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Carrington Receives European Patent Protection for Stabilization of Proteins and Peptides

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Carrington Laboratories, Inc. has announced that it has received a European patent which describes composition and method for stabilization and delivery of growth factors and cytokines with the Company's proprietary GelSite® Polymer.

This patent expands the proprietary base of the Company's drug and vaccine delivery technologies.

DelSite Biotechnologies, Inc., Carrington's wholly-owned subsidiary, has completed a Phase I human safety study of the GelVac™ nasal vaccine delivery system and is actively preparing to initiate clinical trials with influenza (flu) antigen.

Stabilization and delivery of proteins and peptides are critical for the therapeutic applications of these agents that are inherently less stable than small molecule drugs.

GelSite® polymer binds to and stabilizes a subset of heparin-binding growth factors and cytokines, including bFGF (basic fibroblast growth factor) and KGF (keratinocyte growth factor).

Along with the unique in-situ gelling function of this polymer, the binding also provides a sustained release mechanism for achieving prolonged and optimal release of a drug, enhancing the therapeutic effect.

GelSite® polymer platform is applicable for a wide range of proteins and peptides through adjusting formulation conditions.

Dr. Yawei Ni, senior scientist, said, "The patent entitled 'Pectic substances as a growth factor stabilizer' is registered in multiple European countries."

"This is a key patent and increases our existing, strong patent position for our GelSite® polymer-based platform."

"This patent helps us to move DelSite forward as a drug delivery company and increases our ability to work with our partners."

Dr. Carlton E. Turner, CEO, stated, "DelSite's injectable sustained release and nasal powder delivery technology for therapeutics and vaccines using naturally derived polymers is the core foundation and strength of the Company."

"DelSite's polymers are produced in our GMP bulk pharmaceutical manufacturing facilities in Costa Rica, and the technology developed by DelSite has some application on Carrington's wound technology."

"Preclinical studies using an animal (pig) wound model have shown that topical application of a KGF formulation with the GelSite® polymer significantly increased wound re-epithelialization or closure of full-thickness excisional wounds, as compared to the KGF formulation in saline only."