Carrington Laboratories, Inc. Gets Added U.S. Patent Protection For Antigen Sparing Influenza Vaccines
IRVING, Texas, May 18 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that it has received a U.S. Patent which describes pharmacological compositions that expand the Company's technology base and help protect the antigen sparing influenza vaccines which DelSite Biotechnologies, Inc., Carrington's wholly-owned subsidiary, is developing and commercializing.
Potential influenza vaccine shortages during seasonal epidemics, as well as possible pandemic outbreaks, are of major concern, requiring new methods and technologies to expand the influenza vaccine supply. DelSite has shown in preclinical studies that combining GelSite(R) polymer with influenza antigens leads to a significant antigen sparing effect, reducing the amount (dose) of antigen required for protective immunity.
Based on animal (preclinical) data with the avian flu antigen, DelSite's technology allows for reduction in the (standard) amount of antigen needed for protection by a factor of up to 16. Thus, one million standard (15 micrograms HA) doses, theoretically, can be expanded to 16 million doses, using the DelSite formulation. This technology is the basis of DelSite's response to the government's recent request for proposal (RFP) for the development of an antigen-sparing pandemic flu vaccine.
The patent entitled "Pharmacological compositions comprising pectins having high molecular weights and low degrees of methoxylation" adds to an existing, strong patent position for DelSite's GelSite(R) polymer-based drug delivery technologies. "This patent is critical to move DelSite forward as a drug delivery company," said Carlton Turner, president and CEO of Carrington Laboratories. "DelSite's sustained release and powder delivery technology for nasal as well as injectable vaccines and drugs is the foundation and strength of the Company."
GelSite(R) polymer is being developed as a controlled-release drug delivery technology for pharmaceutical and vaccine products. DelSite is currently developing new vaccines for seasonal as well as pandemic (avian) influenza.
DelSite has developed a proprietary GelVac(TM) nasal powder delivery system for vaccines based on GelSite(R) polymer. The company is actively pursuing a nasal powder avian influenza vaccine using this system. This activity is partially supported by a $6 million NIH/NIAID preclinical development grant for H5N1 avian influenza.
About GelVac(TM) Nasal Powder Influenza Vaccine
DelSite's GelVac(TM) avian 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 stock-piling 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.
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-Q on May 4, 2006.Carrington Laboratories, Inc.
CONTACT: Carlton E. Turner, CEO, for Carrington Laboratories, Inc.,+1-972-518-1300
Web site: http://www.carringtonlabs.com/