Nabi Biopharmaceuticals, specializing in using the immune system to develop products that counteract nicotine addiction and gram-positive bacterial infections, announced today that it has completed enrollment in the second Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine). NicVAX is Nabi’s proprietary candidate vaccine for treating nicotine addiction. Enrollment for the first clinical trial was completed in July.
NicVAX works by getting the immune system to produce antibodies that block nicotine from reaching receptors in the brain, receptors that release dopamine and other stimulants. When fewer such stimulants are released, the pleasurable and addictive effects of nicotine are diminished, making it easier to quit smoking. In addition, since the antibodies circulate for long periods of time, Nabi believes that NicVAX may also prevent smoking relapse and support long-term abstinence.
Both Phase III studies for NicVAX are double-blinded, placebo-controlled studies, involving approximately 1,000 patients each. The primary endpoint of each study is long-term abstinence from smoking at 12 months. The U.S. Food and Drug Administration agreed with Nabi on the design of the study, its protocol and end points, through a Special Protocol Assessment (SPA). The SPA forms a foundation to support approval of a New Drug Application.
Nabi President and CEO, Dr. Raafat Fahim, commented on the importance of the enrollment. “We 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. We believe that we have taken all the steps needed to maximize the likelihood of success in Phase III including optimizing 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.”
In March, the company closed an exclusive world-wide option and license agreement for the development and commercialization of NicVAX with GlaxoSmithKline Biologicals SA for a total potential consideration of over $500 million, including a nonrefundable $40 million upfront payment. Nabi may also receive royalties on global sales of NicVAX and next-generation nicotine vaccines. Additional good news came in the form of a recent $244,479 grant for the development of NicVAX from the Internal Revenue Service, through the Therapeutic Discovery Project Credit Program.
For additional information about Nabi Biopharmaceuticals, please visit www.nabi.com
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