Carrington Laboratories Granted European Patent For Drug Delivery Technology
IRVING, Texas, Nov. 30 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that the European Patent Office has issued European Patent No. EP 1 086 141 B1 titled "Aloe Pectins" relating to the Company's proprietary GelSite(R) polymer technology. DelSite Biotechnologies, Inc., Carrington's wholly-owned subsidiary, is developing and commercializing GelSite polymer as a controlled-release drug delivery technology for pharmaceutical and vaccine products.
The newly issued patent describes the basic composition and process of manufacturing high-molecular-weight and low-molecular-weight pectins from Aloe vera. The claims of this patent are broadly applicable to any use of DelSite's Aloe pectins, including use in pharmaceutical compositions including proteins, peptides, vaccine antigens and other pharmacological substances.
"DelSite continues to build a strong intellectual property estate around our proprietary drug delivery technologies and we are pleased to receive the first European patent for GelSite polymer," said Kenneth Yates, president of DelSite Biotechnologies. "GelSite polymer has unique functional properties such as in situ gellation and the ability to stabilize many proteins that make it an attractive basis for novel drug delivery systems, including the GelVac(TM) nasal powder vaccine delivery system."
DelSite's most advanced delivery platform is the GelVac nasal powder vaccine delivery system based on GelSite polymer. GelVac is a simple and broad nasal powder vaccine delivery platform suitable for many different classes of vaccine antigens. In May 2005, DelSite announced results of a Phase I clinical trial involving 15 healthy volunteers that demonstrated that the GelSite polymer and the GelVac 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 polymer in mucosal applications was recently filed with the FDA. Currently, preclinical development is progressing for a GelVac nasal powder avian influenza (bird flu) vaccine.
About GelSite(R) and GelVac(TM)
GelSite polymer is a naturally sourced, high molecular weight anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite is water-based and is capable of in situ gelation, i.e., changing either a solid or liquid formulation into a gel upon contact with body fluids leading to controlled-release of active biomolecules. GelSite is not an adjuvant and is a member of a family of plant polysaccharides classified by the FDA as Generally Regarded As Safe (GRAS). The polymer is currently manufactured to cGMP standards at Carrington's wholly-owned subsidiary, Sabila Industrial, S.A., in Costa Rica.
The GelVac system is a nasal powder vaccine delivery platform based on GelSite polymer. Dry powder formulations delivered nasally provide several potential advantages, including better stability, room temperature storage, no need for preservatives, no need for needles and mucoadhesive. Nasal immunization induces both systemic and mucosal immune responses. The GelVac delivery system increases antigen nasal residence time providing for prolonged contact with the mucosal surface, which may improve immune response for many different classes of antigens.
About DelSite
DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington Laboratories, was established to commercialize its novel polymer drug delivery technology. Currently, DelSite is focused on developing delivery systems for vaccines and therapeutic proteins and peptides that could benefit from improved nasal, topical and injectable routes of administration. For more information, visit http://www.delsite.com .
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 under the AloeCeuticals(R) brand and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. The Company'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 are honored with the internationally coveted 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, 2005.
Carrington(R), Manapol(R), AloeCeuticals(R), Hydrapol(TM), GelSite(R) and GelVac(TM) are trademarks, registered trademarks or service marks of Carrington Laboratories, Inc., in the United States and/or other countries. All other trademarks or service marks contained herein are the properties of their respective owners.
Carrington Laboratories, Inc.CONTACT: Carlton E. Turner, Chief Executive Officer of CarringtonLaboratories, Inc., +1-972-518-1300