IRVING, Texas, Jan. 18 /PRNewswire-FirstCall/ -- In view of a recent article in the January 16, 2007 Wall Street Journal about a “Permanent Threat” regarding the risk of an H5N1 (bird flu) pandemic and recent incidence of human cases in Vietnam and China, Carrington Laboratories, Inc. today issued a status report on DelSite Biotechnologies, Inc.'s influenza vaccine development. DelSite, a wholly-owned subsidiary of Carrington, has been developing a platform for the development of a vaccine for an H5N1 flu pandemic with funding from the National Institute of Allergy and Infectious Disease, Department of Human Health Services (NIAID, DHHS). GelVac(TM) is the platform for nasal powder delivery of preservative-free vaccines that requires no freezing or cold storage transport system; thus, distribution will not be limited to developed countries that have cold chain distribution systems.
The core component in GelVac(TM) is a unique, natural carbohydrate polymer (GelSite(R)) which is manufactured under cGMP guidelines as required by the FDA in Carrington’s ISO-certified, bulk pharmaceutical plant in Costa Rica. The GelSite(R) polymer is produced in kilo quantities and is formulated without using organic solvents, thus never exposing the body to undesirable chemicals. The GelSite(R) polymer, when used in powder formulations with influenza antigens, stabilizes the vaccine antigen. Formulations can be stored at room temperature without loss of potency for over two years as measured by hemagglutination activity (HA). When delivered into the nasal cavity, the powder particles change into adhesive gel particles upon contact with nasal fluid that provide prolonged nasal residence time and slowly release the antigen. This slow release increases the body’s immune response. Unlike an injectable influenza vaccine which only imparts systemic immunity, the nasal immunization provides both systemic and mucosal immunity.
A Phase I human safety trial using GelVac(TM) formulation without an antigen has been completed and demonstrated the safety of the polymer and efficiency of the delivery device. Additionally, the study confirmed that the powder stayed in the nasal cavity, and subjects indicated powder delivery was more desirable than injections. A Drug Master File (DMF) on GelSite(R) polymer was filed with the drug and biologics divisions of the FDA and updated in September 2006.
GelVac(TM) formulated powder can be stored at room temperature for an extended period of time and delivered as a nasal powder, or reconstituted with sterile water for delivery via classical injection route, thus providing options for delivery depending on the specific needs.
Federal funding for DelSite’s development of the pandemic H5N1 (bird flu) vaccine calls for a cell based antigen which has fewer side effects than classical egg-based antigens. In this connection, DelSite has established its own GMP cell banks and viral banks and will be producing antigens for animal toxicology studies, a key requirement for future clinical studies.
Since the whole influenza virus antigen provides a greater response by the body immune system than partial virus components (split virion), DelSite has developed a process to produce highly purified cell-based whole virion antigen and has filed a patent for this discovery. It is believed that this process will also be applicable to non influenza cell-based antigens.
No cell-based antigens have been approved to date by FDA for any influenza vaccines. Thus, while DelSite continues the development program with cell- based antigen, to expedite acquisition of human clinical data for the GelVac(TM) delivery system, DelSite, using internal funds, is aggressively moving forward with plans to use an egg-based antigen that is currently approved for human use by the FDA.
Pre-IND documents were filed with the FDA and a meeting was held with the FDA in November 2006. DelSite is now actively involved in acquiring egg-based antigens. Once egg-based antigens are acquired, toxicology as agreed to with the FDA, will be done. DelSite has the technology to produce human clinical supplies at its research facilities located at Research Park of Texas A&M University. It is anticipated that the human trial will begin in late 2007.
DelSite’s goal is to have human clinical data whereby this technology can be made available to policy makers for use in biodefense and pandemic preparedness by mid to late 2008.
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. 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 the Department of Health and Human Services. In September 2006 DelSite entered into a three-year CRADA with the Laboratory of Cellular Oncology at the National Cancer Institute (NCI) to determine if GelVac(TM) nasal powder delivery platform is adaptable for delivering human papillomavirus virus-like particles (HPV VLP) vaccines in a powder dosage form for mucosal immunization.
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 and DelSite technologies are 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, 2006.
Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300
Web site: http://www.carringtonlabs.com/
