IRVING, Texas, Dec. 19 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that Yawei Ni, Ph.D., Senior Scientist of its subsidiary DelSite Biotechnologies, Inc., presented data describing results of preclinical studies conducted with its Avian Influenza Vaccine using the GelVac(TM) nasal powder vaccine delivery system at the American Society for Microbiology’s 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Dr. Ni reported that an inactivated influenza nasal powder vaccine, using the GelVac delivery system, demonstrated a strong protective immunity in an animal model against both H5 avian and contemporary influenza virus as measured by serum antibody response. A significant specific immune response was observed after one immunization, with a strong boosting effect following a second immunization. Importantly, the GelVac system appears to demonstrate both antigen-sparing and antigen stabilization effects. The Conference was held December 16-19, 2005 in Washington, D.C. The poster presentation is titled “Induction of Protective Immunity against Influenza Virus with A Nasal Powder Vaccine Delivery System (GelVac(TM))”.
The GelVac nasal powder vaccine delivery system is DelSite’s most advanced delivery platform using the GelSite(R) polymer. In May 2005, DelSite announced results of a Phase I clinical trial involving 15 healthy volunteers that demonstrated that the GelVac system was safe and well tolerated and that doses were consistently and reproducibly delivered to the nasal cavity. The GelSite polymer can be produced in kilo quantities at Carrington’s bulk pharmaceutical manufacturing facility in Costa Rica.
A Drug Master File (DMF) for use of GelSite polymer in mucosal applications was recently filed with the FDA. Development of the GelVac nasal powder vaccine delivery system is partially supported by an SBIR biodefense grant and a $6 million NIH/NIAID preclinical development grant for H5N1 avian influenza.
About GelSite(R) and GelVac(TM)
The GelVac powder delivery system is based on the proprietary GelSite polymer, a high molecular weight ionic polysaccharide that exhibits distinct chemical and functional properties. GelSite polymer is also capable of in situ gelation, i.e., changing from a liquid or a powder to a gel upon contact with body fluids.
GelSite nasal powder formulations have the potential to be used for the delivery of vaccine antigens as well as therapeutic agents. GelSite is not an adjuvant and is a member of a family of plant polysaccharides classified by the FDA as Generally Regarded as Safe (GRAS).
The GelVac system is a nasal powder vaccine delivery platform based on GelSite polymer. This system provides several potential advantages, including better stability, room temperature storage and no need for preservatives. Additionally, nasal immunization induces both systemic and mucosal immune responses and is needle-free, with the potential for self-administration in the event of a pandemic.
About DelSite
DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington Laboratories, was established to commercialize its novel polymer drug delivery technology. Currently, DelSite is focused on developing delivery systems for vaccines and therapeutic proteins and peptides that could benefit from improved intranasal, topical and injectable routes of administration. For more information please visit http://www.delsite.com .
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. The Company’s DelSite Biotechnologies subsidiary is developing its proprietary GelSite(R) technology 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 .
Certain statements in this release concerning Carrington may be forward-looking. Actual events will be dependent upon a number of factors and risks including, but not limited to: subsequent changes in plans by the Company’s management; delays or problems in formulation, manufacturing, distribution, production and/or launch of new finished products; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company’s filings with the Securities & Exchange Commission, including the Form 10-Q, filed November 14, 2005.
Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300
