DelSite Biotechnologies, Inc. Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
IRVING, Texas, Aug. 15 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced its subsidiary DelSite Biotechnologies, Inc. has initiated the animal toxicology studies of its GelVac(TM) nasal powder influenza vaccine, incorporating an H5N1 (bird flu) antigen.
The toxicology studies are a critical step during the vaccine development and will assess the vaccine safety in animals. Pending successful results of the toxicology studies and discussion with the antigen supplier, DelSite will file an IND for a phase I human safety study of the GelVac(TM) nasal powder H5N1 vaccine in late 2007. The toxicology studies are being conducted at a well-known contract research organization, using study protocols that have been reviewed by FDA. The GLP vaccine test articles were prepared and shipped to the study site according to the schedule established after receipt of the H5N1 antigen.
GelVac(TM) nasal powder platform is a novel, in-situ gelling powder formulation based on its GelSite(R) polymer technologies. A phase I human safety study on this platform (without an antigen) has been completed and found the platform safe and well tolerated. Preclinical studies with influenza antigen have shown that the nasal powder influenza vaccine is not only effective, but also provides distinct logistic advantages including room temperature stability and refrigeration-free distribution that are critical to pandemic preparedness.
Dr. Carlton Turner, CEO, commented, "With initiation of the animal toxicology studies, we have reached an important milestone for development of this first nasal powder influenza vaccine. Our team has done an outstanding job under a very tight schedule to produce the test materials and complete all logistic tasks for the study initiation. We anticipate the filing of IND paperwork before the end of 2007."
The development of GelVac(TM) nasal powder bird flu vaccine 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. 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 August 14, 2007.
Carrington Laboratories, Inc.CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300
Web site: http://www.carringtonlabs.com/