IRVING, Texas, April 19 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced its wholly-owned subsidiary, DelSite Biotechnologies, Inc., has secured a source of influenza antigen for a planned Phase I Clinical Trial of a novel nasal powder influenza vaccine based on its GelVac(TM) dry powder technology. The GelVac(TM) powder contains the unique and enabling in situ gelling GelSite(R) polymer that is manufactured by DelSite. This vaccine provides distinct potential advantages that could meet the critical needs for pandemic preparedness and epidemic control, including room temperature stability, prolonged shelf life, distribution without refrigeration, and needle-free administration.
A Pre-IND meeting with the FDA on this nasal powder vaccine was completed in November of 2006. Toxicology study protocols relevant to this vaccine are being reviewed at the FDA. Pending successful toxicological studies, this will be the first influenza nasal powder vaccine to be used in a human clinical trial. The GelVac(TM) system requires no organic solvent in the manufacturing process, uses no preservatives, and does not require refrigeration. It also gels in situ and is mucoadhesive, providing prolonged nasal residence time and thus increasing antigen delivery. Additionally both systemic and mucosal immunity are induced with nasal immunization.
Dr. Yawei Ni, senior scientist at DelSite, stated, "The effectiveness of GelVac(TM) nasal powder influenza vaccine has been well demonstrated in our preclinical studies. Previously, we completed a Phase I human safety study on GelVac(TM) powder system (without antigen) with results that form the basis for this upcoming Phase I study. In addition, GelVac(TM) powder with influenza antigens has been stable at ambient room temperature for over two years, which has positive implication for future stockpiling of vaccines for pandemic use."
Carlton E. Turner, CEO of Carrington said, "The acquisition of a GLP and cGMP antigen relieves us of the expense of producing an antigen using our viral and cell banks. Thus, we can invest these funds toward the needs for the Phase I trial. In March of 2006, briefings were held with key members of Congress, relevant Congressional Hill Committee staffers, and policy makers at HHS on DelSite's nasal powder vaccine technology. DelSite was asked if it were possible, for national preparedness, to develop the dry powder nasal technology faster than the milestones required by NIH grants supporting our platform and pandemic bird flu (H5N1) influenza vaccine program. I accepted the challenge to use Carrington funds and accelerate our nasal delivery vaccine program. The acquisition of this antigen furthers our ability to meet my commitment to members of Congress, their Committees and policy makers. Nothing is definite until clinical results are analyzed, but based on the strength of our technologies, I believe our shareholders will get great value out of this program. And our nation will have another tool in its arsenal to vaccinate and protect our citizens in pandemic or routine seasonal influenza needs."
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.
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 designed to provide controlled release of peptide and protein-based drugs and vaccines. 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-K, filed April 2, 2007.
Carrington Laboratories, Inc.CONTACT: Dr. Yawei Ni, Senior Scientist of DelSite, yni@delsite.com
Web site: http://www.carringtonlabs.com/
