A new study showed a glimmer of hope for a troubled nicotine vaccine after a series of clinical trial setbacks. Investigators hold out hope for new weapons against smoking, a leading cause of deadly cancers, lethal lung disease and other fatal ailments, yet evidence from the latest study could be too scant to win over some skeptics.
The NicVAX candidate has a checkered history of success in clinical trials, yet the latest study reported online in the American Journal of Psychiatry Feb. 22 provided promising evidence that the vaccine could have a place in helping smokers kick their habits. The study showed a 12.5% drop in nicotine binding to a key brain receptor and a 23.6% decrease in nicotine entering the brain after vaccinations, Medscape reported. But the study observed just 11 patients, way fewer than the recent mid- and late-stage trials of the vaccine that ended in failure.
If anything, the study demonstrated that NicVAX, which triggers an immune response to keep nicotine from reaching pleasure centers in the brain, stymies entry of nicotine into the brain. Yet the problem has always been showing that the vaccine can work across larger pools of patients in improving smoking cessation. It failed to beat placebo in Phase III development in 2011 and last year fell short in improving treatment with Pfizer's ($PFE) antismoking pill Chantix.
After the series of failures, the developer of the vaccine, Nabi, combined in November 2012 with another group to form Biota Pharmaceuticals. On Biota's website, the company lists clinical development of NicVAX as "on hold." And Biota appears to be focusing on anti-infective drugs, with two active midstage development programs for laninamivir octanoate and vapendavir.
Health advocates haven't given up on nicotine vaccines, even if Biota has NicVAX--which Nabi had developed in partnership with GlaxoSmithKline ($GSK)--on ice. The NIH has supported the development of venture-backed Selecta Biosciences' synthetic nicotine vaccine, which is in early-stage development. We'll see whether this program can succeed where others such as NicVAX failed.