IRVING, Texas, Dec. 10 /PRNewswire-FirstCall/ -- An experimental drug delivery technology from the DelSite Biotechnologies subsidiary of Carrington Laboratories, Inc. may help cut significant waste from the federal pediatric vaccine program, while greatly expanding the use of needle-less vaccines here and abroad.
The Associated Press last week reported that Lance E. Rodewald, MD, director of the Immunization Services division at the Centers for Disease Control and Prevention, said improper refrigeration is the single biggest problem causing waste in the $2-billion-a-year federal Vaccines for Children Program (VFC).
The new vaccine technology from Texas-based DelSite is the first of its class to eliminate the need for refrigerated storage. The DelSite technology formulates vaccines in a fine powder that may be stored and shipped at room temperature. The vaccine product may be administered nasally in a super-fine powder mist, or it may also be reconstituted into liquid form for conventional injections.
Once considered to be a marginal product, nasal versions of flu vaccines are gaining popularity, especially among parents of young children and with elderly people -- two age groups that tend to be skittish about needles. AstraZeneca, the makers of FluMist(R), the only currently approved nasal flu vaccine, expects higher US sales this flu season due to a switch from frozen to refrigerated storage and a just revised FDA label that now allows use in children under five. Last Friday, AstraZeneca announced plans to file for approval for FluMist in Europe and to accelerate its launch in the rest of the world.
Compared to FluMist, which is made of a live vaccine antigen in a liquid formulation, DelSite's nasal powder technology differs in several potentially important ways:
* DelSite-enhanced powder vaccines require no refrigerated shipping or storage.
* DelSite-enhanced powder vaccines make use of inactivated vaccine antigen and provide both nasal and systemic immunization.
* The composition of DelSite-enhanced vaccines confers adjuvant-like properties, boosting immunostimulation and potentially enabling lower dosing.
DelSite's nasal powder, which is expected to enter human clinical trials for effectiveness against flu early next year, is based on a chemically and functionally distinct high-molecular-weight ionic polysaccharide designed for in situ gelling. The polymer allows dry powder to change into gel particles upon contact with liquids in the nasal cavity. The in-situ gel provides sustained antigen release and prolonged nasal residence, thereby increasing exposure to the antigen that results in increased immune response.
There is a significant unmet global health need for influenza vaccines. All current influenza vaccines are liquid formulations that have a limited shelf life, require refrigeration for storage and distribution and, with the exception of one live vaccine product, are administered by injection.
DelSite's nasal powder influenza vaccine holds distinct advantages over current flu vaccines by providing long-term stability at room temperature, shipping and distribution with no need for refrigeration, and administration without a needle. In addition, the vaccine is preservative-free and induces both mucosal and systemic responses. These attributes make DelSite's nasal powder influenza vaccine particularly well suited for pandemic preparedness when such products may need to be stockpiled for extended periods of time and rapidly distributed and self administered under emergency conditions.
Once DelSite's nasal dry powder technology has been successfully developed for the influenza vaccine, these same advantages may also prove useful in formulating other biodefense products and a wide range of other vaccines to improve their storage and distribution, administration, and effectiveness.
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company currently utilizing naturally- occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. Carrington's DelSite Biotechnologies subsidiary is developing its proprietary GelSite(R) technology which is designed to provide controlled release of peptide and protein-based drugs. Carrington's technology is protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. For more information, visit http://www.carringtonlabs.com.
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc., is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs and vaccines. DelSite is currently developing a nasal powder vaccine using its GelVac(TM) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from NIAID (National Institute of Allergy and Infectious Diseases) of NIH (National Institute of Health) under the Department of Health and Human Services.
Carrington Laboratories, Inc.
Carlton Turner, Ph.D., +1-972-518-1300
CONTACT: Carlton Turner, Ph.D., of Carrington Laboratories, Inc.,
Web site: http://www.carringtonlabs.com/