Nabi Biopharmaceuticals has announced nine-month data from its ongoing trial of NicVAX (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.
These nine-month data demonstrate NicVAX efficacy in supporting statistically significant and continuous abstinence rates by dose as well as by antibody response. The nine-month data also have enabled Nabi to determine what it believes is the most effective dose and schedule for NicVAX and determine the antibody concentration threshold for clinical efficacy. In May 2007, Nabi announced this trial's six-month data a statistically significant number of patients with a high anti-nicotine antibody response met the trial's primary endpoint of eight weeks of continuous abstinence between weeks 19-26.
"We are extremely pleased with the NicVAX data and the continued smoking cessation trends we've observed through nine months of this clinical trial," said Dr Leslie Hudson, Interim president and chief executive officer of Nabi. "Our latest analyses have helped us identify a NicVAX dose that achieves the high antibody levels associated with helping smokers successfully quit smoking and remain abstinent over long periods of time. These analyses have also provided us with data that are extremely important for our ongoing partnering efforts. We believe the full 12-month data will be invaluable as we determine next steps for our clinical development programme."
To gain greater perspective on these data, Nabi discussed its nine-month findings with nationally recognized smoking cessation researchers and the National Institute on Drug Abuse (NIDA). Nabi will use these validated and promising nine-month data to advance its partnership discussions surrounding NicVAX.
"The data seen to-date for NicVAX have been extremely encouraging," said Dr Dorothy Hatsukami, Forster Family Professor in Cancer Prevention and Professor of Psychiatry at the University of Minnesota Tobacco Use Research centre. "The data show that there is an observable link between the high antibody levels achieved with the 400 microgram NicVAX dosing regimen and the ability of these patients to quit smoking and to remain abstinent. This key development the success of a smoking cessation vaccine could have an important impact on how we address smoking and smoking relapse."