SOURCE: DelSite, Inc.

November 12, 2008 08:29 ET

DelSite Patent for GelSite® Polymer Technology Issued

Protects GelSite® Polymer Core Technology; Manufactured Under cGMP at Kilogram Scale; Delivery Solutions for Therapeutics and Vaccines and Other Medical Applications; Drug Master File Filed With the FDA

IRVING, TX--(Marketwire - November 12, 2008) - DelSite, Inc. (OTCBB: DSII) today announced that the United States Patent and Trademark Office has granted a Notice of Issuance of patent application No. 10/422,867, titled "High Molecular Weight, Low Methoxyl Pectins and their Production and Uses," relating to the Company's proprietary GelSite® polymer technology. DelSite Biotechnologies, Inc., a subsidiary of DelSite, Inc., is developing and commercializing GelSite® polymer as a controlled-release drug delivery technology for therapeutics and vaccine products.

The issued patent covers the basic composition of the novel plant pectins or polygalacturonic acids (GelSite® polymer), based on its distinct properties that are not found with related natural or synthetic polymers. The claims of this patent are broadly applicable to any use of GelSite® polymer and extend to use in pharmaceutical compositions including proteins, peptides, vaccine antigens and other pharmacological substances.

DelSite has successfully developed the manufacturing process for GelSite® polymer. It is now manufactured under cGMP at a kilogram scale with a purity of > 99%. A Drug Master File for this polymer was filed with the FDA in 2005 and is being updated regularly, allowing streamlined regulatory review for any medical applications.

GelSite® polymer has unique functional properties including in situ gelation and the ability to stabilize proteins; these properties make it an attractive basis for novel drug delivery systems. Based on this core technology, DelSite has developed three delivery platform technologies: GelVac™ nasal powder for nasal delivery of vaccines and therapeutics, GelSure™ for injectable delivery of therapeutics, and GPDA™ depot adjuvant for injectable delivery of vaccines. DelSite is actively working with several biotech and large pharma companies to evaluate and develop products based on these delivery technologies.

"DelSite continues to build a strong intellectual property estate around our proprietary drug and vaccine delivery technologies worldwide, and we are pleased to receive the U.S. patent for GelSite® polymer," said Dr. Yawei Ni, chief scientific officer at DelSite Biotechnologies. "This is a very significant key patent that protects the composition of GelSite® polymer and its uses for drug and vaccine delivery, as well as other medical applications."

Dr. Carlton Turner, CEO of DelSite, Inc., added, "Together with cGMP manufacturing and regulatory filing of the Master File, a strong patent portfolio has been built that forms the foundation for a wide range of commercial opportunities for this novel technology."

"We are actively exploring ways to commercialize our technology and monetize the intrinsic value embedded in our platforms developed around the GelSite® polymer. Evaluations are under way in many areas involving all three platforms, the antigen platform (GPDA™ depot) for select vaccines, GelVac™ powder for nasal delivery of influenza and other antigens, and GelSure™ for delivery of injectable proteins or implantable products containing proteins. As we expand our patent coverage, it enhances not only the value of our internal development projects, but also those being evaluated by external organizations under agreements with us."

Turner continued, "I believe our patent-protected technology is capable of solving many costly and access-limiting problems associated with the production, delivery and administration of vaccines and therapeutics throughout the world. Our GelVac™ nasal powder platform can eliminate the costly cold chain delivery system and the need for preservatives or adjuvants. It enables products that do not demand modern medical facilities for their administration, or extensive training of care givers."

The GelVac™ nasal powder is DelSite's leading delivery platform. It is a simple and broad delivery platform suitable for many different classes of vaccines and therapeutics, providing room temperature stability and needle-free administration. DelSite has been developing a nasal powder H5N1 influenza vaccine based on the GelVac™ powder platform. An IND for this vaccine candidate has been filed with the FDA. DelSite anticipates initiation of the proposed Phase I clinical study in the near future. The development of effort for this vaccine is partially supported by a NIH/NIAID Challenge Grant.

About DelSite Biotechnologies, Inc.

DelSite Biotechnologies, Inc. a wholly-owned subsidiary of DelSite, Inc., is dedicated to the delivery and stabilization of proteins and peptides for therapeutics and vaccines. The GelVac™ powder platform is for nasal delivery of vaccines and therapeutics. GelSure™ has been developed for liquid delivery and GPDA™ is for adjuvant use. Core platform technology is based on a natural polysaccharide, GelSite® polymer.

About DelSite, Inc.

DelSite, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company with a core technology based on naturally-occurring complex carbohydrates. DelSite also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. DelSite is developing its proprietary GelSite® technology designed to provide controlled release of peptide and protein-based drugs. Its technology is protected by more than 130 patents in 26 countries. For more information, visit www.delsite.com.

Certain statements in this release concerning DelSite 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 Information

  • For Information Contact:
    Carlton E. Turner
    Chief Executive Officer
    (972) 518-1300