Nabi reports final smoking vaccine data

The USA's Nabi Biopharmaceuticals reported positive final results from its Phase II NicVAX (nicotine conjugate vaccine) schedule optimization immunogenicity study to assess the antibody response and safety of a 400mcg, six-dose immunization schedule.

The firm says the final results from the study confirm that significantly-higher anti-nicotine antibody levels can be generated three months earlier and in a much higher percentage of subjects for sustained periods of time than observed in previous NicVAX studies. Antibody levels achieved at 14 weeks were more than two-fold higher than those at the same time point in the Phase IIb proof-of-concept study as a result of the added injection. Moreover, over 80% of subjects who completed the six-dose 400ug NicVAX regimen had anti-nicotine antibody levels above the target threshold at the planned week 14 "quit date." The revised schedule, after all six doses were administered, continued to be well tolerated with an adverse event profile comparable to previous NicVAX clinical studies.

NicVAX is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. The drug is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. The firm claims that preclinical and previous clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes NicVAX also could be effective in preventing smoking relapse.