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Development of a Micronized Needle-Free Nicotine Vaccine for Smoking Cessation…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
80865
Program Year/Program:
2008 / SBIR
Agency Tracking Number:
DA022096
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
AKTIV-DRY
2100 Central Ave., Suite 109 Boulder, CO 80301-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2008
Title: Development of a Micronized Needle-Free Nicotine Vaccine for Smoking Cessation an
Agency: HHS
Contract: 4R44DA022096-02
Award Amount: $823,623.00
 

Abstract:

DESCRIPTION (provided by applicant): Aktiv-Dry LLC, in collaboration with Nabi Biopharmaceuticals, proposes to develop and evaluate in animal models the needle-free respiratory delivery of fine dry powder nicotine vaccine. While syringe and needle have bee n a common vaccine administration mechanism, international authorities recognize a growing requirement for alternative formulations and delivery systems, especially because of inadvertent disease from needle contamination, accidental needle-sticks, thermal instability of current formulations, and compliance with vaccination regimens. Nicotine is primarily responsible for the psychoactive and addictive effects of smoking. Immunotherapy has already been shown to be useful in prevention and/or treatment of add iction to nicotine and other drugs of abuse. Nicotine-specific antibodies can bind and sequester nicotine in the serum, thus preventing nicotine from reaching the brain as antibodies are too large to cross the blood-brain barrier. A number of studies have shown that, in animals, NicVAX(tm), a nicotine-carrier protein conjugate vaccine, reduces the distribution of nicotine to the brain, attenuates the locomotor and stimulus properties of nicotine and prevents nicotine from relieving nicotine abstinence syndr ome. In humans, such a vaccine may be an effective aid in smoking cessation and reduce the rate/extend the time to relapse. Nabi has already demonstrated the safety and immunogenicity of NicVAX(tm) in humans and established its potential as a useful therap eutic and preventative agent to assist in smoking cessation/abstinence and prophylaxis. Aktiv-Dry has developed a technology to manufacture pharmaceutically active microparticles suitable in size and stability for delivery by inhalation. Delivery of NicVAX (tm) by a needle-free approach to the respiratory tract using the Aktiv-Dry technology may facilitate patient compliance, address potential issues with distribution and use on a world-wide basis, and possibly enhance the efficacy of a nicotine vaccine.

Principal Investigator:

Business Contact:


bquinn@aktiv-dry.com
Small Business Information at Submission:

AKTIV-DRY, LLC
AKTIV-DRY, LLC 6060 SPINE RD BOULDER, CO 80302

EIN/Tax ID: 752993463
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No