Xenova Group plc has initiated a second clinical trial for TA-NIC, its therapeutic vaccine which is under development for the treatment of nicotine addiction.

This second Phase I study builds upon the findings of a previous Phase I trial which were announced in June 2002. The results of this first study, which was the first evaluation of an anti-nicotine vaccine in man, showed that the vaccine generated a specific anti-nicotine response and that it was safe and well tolerated both systemically and locally. The objective of the new Phase I trial is to further establish safety and tolerability, and to determine the vaccination dose and schedule required to induce the optimal anti-nicotine antibody response. Three different doses of the vaccine will be evaluated. The impact of vaccination on nicotine-induced changes in heart rate and skin temperature will also be monitored.

Approximately 60 smokers will be recruited into a double-blind, randomised, placebo-controlled study which will be run at a European clinical centre experienced in testing smoking related therapies. Results of this study will be used to design a Phase II trial that will assess the effect of vaccination with TA-NIC on tobacco consumption. This Phase II trial is expected to begin during the second half of 2004.

Commenting on this new trial David Oxlade, CEO of Xenova Group plc said, "TA-NIC offers the hope of substantial benefit to smokers wishing to quit their habit. With this new trial we will be directly assessing the impact of antibodies on the physiological effects of nicotine. It represents an important step forward in strengthening the concept of vaccination as a treatment for nicotine addiction."