRT only
4. Phase II Clinical Study: University of Minnesota Masonic Cancer Center (Dorothy Hatsukami, Ph.D., et al. – 2010, Addiction 105:343-355)
• VLN cigarette had significantly better results than FDA-approved nicotine lozenge; even the smokers who ultimately did not quit ended up reducing their cigarette consumption by 37%
5. Phase II Clinical Study: Vector Tobacco (Karen Becker, Ph.D., et al. – 2008, Nicotine and Tobacco Research 10:1139-1148)
• The use of reduced nicotine cigarettes for 6 weeks, including VLN cigarettes for 2 weeks, before the use of the nicotine patch significantly increased quit rates over use of nicotine patch alone
6. Phase II Clinical Study: Roswell Park Cancer Institute (Hamed Rezaishiraz, M.D., Ph.D., et al. – 2007, Nicotine and Tobacco Research 11:1139-1146)
• Use of VLN cigarette before use of nicotine patch increased quit rates over use of reduced nicotine cigarette (containing 10 times more nicotine than the VLN) before nicotine patch
7. Phase II Clinical Study: Queen Mary University (Heyden McRobbie, MBChB., et al. – 2015, Nicotine and Tobacco Research 10:1093)
• Pfizer Inc. sponsored the study
• The group that used our VLN cigarettes had a 70% quit rate one week after stopping VLN cigarette use compared to a 53% quit rate of the group not using VLN cigarettes
Additional information is available on our Company website at www.xxiicentury.com.
We are flexible as to the terms and conditions of the joint venture, which we can discuss in detail with any qualified potential joint venture partners.