Carrington Laboratories, Inc, a research-based biopharmaceutical and consumer products company, announced the issuance of Chinese Patent No. ZL 02807315.0 entitled "In Situ Gel Formation of Pectins" which relates to the company's proprietary GelSite polymer technology. The patent describes the use of pectin in situ gelling formulations for the delivery and sustained release of physiologically active agents such as drugs and vaccines.
Carlton E. Turner, CEO of DelSite, said, "This patent reflects our desire to protect intellectual properties in all the countries where we believe DelSite's delivery system will provide competitive advantages. DelSite's technology enables production of vaccines or therapeutics that are preservative-free, room temperature-stabile, and remote area-friendly in that no energy-draining cold chain delivery is required. In most cases, the needle-less administration afforded by the technology requires no medical professional. The GelSite polymer is naturally-derived and produced under cGMP with high purity and requires no organic solvent use for production of the finished product. In view of these qualities, China was an obvious choice for obtaining patent protection."
GelSite polymer is a 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 from a solid or liquid into a gel upon contact with body fluids, leading to sustained release of active biomolecules. It also has demonstrated muco-adhesive properties, making it highly suitable for mucosal delivery.
The company's most advanced delivery system based on this polymer is the GelVac nasal powder vaccine delivery system, which is being evaluated as a delivery system for H5 pandemic influenza vaccine and is partially supported by a NIH/NIAID SBIR biodefense grant and a $6 million challenge grant.
In 2005 the Company successfully completed a phase I safety study of the GelVac nasal powder delivery system without antigen and submitted a Drug Master File (DMF) to the FDA for the use of the GelSite polymer in mucosal applications.
To build on a Phase I safety trial on the GelSite polymer in this connection, Turner stated, "The company will file a request for a pre-Investigative New Drug (pre-IND) meeting with the FDA's vaccine division to lay the foundation for a clinical trial of a nasal powder influenza vaccine consisting of the GelVac delivery system in combination with an egg-based influenza antigen. DelSite does not plan to become a manufacturer of drugs or vaccines, but rather a developer of myriad delivery options for the industry."
DelSite Biotechnologies, Inc. is a drug delivery and biotechnology company established to provide the pharmaceutical and biotechnology industries with novel delivery solutions for vaccines and therapeutic agents. DelSite is a wholly owned subsidiary of Carrington Laboratories, Inc. and was formed based on discoveries at Carrington.