Nabi Biopharma Concludes Patient Recruitment In NicVAX Phase III Study

NicVAX is Nabi’s proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

Nabi said that the patient enrollment in a second Phase III trial which it has initiated in March 2010 is under way and the company is expecting the data in early 2012.

Both Phase III studies for NicVAX are double-blinded, placebo-controlled studies enrolling approximately 1,000 patients each.

The primary endpoint of each study is long-term abstinence from smoking at 12 months. Abstinence will be evaluated by several measures, including self-reported cigarette consumption and exhaled carbon monoxide.

Whereas, the secondary endpoints include the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency.

Raafat Fahim, president and CEO of Nabi Biopharma, said: “We are very pleased that enrollment in this trial has been completed on schedule and enrollment in the second Phase III trial is progressing according to plan.

“NicVAX has the potential to shift the smoking-cessation therapeutic paradigm from quitting to long-term abstinence. We have optimised the dose regimen, aligned the target quit date with peak antibody levels and have defined the study design, trial protocol and end points through the Special Protocol Assessment (SPA).

“We believe that we have undertaken all the necessary steps to maximize the likelihood of success in Phase III. NicVAX is on track to be the first-in-class nicotine vaccine for smoking cessation. No other competitors have reached this stage of development.”