IRVING, Texas, Feb. 11 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced that the Eurasian Patent Office has granted patent application No. 200600484, titled "Delivery of Physiological Agents with In-Situ Gels Comprising Anionic Polysaccharides," relating to the Company's proprietary GelSite(R) polymer technology. DelSite Biotechnologies, Inc., Carrington's wholly owned subsidiary, is developing and commercializing GelSite(R) polymer as a controlled-release drug delivery technology for pharmaceutical and vaccine products.
The Eurasian Patent Office, located in Moscow, represents nine Eurasian countries with a combined population of more than 200 million people. The countries in the region include: Turkmenistan, the Republic of Belarus, the Republic of Tajikistan, the Russian Federation, the Azerbaijan Republic, the Republic of Kazakhstan, the Kirghiz Republic (Kyrgyzstan), the Republic of Armenia, and the Republic of Moldova.
The patent specifically covers the in-situ gelation (gelling in place) powder technology based on GelSite(R) polymer. GelVac(TM), the Company's nasal powder platform developed based on this technology, is being developed for nasal delivery of vaccines and therapeutics. The GelVac(TM) platform holds distinct advantages over traditional drug delivery methods, including room temperature stability, no requirement for cold storage and distribution, no need for preservatives, and self-administration. The Company's lead product candidate, GelVac(TM) nasal powder vaccine for influenza H5N1 (avian flu), has passed animal toxicology studies and a Phase I clinical study is planned for 2008.
"This patent reflects our desire to protect intellectual properties in all the countries where we believe DelSite's delivery system will provide competitive advantages," said Carlton E. Turner, PhD, CEO of Carrington. "DelSite's technology enables production of vaccines or therapeutics that are preservative-free, room-temperature-stable, needle-free, and patient-friendly. In most cases, the needle-less administration afforded by the technology requires no medical professional. The GelSite(R) polymer is naturally derived and produced under cGMP with high purity, and requires no organic solvent use for production of the finished product. Eurasian countries are fast-developing economies and are obvious choices for obtaining patent protection."
GelSite(R) polymer is a high-molecular-weight-anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite(R) polymer is water-based and is capable of in-situ gelation, i.e., changing from a solid or liquid into a gel upon contact with body fluids, leading to sustained release of active biomolecules. GelSite(R) polymer has also demonstrated muco-adhesive properties, making it highly suitable for mucosal delivery.
About GelSite(R) and GelVac(TM)
GelSite(R) polymer 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, SA.
The GelVac(TM) system is a nasal powder vaccine delivery platform based on GelSite(R) 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 mucoadhesiveness. Nasal immunization induces both systemic and mucosal immune responses. The GelVac(TM) 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.
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc., is developing its proprietary GelSite(R) 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(TM) 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.
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.
CONTACT: Yawei Ni, Chief Scientific Officer of Carrington Laboratories,
Web site: http://www.carringtonlabs.com/