DelSite Nasal Powder Technology Could Reduce Recently Reported Waste in Federal Vaccine Program

'Room Temp' Technology Builds on Consumer Appeal and Tactical Importance of

Needle-less Vaccinations

    IRVING, Texas, Dec. 10 /PRNewswire-FirstCall/ -- An experimental drug
 delivery technology from the DelSite Biotechnologies subsidiary of
 Carrington Laboratories, Inc. (OTC Bulletin Board: CARN) 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.
 
     About Carrington
 
     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.
 
     About DelSite
 
     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.
 
     Contact:
 
     Carrington Laboratories, Inc.
 
     Carlton Turner, Ph.D., +1-972-518-1300
 
 
 

SOURCE Carrington Laboratories, Inc.