Successful results from second TA-NIC trial
Xenova Group has announced initial results from the second clinical trial of TA-NIC, the company's therapeutic vaccine being developed for the treatment of nicotine addiction.
Xenova Group has announced initial results from the second clinical trial of TA-NIC, the company's therapeutic vaccine being developed for the treatment of nicotine addiction.
60 smokers, divided into three cohorts of 20 subjects, have been recruited into this double-blind, randomised, placebo-controlled study. The objectives of this second Phase I clinical study were to explore the safety, tolerability and level of anti-nicotine antibody response to increasing doses of the vaccine TA-NIC, and to select a dose for Phase II/III evaluation.
Key findings from the study were:
• no drug-related serious adverse events were seen in any cohort
• minimal injection-site effects were seen at the dose selected for Phase II/III studies
• anti-nicotine antibody responses were dose dependent
The selected dose showed an improved anti-nicotine antibody response profile compared with the lowest dose tested:
• approximately twice the level of anti-nicotine antibodies were observed
• faster and more rapid onset of anti-nicotine antibody response was achieved
Although not designed to test the effect of the TA-NIC vaccine on smoker's quit rates, there was a clear reduction across all groups receiving TA-NIC compared with those with the placebo group, in terms of those smokers who voluntarily quit during the 12-week period or self-reported a reduction in smoking pleasure
At week six, 19 out of the 44 (43%) subjects receiving TA-NIC voluntarily gave up smoking or reported reduced pleasure when smoking compared with only 1 out of 11 (9%) receiving the placebo
On the basis of these results, a Phase II/III dose has been selected for further clinical evaluation. The final data from this Phase I study is expected at the end of this year (2004) with Phase II trials commencing shortly thereafter.
David Oxlade, ceo of Xenova said: 'We are most encouraged by these results. The next stage of trials will test TA-NIC's ability to help smokers break the habit and thereby reduce the serious consequences to health caused by smoking.'