"NicVAX is an entirely new approach to fighting and preventing nicotine addiction," said David J. Gury, Nabi Biopharmaceuticals chairman, president and chief executive officer.
Of the 48 million adult U.S. smokers, about 70 percent, or nearly 34 million people have made at least one attempt to stop, yet only 1.2 million quit permanently, according to the U.S. Centers for Disease Control and Prevention.
"The reason quitting smoking is so difficult is because nicotine is highly addictive," according to Robert Naso, Ph.D., Nabi Biopharmaceuticals senior vice president of quality, regulatory and product development. "When a person smokes, nicotine enters the body and goes straight to the brain, where it generates positive sensations, such as pleasure and relaxation. However, the body does not develop antibodies against nicotine, no matter how much or for how long a person smokes. Based on earlier animal studies, NicVAX is a technology that enables the body to develop antibodies to nicotine. We believe that these antibodies, acting much like a sponge, will soak up the nicotine, preventing it from reaching the brain."
"By reducing the amount of nicotine available to stimulate the brain's pleasure centers, an immunized tobacco user would theoretically receive no positive reinforcement from nicotine use," according to Dr. Naso. In pre-clinical animal studies NicVAX generated antibodies that reduced nicotine levels in the brain by up to 64 percent and blocked the effects of nicotine even at relatively high doses.
The phase I clinical trial will examine NicVAX's safety and ability to stimulate the immune system in nonsmokers. During the trial, investigators will randomly assign 20 healthy, nonsmoker adults to receive either NicVAX or a placebo injection. Safety and antibody levels against nicotine will be measured during the study. Neither the investigator nor the subject will know what was injected until the study ends.
Nabi Biopharmaceuticals has planned additional, phase II clinical trials to investigate NicVAX's safety and ability to stimulate immunity in smokers and ex-smokers. If the investigational vaccine performs well in these trials, the company will pursue definitive, phase III trials to evaluate the vaccine's efficacy to treat nicotine addiction and prevent it in people who have not yet started smoking.
At least 1.1 billion people worldwide, a third of the global adult population, use tobacco products which cause 4 million premature deaths annually, according to the World Health Organization. In the United States, tobacco use is the single leading preventable cause of death, causing more than 430,000 deaths each year and tallying an estimated $50 billion in direct medical and $47 billion in indirect non-medical costs.
Development of NicVAX is funded, in part, by grant DA13327 from the National Institute on Drug Abuse.
About Nabi Biopharmaceuticals Nabi Biopharmaceuticals discovers, develops, manufactures and markets products that power the immune system to help people with serious, unmet medical needs. The company has a broad product portfolio and significant research capabilities focused on developing and commercializing novel vaccines and antibody-based therapies that prevent and treat infectious, autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, ITP, and nicotine addiction. Nabi Biopharmaceuticals has several products in clinical trials, as well as four marketed products, including Nabi-HB™ [Hepatitis B Immune Globulin (Human)], for the prevention of hepatitis B infections and WinRho SDF (r), [Rho (D) Immune Globulin Intravenous (Human)], for the treatment of acute, chronic and HIV-related immune thrombocytopenia purpura. The company is headquartered in Boca Raton, Florida, with principal R&D offices and laboratories in Rockville, Maryland. Additional information about Nabi Biopharmaceuticals may be obtained on the company's website at www.nabi.com.
This press release contains 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 costs of research and development; dependence Rockville, Maryland, June 12, 2002 – Nabi Biopharmaceuticals (Nasdaq: NABI) announced today that they have initiated NicVAX™ (Nicotine Conjugate Vaccine) phase I testing in humans. NicVAX is a proprietary and novel investigational vaccine designed to help the body develop antibodies that bind to nicotine and block it from reaching the brain. If shown to be safe and effective in subsequent clinical trials, NicVAX may help millions of people worldwide kick their addiction to cigarettes and tobacco products.
"NicVAX is an entirely new approach to fighting and preventing nicotine addiction," said David J. Gury, Nabi Biopharmaceuticals chairman, president and chief executive officer.
Of the 48 million adult U.S. smokers, about 70 percent, or nearly 34 million people have made at least one attempt to stop, yet only 1.2 million quit permanently, according to the U.S. Centers for Disease Control and Prevention.
"The reason quitting smoking is so difficult is because nicotine is highly addictive," according to Robert Naso, Ph.D., Nabi Biopharmaceuticals senior vice president of quality, regulatory and product development. "When a person smokes, nicotine enters the body and goes straight to the brain, where it generates positive sensations, such as pleasure and relaxation. However, the body does not develop antibodies against nicotine, no matter how much or for how long a person smokes. Based on earlier animal studies, NicVAX is a technology that enables the body to develop antibodies to nicotine. We believe that these antibodies, acting much like a sponge, will soak up the nicotine, preventing it from reaching the brain."
"By reducing the amount of nicotine available to stimulate the brain's pleasure centers, an immunized tobacco user would theoretically receive no positive reinforcement from nicotine use," according to Dr. Naso. In pre-clinical animal studies NicVAX generated antibodies that reduced nicotine levels in the brain by up to 64 percent and blocked the effects of nicotine even at relatively high doses.
The phase I clinical trial will examine NicVAX's safety and ability to stimulate the immune system in nonsmokers. During the trial, investigators will randomly assign 20 healthy, nonsmoker adults to receive either NicVAX or a placebo injection. Safety and antibody levels against nicotine will be measured during the study. Neither the investigator nor the subject will know what was injected until the study ends.
Nabi Biopharmaceuticals has planned additional, phase II clinical trials to investigate NicVAX's safety and ability to stimulate immunity in smokers and ex-smokers. If the investigational vaccine performs well in these trials, the company will pursue definitive, phase III trials to evaluate the vaccine's efficacy to treat nicotine addiction and prevent it in people who have not yet started smoking.
At least 1.1 billion people worldwide, a third of the global adult population, use tobacco products which cause 4 million premature deaths annually, according to the World Health Organization. In the United States, tobacco use is the single leading preventable cause of death, causing more than 430,000 deaths each year and tallying an estimated $50 billion in direct medical and $47 billion in indirect non-medical costs.
Development of NicVAX is funded, in part, by grant DA13327 from the National Institute on Drug Abuse.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals discovers, develops, manufactures and markets products that power the immune system to help people with serious, unmet medical needs. The company has a broad product portfolio and significant research capabilities focused on developing and commercializing novel vaccines and antibody-based therapies that prevent and treat infectious, autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, ITP, and nicotine addiction. Nabi Biopharmaceuticals has several products in clinical trials, as well as four marketed products, including Nabi-HB™ [Hepatitis B Immune Globulin (Human)], for the prevention of hepatitis B infections and WinRho SDF (r), [Rho (D) Immune Globulin Intravenous (Human)], for the treatment of acute, chronic and HIV-related immune thrombocytopenia purpura. The company is headquartered in Boca Raton, Florida, with principal R&D offices and laboratories in Rockville, Maryland. Additional information about Nabi Biopharmaceuticals may be obtained on the company's website at www.nabi.com.
This press release contains 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 costs of research and development; dependence upon third parties to manufacture product; the impact on the company of current industry supply and demand factors and the supply of and demand for the company's individual products; future sales growth prospects for its biopharmaceutical products; and 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. These factors are more fully discussed in the company's most recent Form 10-K filed with the Securities and Exchange Commission.