Nabi Biopharmaceuticals' NicVAX (Nicotine Conjugate Vaccine), the proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, has received Fast Track Designation from the US FDA.
"We believe this is the first Fast Track Designation for a smoking cessation product candidate, which is unprecedented, and provides further validation for our unique approach to addressing nicotine addiction," stated Henrik S. Rasmussen, senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals. "Smoking is the number one preventable cause of death in the western world, yet current smoking cessation therapies do not effectively treat the root cause of the addiction. We believe the vaccine approach inherent to NicVAX will provide clear patient advantages and a strong differentiation from currently marketed and development-stage products," he added.
Nabi Biopharmaceuticals has completed four Phase I/II studies, totalling close to 200 patients, for NicVAX. These studies demonstrated that NicVAX is well tolerated, highly immunogenic, produced dose-dependent increases in antibody titers, and showed a good indication of efficacy at the 200 ug dose with a 33 to 40 percent quit rate versus nine percent for smokers dosed with a placebo.
In September 2005, Nabi Biopharmaceuticals had received a $4.1 million grant by the US National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, for partial funding of the development program for NicVAX.
According to company release, Nabi Biopharmaceuticals will next conduct a Phase II "proof-of-concept" study for NicVAX, which is expected to commence during the second quarter of 2006. The study will be comprised of approximately 300 patients, a large enough sample size to establish both proof-of-concept and optimal dose identification for the company's Phase III program. The study results are anticipated in the second half of 2007.
Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists. Fast Track regulations are also designed to expedite the review process for designated products, including the potential for companies to ask for priority review.