Celtic granted US IND for nicotine vaccine

Celtic Pharmaceutical Holdings, a Bermuda-based global private equity investment firm focused on the biotechnology and pharmaceutical industries, has received US Investigational New Drug approval for TA-NIC, a vaccine for the treatment of nicotine addiction.

The product is designed to induce nicotine-specific antibodies. When nicotine enters the bloodstream of a TA-NIC-dosed patient it will encounter and bind to these antibodies. The resulting complex is too large to cross the blood-brain barrier, so the pleasurable stimulus which typically accompanies smoking should be absent or reduced, the firm noted.

According to the firm, the prior owner of TA-NIC completed two Phase I/II UK studies in 120 smokers, which did not find any unexpected adverse events and showed indications of efficacy compared to placebo. These studies are the basis for a large randomized Phase IIb trial, which will be conducted in the USA under the IND. This placebo-controlled study, designed to assess the efficacy and safety of TA-NIC in managing smoking cessation when given in conjunction with current standard support treatments is scheduled to begin in the coming weeks. The double-blind, multicenter dose-ranging trial is enrolling up to 200 patients in each of three treatment arms. The primary endpoint of the study is the abstinence rate at six months.