BOCA RATON, Fla., Dec. 17 /PRNewswire/ -- Nabi® (Nasdaq: NABI - news) announced the publication of results from preclinical studies on Nabi-NicVAX(TM) in the Dec. 17, 1999, issue of the journal ``Pharmacology, Biochemistry, and Behavior.'' The data in the article entitled, ``A Nicotine Conjugate Vaccine Reduces Nicotine Distribution to Brain and Attenuates Nicotine Behavioral and Cardiovascular Effects in Rats,'' was generated by research teams led by Paul Pentel, Ph.D., Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minneapolis, Minnesota; David Malin, Ph.D. at the University of Houston-Clear Lake, Texas; and Ali Fattom, Ph.D., at Nabi in Rockville, MD. The published results demonstrate that NicVAX-induced antibodies can reduce or prevent some of the pharmacokinetic, cardiovascular, and behavioral consequences of nicotine injections in rats.
The studies showed that antibodies to NicVAX were able to attenuate the hyperactivity induced in rats in response to nicotine injections. Antibodies to NicVAX were also able to prevent nicotine-induced blood pressure increases compared to controls. Comparisons of the amount of nicotine in the brains of animals injected with levels of nicotine equivalent to two cigarettes, revealed that animals that received the nicotine antibodies had 64% less nicotine in their brains compared to control animals. Moreover, interference with nicotine reaching the brain persisted in immunized animals that were given nicotine five times within an 80-minute period; this is equivalent to nicotine from ten cigarettes. The effects observed at nicotine doses and blood concentrations equaling or exceeding those typically associated with nicotine exposure in cigarette smokers suggest a promising role for NicVAX in the treatment or prevention of nicotine addiction in humans.
It is well established that nicotine quickly enters into the blood stream and crosses into the brain upon the use of tobacco. When nicotine enters into the brain, it binds to receptors that cause the release of neurotransmitters that, in turn, are responsible for the pleasurable sensation that occurs from tobacco use. These effects are believed to lead to nicotine addiction. Nabi- NicVAX is an experimental, proprietary, conjugate vaccine comprised of nicotine molecules attached to a nontoxic recombinant carrier protein. Vaccination with NicVAX has been shown to generate high titers of nicotine- specific antibodies in experimental animals. NicVAX has been designed to induce antibodies to nicotine that can bind to nicotine in the bloodstream. Antibody/nicotine complexes are too large to cross the blood brain barrier and as a result the nicotine is held in the blood until it is metabolized. Since the nicotine cannot reach the brain, it cannot stimulate the release of neurotransmitters and the tobacco user should receive less positive feedback from his use of tobacco. Thus in the new tobacco user, vaccination may prevent nicotine addiction. In the already addicted tobacco user who is trying to quit, vaccination may help prevent relapse into addiction.
``The results obtained thus far with Nabi-NicVAX in these animal models is very exciting,'' declared Dr. Robert Naso, Senior Vice President. ``If similar effects can be achieved in humans in clinical trials, we may be able to use the vaccine to prevent nicotine addiction or to help addicted tobacco users kick their nicotine habits.''
Tobacco use is the single leading preventable cause of death in the United States. It is estimated that more than 50 million Americans are current smokers and another 6.8 million use smokeless tobacco. In the U.S., there are approximately 6 million teenagers who reportedly use tobacco regularly, and it is estimated that more than 100,000 adolescents under 13 years of age smoke cigarettes. On a worldwide basis one out of three men and women over age 18 smokes. Economically, smoking is reportedly responsible for approximately 7 percent of total U.S. health care costs -- estimated at $50 billion each year.
Nabi provided funding for the scientific research. Dr. Paul Pentel and his colleagues at Hennepin County Medical Center, Minneapolis, Minnesota, were also partially funded by the National Institute on Drug Abuse (NIDA), National Institutes of Health, under grant DA10714 (PRP).
Nabi, a fully integrated biopharmaceutical company, has a broad product portfolio and significant R&D capabilities focused on the development and commercialization of drugs that prevent and treat infectious and autoimmune diseases. Nabi currently has several clinical trials underway in these areas and has four marketed pharmaceutical products. Additional information may be obtained on the Company's website at: www.nabi.com.
This press release may contain forward-looking statements that reflect the Company's current expectations regarding future events. While these statements reflect the Company's best current judgment, they are subject to risks and uncertainties. Actual results may differ significantly from the results projected herein due to a number of factors, including, but not limited to, the impact on the Company of current industry supply and demand factors and the supply of and demand for the Company's individual products; margin pressure on the Company's non-specific antibody product line; future sales growth prospects for its pharmaceutical products; the likelihood that any product in the research pipeline can receive regulatory approval in the U.S. or abroad or be successfully developed, manufactured and marketed; failure to receive licensure for the Boca Raton manufacturing facility; and dependence upon third parties to manufacture product. These factors are more fully discussed in the Company's most recent Form 10-K filed with the Securities and Exchange Commission.
SOURCE: Nabi
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