IRVING, Texas, April 11 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that Dr. Yawei Ni, senior scientist at DelSite Biotechnologies, has presented details of Delsite’s innovative GelVac(TM) technology to industry leaders and investors at the Biotechnology Industry Organization Annual International Convention in Chicago, Illinois.
Dr. Ni’s presentation, selected for the Convention’s “Innovation Corridor” session, provided details of the new and improved GelVac(TM) influenza vaccine. The GelVac(TM) vaccine is designed to offer a combination of distinct advantages not available with other systems, including the potential to reduce the vaccine supply problems emerging with the threat of pandemic influenza.
“Because GelVac(TM) vaccines contain no preservatives and are stable at room temperature for prolonged periods, they can be distributed without refrigeration through regular distribution channels and can easily be stockpiled until needed,” said Dr. Carlton Turner, President & CEO, Carrington Laboratories. He continued, “In the case of a global flu pandemic, GelVac(TM) can be rapidly shipped to ensure efficient inoculation of our population.”
Dr. Ni presented details of GelVac(TM) influenza vaccine incorporating inactivated whole virion antigen that is prepared using a cell based production system and an improved purification process. Data obtained in animal models demonstrated that the GelVac(TM) influenza vaccine induces a strong and prolonged protective immunity against influenza virus and importantly, a strong and protective immunity with avian H5 whole virion antigen.
An abstract of Dr. Ni’s presentation is available on DelSite’s website at http://www.delsite.com/newfiles/bio_ni_april_06.html .
The GelVac(TM) nasal powder vaccine delivery system is DelSite’s most advanced delivery platform. In May 2005, DelSite announced results of a Phase I clinical trial involving healthy volunteers in a double-blind, crossover design that demonstrated that the GelVac(TM) system (without antigen) was safe and well tolerated, and that doses were delivered consistently and reproducibly to the nasal cavity.
Development of the GelVac(TM) influenza vaccine is partially supported by a NIH/NIAID SBIR biodefense grant and a $6 million challenge grant.
About GelVac(TM) Nasal Powder Influenza Vaccine
DelSite’s GelVac(TM) flu vaccine is uniquely suited to meeting the challenges of a pandemic:
* It is stable at room temperature; the vaccine requires no refrigeration for shipping or prolonged storage, facilitating both stockpiling and rapid distribution. * The powder is easily administered and could be self-administered, if necessitated by an overwhelmed health care system. * The powder gels on contact with nasal fluid, prolonging the nasal residence time and sustaining the antigen release potentially allowing for an enhanced protection.
Nasally administered vaccines form a first-line of immune defense for the upper respiratory system, a common entry point for influenza virus, as well as prompting the body’s normal systemic immune response.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based biopharmaceutical company currently utilizing naturally-occurring complex carbohydrates to:
* manufacture and market products for mucositis, radiation dermatitis, wound and oral care; * manufacture and market the nutraceutical and cosmetic raw materials Manapol(R) and Hydrapol(TM); and, * market consumer products under various brands. About DelSite
DelSite Biotechnologies, Inc. was formed based on discoveries at Carrington Laboratories, Inc., and is a wholly-owned subsidiary of Carrington. DelSite Biotechnologies is a drug delivery and biotechnology company established to provide the pharmaceutical and biotechnology industries with novel delivery solutions for vaccines and therapeutic agents.
About GelVac(TM) Delivery System
The GelVac(TM) system is a proprietary nasal powder vaccine delivery system, based on the GelSite(R) polymer, the primary functional ingredient. Dry powder formulations provide several potential advantages including better stability, room temperature storage and no need for mercury or other preservatives. Nasal immunization induces both systemic and mucosal immune responses.
About GelSite(R) Polymer
Carrington’s patented GelSite(R) polymer, extracted and purified from the Aloe vera plant, is a member of a family of carbohydrates that the U.S. Food and Drug Administration has classified as “Generally Regarded As Safe” (GRAS). It is water-based and capable of changing from a solid or liquid into a gel upon contact with body fluid -- a process called in situ gelation -- making possible the sustained release of vaccines and other pharmaceuticals over prolonged periods of time.
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 on March 31, 2006.
Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, CEO of Carrington Laboratories, Inc.,+1-972-518-1300
