Nabi and the National Institute on Drug Abuse Initiate Toxicity Studies of
Nabi(R) NicVAX(TM)
Monday, March 6, 2000 09:40 AM
Mail this article to a friend
BOCA RATON, Fla., March 6 /PRNewswire/ -- Nabi (Nasdaq: NABI, news, msgs) announced today
that it has initiated animal toxicity studies with Nabi(R) NicVAX(TM), a nicotine conjugate vaccine, in
conjunction with the National Institute on Drug Abuse (NIDA). If the results of these studies confirm the
safety of Nabi NicVAX, Nabi will use this information to support an Investigational New Drug (IND)
application to the FDA to allow clinical evaluation of the safety, and ultimately the efficacy, of Nabi
NicVAX in human clinical trials.
"The initiation of these animal toxicity studies is essential to the continued development of Nabi
NicVAX and we are pleased that NIDA has chosen to participate with us in these studies and sponsor
the ongoing animal testing," stated Dr. Robert Naso, Nabi Sr. Vice President. "Results of animal model
studies thus far have shown that Nabi NicVAX can induce high titers of nicotine-specific antibodies that
reduce nicotine levels in the brains of rats, attenuate the development of nicotine dependence, prevent
nicotine- induced blood pressure increases, and significantly reduce the hyperactivity induced in rats in
response to nicotine injections."
Nabi 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 conceptually receive
less positive feedback from his use of tobacco. If Nabi NicVAX is successful in clinical trials,
vaccination may prevent nicotine addiction in the new tobacco user. In the already addicted tobacco
user who is trying to quit, vaccination may help prevent relapse into addiction.
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.
quicken.webcrawler.com
Jack |
