IRVING, Texas, March 29 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. today announced the Korean Patent Office has issued a Notice of Allowance for Korean Patent Application No. 10-2001-7000869 titled “Pectic Substance As A Growth Factor Stabilizer” relating to the Company’s proprietary GelSite(R) polymer’s ability to bind to and stabilize proteins and peptides. DelSite Biotechnologies, Inc., Carrington’s wholly-owned subsidiary, is developing and commercializing GelSite(R) polymer as a controlled-release drug delivery technology for vaccines and therapeutics.
The patent describes growth factor stabilization and delivery with this polymer. The claims of this patent are broadly applicable to any use of this polymer in pharmaceutical compositions, including protein and peptide growth factors for the purpose of stabilization and delivery.
Growth factors are protein or peptides that stimulate cell division or proliferation and are critical in multiple medical fields, including angiogenesis, wound healing, and immune system maturation. A critical challenge for development of protein/peptide therapeutics is stability and sustained delivery, as the therapeutic agents need to be stable and also be released in a controlled manner to achieve the optimal effect. GelSite(R) polymer is particularly well suited to meet such needs.
“DelSite’s intellectual property estate is broad and strong; we will continue to add patent protection to our proprietary drug delivery technologies. We are pleased to receive the Notice of Allowance patent for this application GelSite(R) polymer,” said Yawei Ni, DelSite senior scientist. “GelSite(R) polymer’s unique abilities to form a gel in situ and function as a stabilizing agent for proteins and peptides as a liquid, gel or powder make it an attractive basis for novel drug delivery systems of therapeutics and vaccines.”
DelSite’s most advanced delivery platform is the GelVac(TM) nasal powder vaccine delivery system based on GelSite(R) polymer. GelVac(TM) is a simple and broad nasal powder vaccine delivery platform suitable for many different classes of vaccine antigens.
DelSite previously announced results of a Phase I clinical trial involving healthy volunteers that demonstrated the GelSite(R) polymer and GelVac(TM) system were 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 the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). Currently, preclinical development is progressing for a GelVac(TM) nasal powder avian influenza (bird flu) vaccine.
About GelSite(R) and GelVac(TM)
GelSite(R) polymer is a naturally high molecular weight anionic polysaccharide that exhibits distinct chemical and functional properties proprietary to the Company. GelSite(R) 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(R) 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 the 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 is mucoadhesive. 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.
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 please 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 and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. Carrington raw materials from Aloe vera L. are the only raw materials from the plant with the DSHEA claim of enhancing the immune system.
Carrington and DelSite technologies are 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, Senior Scientist of DelSite Biotechnologies, Inc.,+1-972-518-1300, or yni@delsite.com
