IRVING, Texas, April 15 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that its wholly-owned subsidiary, DelSite Biotechnologies, Inc., entered into a non-exclusive technology evaluation agreement with a global pharmaceutical company for the purpose of evaluating DelSite’s GelSite(R) polymer-based delivery technologies.
The goal of the program is to evaluate DelSite’s parenteral technologies. DelSite has agreed to provide GelSite polymer and technical information concerning the optimal solubilization and mixing conditions. Terms of the agreement were not disclosed.
Carlton E. Turner, PhD, president and CEO of Carrington Laboratories and DelSite Biotechnologies, commented, “DelSite’s technologies are novel and patent-protected, and we are dedicated to developing them for a wide range of applications. This agreement represents another highlight of increased interest in DelSite’s technologies within the pharmaceutical industry.”
DelSite is currently developing a nasal powder H5N1 influenza vaccine based on the GelVac(TM) nasal powder platform. Advantages of the GelVac vaccine delivery platform are: room temperature stability, needle-free administration, no adjuvant requirement, no preservative requirement, no cold-chain distribution, and induction of both systemic and mucosal immunity. DelSite plans to initiate a Phase I clinical study of the flu vaccine with the GelVac platform this summer.
GelSite polymer is a novel, naturally-occurring ionic carbohydrate polymer that is capable of forming a gel upon contact with body fluids. DelSite has developed three novel delivery platforms for various applications: 1) GelVac nasal powder for nasal delivery of vaccines and therapeutics; 2) GelSure(TM) for injectable delivery of therapeutics; and 3) GPDA(TM) depot adjuvant for vaccine applications. GPDA is a unique depot adjuvant; unlike many current adjuvants, it does not stimulate immune cells but achieves the adjuvant effect through sustained antigen release or depot effect.
DelSite has completed a series of toxicology studies on GelSite polymer and the delivery platforms. A Drug Master File (DMF) for use of GelSite polymer was filed in 2005 with both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA).
About DelSite
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 and vaccines. 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 NIAID (National Institute of Allergy and Infectious Diseases) of NIH (National Institutes 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, and wound and oral care. Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP drug standards. 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/DelSite 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.
CONTACT: Carlton E. Turner, PhD, Chief Executive Officer of Carrington
Laboratories, Inc., +1-972-518-1300, or 1-800-527-5216; or Thomas Redington
of Redington, Inc., +1-203-222-7399, or +1-212-926-1733, for Carrington
Laboratories, Inc.
Web site: http://www.carringtonlabs.com/
