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Irving, TX, United States, 2007/02/17 - Carrington Laboratories, Inc. and DelSite Biotechnologies, an innovator in nasal vaccine delivery technology, have discovered that flu vaccines delivered nasally have shown to provide immunity both locally in the nasal passages and nasal mucosa [Nasdaq: C.
Carrington Laboratories, Inc.’s DelSite Biotechnologies subsidiary, an innovator in nasal vaccine delivery technology, said flu vaccines delivered nasally have been shown to provide immunity both locally in the nasal passages and also systemically as the vaccine penetrates the nasal mucosa.
"This feature of double immunity, and the speed with which the nasal passages become protected, can be very beneficial in immunizing children with immature immune systems and older people with weakened immune systems," notes Dr. Yawei Ni, senior scientist at DelSite Biotechnologies.
"The results reported today in The New England Journal Of Medicine on the enhanced efficacy of FluMist®'s, a live attenuated vaccine delivered as a liquid nasal spray, versus standard injected flu vaccines in children between the ages of six months and five years is a very encouraging note for the broader adoption of a nasal vaccine delivery option," he added.
DelSite's nasal powder vaccine delivery platform, called GelVac™, is a nasal powder vaccine delivery platform based on the GelSite® polymer technology. Having recently completed successful human safety Phase I study (with a GelSite® polymer powder system) and earlier preclinical work that established GelVac™’s ability to immunize subjects against severe flu challenges in a series of animal models, the vaccine delivery technology with antigen is scheduled to enter Phase I human testing. The company currently is in the process of acquiring flu antigen in order to initiate the human study.
GelVac™, a nasal powder vaccine delivery platform, based on GelSite® polymer, is a dry powder formulation delivered nasally providing several potential advantages over other systems, including better stability, room temperature storage, no need for preservatives, no need for needles and is mucoadhesive providing prolonged nasal residence time. Nasal immunization induces both systemic and mucosal immune responses. The GelVac™ delivery system increases antigen nasal residence time, providing for prolonged contact with the mucosal surface which may improve immune response for many different classes of antigens.
GelSite® polymer is a naturally sourced, high-molecular-weight anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite® is water-based and is capable of in situ gelation, i.e., changing either a solid or liquid formulation into a gel upon contact with body fluids that leads to controlled-release of active biomolecules. 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 polymer is currently manufactured to cGMP standards at Carrington Laboratories wholly owned subsidiary, Sabila Industrial, SA.
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite® technology designed to provide controlled release of peptide and protein-based drugs. DelSite is currently developing a nasal powder vaccine using its GelVac? formula with the H5N1 avian flu antigen. This work is partially funded by two grants from the Department of Health and Human Services.
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® and cosmetic raw material Hydrapol™. Carrington also manufactures and distributes a complete line of wound care products for the professional veterinarian through its Veterinary Medical Divison (CarraVet™ Wound Care and the new EquineVet® Advanced Wound Therapy for horses). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. DelSite Biotechnologies, a subsidiary of Carrington, is developing its proprietary GelSite® technology designed to provide controlled release of peptide and protein-based drugs. A platform technology for a powder nasal delivery system is being developed for vaccine with emphasis and funding from the US HHS for the H5N1 (Bird Flu) Antigen. 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.
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, 2006.