Xenova Group’s TA-NIC for the Treatment of Nicotine Addiction
July 14, 2004 by admin · Leave a Comment
On July 14, 2004 Xenova Group plc released results of a second clinical trial with TA-NIC, a therapeutic vaccine under development for the treatment of nicotine addiction. The company reported that this randomized, placebo controlled, double-blinded study involved a total of 60 smokers and was designed to prove safety and tolerability data while measuring anti-nicotine antibody response in participants. The company reported no serious adverse events and indicated that anti-nicotine antibody levels were dose dependent. Although not an efficacy trial, 43% of smokers receiving TA-NIC either gave up smoking or reported a decrease in smoking related pleasure compared to 9% in the placebo group.
Nicotine by itself does not induce an antibody or immune response. However, when conjugated with an immunogenic protein such as recombinant cholera protein, an immune response is generated. These anti-nicotine antibodies may bind to the nicotine in a smoker’s blood and decrease or reduce the positive effects that nicotine creates in the smoker. In the Phase I trial, TA-NIC was delivered by 5 vaccinations over 8-20 weeks with a booster given 9 months after the first injection.
According to the 2001 National Health Interview Survey, approximately 22.8% of American adults (46.2 million) are currently smokers. Smoking rates in the United States have been declining since 1965.
The Biohorizon Emerging Health Technology Database contains two other emerging technologies for the treatment of Nicotine Addiction/Smoking Cessation, NicVax and Acomplia™. Notably, Nabi Pharmaceutical’s NicVax is another Phase I therapeutic vaccine, while Sanofi’s Acomplia™ is a Phase III drug therapy under development for both obesity and smoking cessation.
TA-NIC is an early stage therapeutic vaccine for smoking cessation with interesting Phase I trial results and substantial obstacles in the form of pivotal Phase 3 trials to overcome. We currently recommend no assessment activities for health services clients at this time.
Technology Details
Target Disease / Indication: Smoking Cessation/Nicotine Addiction
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Addictions
Regulatory Status: Phase I
BioHorizon Impact Score: 53/100 – Moderate
