People, who have in the past, tried to quit smoking by various means but relapsed will be happier with the news about an anti smoking vaccine- NicVAX- that can hit the markets very soon. This anti smoking vaccine meant to help people quit smoking, has entered the III phase of clinical trials which, when successful, will clear the way of anti smoking injectable drug to enter the market, most probably next year.
How NicVAX Works?
NicVAX stimulates the immune system to produce antibodies that bind to nicotine in the bloodstream and makes the nicotine molecule too large to cross the blood-brain barrier and enter the brain. Once inside the brain, nicotine triggers the release of dopamine, a chemical linked to pleasure and to addiction. NicVAX ultimately prevents the pleasure that keeps people addicted to smoking and other nicotine use. During the clinical trials using the vaccine and placebo- carried out by nine different institutions including the University of California- it helped half of smokers to quit smoking. During the second phase of trials, participants were vaccinated six times and now 80 per cent gave up. Unlike nicotine replacement treatments, NicVAX does not enter the brain, and thus, does not have the same adverse psychological effects, like depression or suicidal ideation, associated with other treatments.
The vaccine that limits the ability of nicotine to enter the brain gives smokers a fighting chance to end the addiction as well as the relapse cycle. “Phase III trial of nicotine vaccine offers tremendous hope towards solving this immense public health problem,” said Dr. Francis Collins, Director, National Institutes of Health (NIH) that has granted $10 million from the American Recovery and Reinvestment Act to fund the phase III testing of NicVAX.
Nabi Biopharmaceuticals & GlaxoSmithKline Partnership
The maker of the anti-smoking vaccine NicVAX- Nabi Biopharmaceuticals- has entered a partnership with the pharma company GlaxoSmithKline Biologicals to develop the vaccine using Nabi’s intellectual property. GSK could elect to exercise its option to further develop and commercialize NicVAX as soon as the deal closes, which is expected to occur in the first quarter of 2010, or wait until the first Phase III results are available, which are anticipated in the second half of 2011. Successful completion of the phase III trials will bring the NicVAX vaccine closer to final FDA approval. Based on successful initial testing, the FDA has already granted NicVAX “fast track” designation for final testing and approval.