Aktiv-Dry LLC, a biotechnology company dedicated to developing inhalable aerosol vaccines, has been awarded a $850,000 SBIR grant from the National Institute on Drug Abuse at the National Institutes of Health to develop an inhalable nicotine vaccine

Aktiv-Dry LLC, a biotechnology company dedicated to developing inhalable aerosol vaccines, has been awarded a $850,000 SBIR grant from the National Institute on Drug Abuse at the National Institutes of Health to develop an inhalable nicotine vaccine to help smokers quit smoking for good. Jim Searles, Ph.D., of Aktiv-Dry, will be the principal investigator; Nabi Biopharmaceuticals and the Minnesota Medical Research Foundation will be collaborators. The SBIR grant is a Fast Track award to fund Phase I and Phase II activities. According to the U.S. Centers for Disease Control and Prevention (CDC), tobacco use is the single leading preventable cause of death in the U.S. and is responsible for more than 440,000 deaths each year. The CDC estimates that approximately 70 percent to 80 percent of smokers in the U.S. want to quit, but less than five percent of those who try to quit remain smoke-free at 12 months. "The overall approach of the project is really quite simple," said Brian Quinn, Ph.D, president of Aktiv-Dry. "We will reformulate Nabi's NicVAX(R) injectable vaccine as a stable, dry powder consisting of particles -- 1 to 3 microns in diameter -- that humans can inhale and that can easily be delivered to the lungs," said Quinn. NicVAX, Nabi's proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, is designed to stimulate the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain. It is believed that these nicotine antibodies will act like a "sponge" soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain. The positive stimulus in the brain that is normally caused by nicotine is no longer present, thereby eliminating the addictive properties of nicotine and, consequently, helping people to quit. Because the ability of the body's immune system to produce these antibodies is expected to be long lasting, it is believed NicVAX will also be effective in preventing smoking relapse, a significant challenge with existing smoking cessation therapies. By preventing the pleasurable response ("the rush") that occurs when nicotine reaches the brain, NicVAX takes away what is believed to be the main reason that most people cannot stop smoking. Although needles and syringes are most commonly used to administer vaccines, international authorities recognize a growing need for "needle-free" alternative methods to avoid inadvertent disease from contaminated needles, accidental needle-sticks, thermal instability of current formulations, and increase compliance with vaccination regimens. Aktiv-Dry has developed a supercritical carbon dioxide technology to manufacture pharmaceutically active microparticles used in vaccines that are suitable in size and stability for humans to inhale. Using Aktiv-Dry's "needle-free" technology to deliver NicVAX to the respiratory tract is expected to facilitate patient compliance, enhance the efficacy of a nicotine vaccine, and address potential issues with distribution and use on a world-wide basis. About Aktiv-Dry LLC Aktiv-Dry LLC was founded in 2002 by University of Colorado Professors Robert Sievers and John Carpenter, and also by Brian Quinn, Ph.D., to develop life-saving stable vaccines and pharmaceuticals for needle-free delivery. The company currently engages in research and development projects for dry powder applications and contracts with industrial, governmental, and not-for-profit clients. Aktiv-Dry was awarded a $19.5 million grant in 2006 by the Grand Challenges in Global Health initiative to develop an inhalable measles vaccine. Aktiv-Dry LLC

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