IRVING, Texas, March 28 /PRNewswire-FirstCall/ -- Carrington Laboratories Inc. today announced its wholly-owned subsidiary DelSite Biotechnologies, Inc. has entered into a collaborative agreement with the International Vaccine Institute (IVI) to evaluate DelSite's drug delivery technology for sublingual vaccines that can be used for needle-free immunization programs in needy areas of the developing world.
IVI is an internationally renowned organization that was established ten years ago at the initiative of the United Nations Development Program to accelerate development and introduction of new and existing vaccines for poor populations of the developing world and to transfer new technologies to vaccine producers.
The collaborative agreement states "[DelSite's] polymer is capable of gelling in-situ in contact with body fluids, including the oral fluid, and is mucoadhesive, which together provide the formulation prolonged residence time and a sustained antigen release. In addition, the polymer has an antigen stabilization effect. The formulation can be prepared in various forms - a liquid, a soft gel, a powder, or a dried pad."
Under the collaboration, during the next twelve months, Carrington will formulate vaccine antigens supplied by IVI for sublingual delivery and IVI will conduct animal testing. The target vaccine antigens and formulation forms will be selected by mutual agreement.
During the term of the agreement, DelSite has agreed to not enter into another agreement to use GelSite(R), its polymer delivery technology for sublingual vaccines, without the consent of IVI. Arrangements for commercial development and marketing of vaccines candidates generated by the collaboration would be decided upon by Carrington and IVI as equal joint owners of the prospective products.
"We are very enthusiastic about the program and clearly hopeful that DelSite's polymer delivery technology will help make the sublingual delivery of vaccines a reality and expand the availability of critical vaccines to countries or places with great need," said Yawei Ni, Ph.D., senior scientist. "Sublingual technology would allow for needle-free self-administration of the vaccines which should significantly reduce the number of trained professionals typically required for large immunization programs. Additionally, vaccines made with DelSite technology could be delivered without cold-chain storage, thereby facilitating vaccine distribution into remote communities where lack of refrigeration rules out the use of most current vaccines."
Dr. Turner, President and CEO of Carrington Laboratories, Inc., added that IVI's interest in the GelSite(R) technology as well as other recently announced agreements -- with EndoBiologics of Missoula, Montana for the use of GelSite(R) in development of a vaccine for bacillary dysentery (shigellosis); with AriaVax of Gaithersburg, Maryland for an HIV vaccine; and with ElSohly Labs of Oxford, Mississippi to use GelSite(R) formulating an anticancer drug - - demonstrates the versatility of DelSite's platform technology for delivering vaccines and therapeutic agent. DelSite's nasal powder vaccine delivery platform is also being evaluated as a delivery system for an H5N1 pandemic influenza vaccine, partially supported by a NIH/NIAID Challenge Grant, and under a CRADA with the NCI, DelSite is investigating its utility for nasal delivery of an HPV vaccine.
About International Vaccine Institute
The International Vaccine Institute (IVI) is located in Seoul, South Korea (http://www.ivi.org ). The IVI is the world's only international organization devoted exclusively to developing and introducing new-generation vaccines to protect the world's poorest people, especially children in developing countries. Established at the initiative of the United Nations Development Program, the IVI operates under a treaty signed by 39 countries and the World Health Organization, and conducts research in more than 20 countries of Asia, Africa and Latin America.
About DelSite
DelSite, founded in late 2001, is a wholly-owned subsidiary of Carrington Laboratories Inc. DelSite is dedicated to research efforts to develop the GelSite(R) polymer as a delivery system for protein and peptides with emphasis on a nasal powder delivery system free of preservatives, stable at room temperature, requires no cold storage, and can be administered by non- healthcare professionals. GelSite(R), a negative charged carbohydrate polymer, is produced under cGMP in kilo quantities in Carrington's bulk pharmaceutical plant in Costa Rica.
DelSite previously announced results of a Phase I clinical trial involving healthy volunteers that demonstrated that GelSite(R) polymer and the GelVac(TM) system was safe and well tolerated and that doses were consistently and reproducibly delivered to the nasal cavity.
A Drug Master File (DMF) for use of GelSite(R) polymer in mucosal applications was filed in 2005 and recently updated with both Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) of Food and Drug Administration (FDA). Currently, preclinical development is progressing for a GelVac(TM) nasal powder avian influenza (bird flu, H5N1) vaccine.
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 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 November 14, 2006.
Carrington Laboratories, Inc.CONTACT: Yawei Ni, PhD of DelSite Biotechnologies, Inc., +1-972-518-1300;or Dr. Cecil Czerkinsky of International Vaccine Institute,cczerkinsky@ivi.int
