Nabi Biopharmaceuticals has completed enrolment in the first phase-III clinical trial of NicVAX (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse. The company initiated this clinical trial on November 3, 2009 and expects to have final data in the fourth quarter of 2011, now that enrolment is complete. A second phase-III trial began in March 2010 and enrolment is well under way with final data expected 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. 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). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency that confirms and supports the trial protocol.
Nabi closed an exclusive world-wide option and license agreement for the development and commercialization of NicVAX with GlaxoSmithKline Biologicals SA in March 2010, for a total potential consideration of over US$ 500 million, including a nonrefundable US$ 40 million upfront payment. In addition Nabi may also receive royalties on global sales of NicVAX and next-generation nicotine vaccines.
"We are very pleased that enrollment in this trial has been completed on schedule and enrolment in the second phase-III trial is progressing according to plan," said Dr Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "NicVAX has the potential to shift the smoking-cessation therapeutic paradigm from quitting to long-term abstinence. We have optimized 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 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."
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections.