Nabi Biopharmaceuticals Initiates Second Phase III Study for NicVAX as an Aid to Smoking Cessation and Long-term Abstinence
- Category: Vaccines
- Published on Wednesday, 17 March 2010 02:00
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Nabi Biopharmaceuticals announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX(R) (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse
ROCKVILLE, MD, USA | March 17, 2010 | Nabi Biopharmaceuticals (Nasdaq:NABI) announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX(R) (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has 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 (EMEA) that confirms and supports the trial protocol.
"With the initiation of this study, we are now fully engaged in the pivotal clinical program that we believe will lead to the successful licensure of NicVAX," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "NicVAX has the potential to address one of the most significant unmet medical needs in the world today. We aim to fully realize the benefits of NicVAX for our shareholders and for people who wish to quit smoking and remain quit."
How NicVAX Works
When nicotine enters the bloodstream, it quickly crosses the blood-brain barrier and binds to nicotinic receptors in the brain, triggering the release of stimulants like dopamine that provide the smoker with a positive sensation that eventually leads to addiction. NicVAX stimulates the immune system to produce antibodies that bind to nicotine creating an antigen/antibody complex that is too large to cross the blood-brain barrier. In this way, NicVAX blocks nicotine from reaching these receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. Pre-clinical and previous clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the nicotine antibodies circulate for long periods of time, Nabi believes NicVAX may also be effective in preventing smoking relapse. This is a very important difference between NicVAX and existing anti-smoking treatment therapies. Relapse is a significant challenge facing smokers and, with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.
About the Phase III Study
Similar to the initial Phase III study for NicVAX, this study is a double-blinded, placebo-controlled study comprised of approximately 1,000 patients. The primary endpoint of the study is the abstinence rate at 12 months. Abstinence will be evaluated by several measures, including self-reported cigarette consumption, and exhaled carbon dioxide. 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. Study results are anticipated by early 2012.
About Nabi Biopharmaceuticals
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. Nabi Biopharmaceuticals is currently developing NicVAX(R) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit www.nabi.com.
SOURCE: Nabi Biopharmaceuticals