Does anyone know what the timeframe of the phase 2B trial? Thanks
This morning, 22nd Century Group, Inc. (OTCBB:XXII) announced progress towards commercialization of their prescription smoking cessation aid in development, X-22. The Company has filed an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the proprietary very low nicotine cigarettes and protocol as a stop smoking aid. Additionally, 22nd Century Group has requested that the FDA grant “Fast Track” designation to X-22. “Fast Track” is an expedited regulatory review of drugs undergoing clinical trials that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.
Through its exclusive technology, 22nd Century alters the level of nicotine (and other nicotinic alkaloids) in the tobacco plant to be decreased or increased through genetic engineering and breeding. In the case of X-22 cigarettes, the nicotine levels are roughly that of a common tomato (0.3 grams), representing 97% less nicotine than Marlboro® Gold (formerly Marlboro Lights®), the most commonly smoked brand in the U.S.
Immediately upon FDA clearance of the IND, 216 smokers will be enrolled in a multicenter Phase II-B clinical trial. The X-22 therapy protocol allows patients to smoke X-22 cigarettes without restriction over the 6-week treatment period to facilitate the goal of quitting by the end of 6 weeks. Primary endpoint results of the study – four weeks of continuous abstinence from smoking – are expected to be available this November. Quit rates of patients using X-22 cigarettes will be compared to those using an active control, cigarettes with conventional nicotine content.
Joseph Pandolfino, 22nd Century’s Chief Executive Officer, stated,
“There is clearly a large unmet medical need on a global scale for an effective, non-addictive, user-friendly smoking cessation product—without serious side effects. 22nd Century passionately believes X-22 is that product. The company is confident that the vast majority of smokers desiring to quit smoking would be willing to try X-22.”
Prior research through independent studies, including successful Phase II clinical trials, have demonstrated that VLN cigarettes made from 22nd Century’s proprietary tobacco facilitate quitting by satisfying smokers’ cravings for cigarettes while,
• greatly reducing nicotine exposure and nicotine dependence; and
• separating the act of smoking from the rapid delivery of nicotine.
An independent Phase II trial of considerable interest was conducted by Dr. Dorothy Hatsukami, Director of the National Transdisciplinary Tobacco Use Research Center at the University of Minnesota Masonic Comprehensive Cancer Center and one of the nine voting members of the 12-person Tobacco Products Scientific Advisory Committee (TPSAC) at FDA’s Center for Tobacco Products. The research compared the quitting efficacy of a VLN cigarette (containing 22nd Century’s VLN tobacco), an FDA-approved 4-mg nicotine lozenge, and a low nicotine cigarette (containing 30% of the nicotine of a typical cigarette) in a total of 167 patients treated for 6 weeks.
Point-prevalence abstinence at 6 weeks after the end of treatment was:
• 47% for the group using the VLN cigarette
• 37% for the nicotine lozenge group
• 23% for the low nicotine cigarette group (p=.0357)
Furthermore, the VLN cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. Unlike the low nicotine cigarette, the VLN cigarette was not associated with compensatory smoking behaviors. By the end of the 6-week treatment period, patients in the VLN group (whether they quit or not) on average were smoking 12 VLN cigarettes per day, compared to a baseline of 19 cigarettes per day of their usual brand. The protocol of 22nd Century’s upcoming Phase II-B clinical trial is similar to that of the University of Minnesota trial.
Mr. Pandolfino stated,
“Smokers have limited pharmacological choices for quitting: (i) nicotine in different forms, otherwise known as nicotine replacement therapy (NRT), (ii) Chantix® and (iii) Zyban®. Approximately 50% of U.S. smokers have already failed to quit with NRT and some users become addicted to NRT products. Both Chantix® and Zyban® were required by the FDA on July 1, 2009 to add boxed warnings to their package inserts.”
These warnings highlight that serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt and completed suicide, have been reported in patients taking Chantix® and Zyban®. (Chantix® is known as Champix® outside the U.S.)
According to the Centers for Disease Control and Prevention (CDC):
• Cigarette smoking is the leading cause of preventable morbidity and mortality in the United States.
• Approximately 440,000 premature deaths annually.
• Out of 46 million American smokers, approximately 20 million make a serious attempt to quit smoking every year.
• On average, it takes smokers 8 to 11 quit attempts before achieving long-term success.
• Less than 5% of smokers in the U.S. permanently quit smoking each year.
AI
