Xenova Reports Anti-Smoking Vaccine Preliminary 12-Month Trial Results

Xenova Group has announced preliminary 12-month findings from the second Phase I trial of TA-NIC, the company's therapeutic vaccine being developed for the treatment of nicotine addiction.

A total of 60 subjects who smoked between 10 and 75 cigarettes a day were recruited into the trial, divided into three cohorts. Within each cohort of 20 smokers, 16 received the active vaccine and four received the placebo.

The primary objectives of the study were to evaluate the safety, tolerability and immunogenicity versus placebo of three doses of TA-NIC -- 50 ug, 250 ug and 1000 ug. The vaccine was administered by intramuscular injection at weeks zero, two, four, six, eight and 12 with a booster at 32 weeks. Secondary objectives included recording the number of cigarettes smoked per day, determining the time to first cigarette and the time to relapse following a quit attempt at Week 12 and if necessary another quit attempt at Week 32. These quit rates were then assessed again after 12 months.

Initial 20-week immunogenicity data and other findings were reported in July 2004.