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news.Nabi Biopharmaceuticals has completed patient recruitment in the second double-blinded, placebo-controlled Phase III clinical trial of NicVAX (Nicotine Conjugate Vaccine), the company's investigational candidate vaccine being developed to treat nicotine addiction and prevent smoking relapse.
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Nabi initiated this clinical trial in March 2010 and expects to have final data in early 2012.
The first clinical trial was initiated in November 2009 and completed enrollment in July 2010 with final data expected in the fourth quarter of 2011.
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.
However, 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.
The US Food and Drug Administration agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA).
Nabi closed an exclusive world-wide option and license agreement for the development and commercialization of NicVAX with GlaxoSmithKline Biologicals in March 2010, for a total potential consideration of over $500m, including a nonrefundable $40m upfront payment.
In addition Nabi may also receive royalties on global sales of NicVAX and next-generation nicotine vaccines.
Nabi president and CEO Raafat Fahim said that they are very pleased to complete enrollment of both of these trials on schedule.
"Both Phase III trials are on track to deliver final results by the dates we originally expected," Fahim said.
"We believe that we have taken all the steps needed to maximise the likelihood of success in Phase III including optimising the dose regimen, aligning the target quit date with peak antibody levels and defining the study design, trial protocol and end points through the SPA. If successful, NicVAX is on track to be the first-to-market nicotine vaccine for smoking cessation."