GelVac(TM) Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicolo... (tigen in the GelVac(TM) formulationhas b...)

GelVac(TM) Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicology Studies

Date:1/15/2008

tigen in the GelVac(TM) formulation has been stable at ambient room temperature for 36 months.

The nasal cavity is increasingly recognized as the ideal immunization route since most infectious diseases enter the body through mucosal surfaces such as those found in the nasal cavity, the lungs, and the intestines. Nasal immunization not only induces a systemic response, but also induces mucosal response, providing protection at the entry point. GelVac(TM) is a novel in- situ gelling powder formulation for nasal delivery. The GelSite(R) polymer enables in-situ gelling of the vaccine powder, which changes into gel particles upon exposure to nasal fluids present in the nasal passage. This gel adheres to the mucosal lining and provides prolonged residence time and sustained antigen release that, in turn, increase antigen delivery.

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 Institutes of Health) under the Department of Health and Human Services.

A Drug Master File (DMF) has been filed with the FDA for GelSite(R) polymer which may be made in kilogram quantities under cGMP guidelines in an ISO-certified facility.

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). Ca
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GelVac(TM) Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicolo...(tigen in the GelVac(TM) formulationhas b...)