SOURCE: DelSite, Inc.

November 13, 2008 12:52 ET

DelSite Presents Nasal Powder and Synthetic Typhoid Vaccine Technologies at the 2nd Vaccines Asia Conference

GelVac™ Nasal Powder Platform for Needle-Free and Cold Chain-Free Vaccine Delivery

Synthetic Typhoid Fever Vaccine -- Safer and More Economical Approach Against a Major Infectious Disease That Causes 500,000 to 600,000 Deaths per Year Worldwide

Significant Advantages Over Current Vaccine Technologies

IRVING, TX--(Marketwire - November 13, 2008) - DelSite Inc., (OTCBB: DSII) today announced Dr. Yawei Ni, chief scientific officer, of its wholly-owned subsidiary, DelSite Biotechnologies, Inc., presented its innovative GelVac™ nasal powder platform for vaccine delivery and the synthetic typhoid vaccine at the 2nd Vaccines Asia Conference held November 10-13, 2008, in Beijing, China.

Dr. Ni's oral presentations highlighted the significant advantages of the GelVac™ nasal powder platform technology for vaccine delivery and the synthetic typhoid vaccine over the current vaccine technologies and provided an update on the development status of its lead product candidate GelVac™ nasal powder H5N1 (bird flu) influenza vaccine.

The GelVac™ nasal powder is a highly innovative, in-situ gelling (gels on contact with body fluids) powder delivery platform. It is a simple and broad platform suitable for many different classes of vaccines and therapeutics, providing room temperature stability and needle-free administration. DelSite has completed a series of development activities, including pre-IND meetings with the FDA, animal toxicology studies, and a phase I safety study of GelVac™ nasal powder without an antigen. An IND for a nasal powder H5N1 influenza vaccine based on GelVac™ powder platform has been filed with the FDA. The advantages afforded by the GelVac™ nasal powder technology, including room temperature stability, cold chain-free distribution and needle-free administration, make this vaccine particularly well suited for influenza pandemic preparedness as well as epidemic control. The development effort for this vaccine is partially supported by a NIH/NIAID Challenge Grant.

Typhoid fever is caused by Salmonella typhi and is a major neglected infectious disease. Worldwide Salmonella typhi causes 16 to 33 million infections and 500 to 600 thousand deaths per year. Currently marketed Vi polysaccharide vaccines are made by the costly and hazardous fermentation of Salmonella typhi bacteria and extensive purification process. DelSite's proprietary synthetic vaccine is based on its novel polysaccharide technology and is produced with a simple chemical process with a great yield (~100%) that bypasses expensive bacterial fermentation and purification process. It is also safer, as it eliminates the possible endotoxin contamination lipopolysaccharide (LPS) that may occur with vaccines produced from bacteria. This new synthetic vaccine approach may be qualified for the Priority Review Voucher program recently established by the FDA.

Dr. Carlton Turner, CEO of DelSite, Inc., commented, "DelSite Biotechnologies was established to be an innovative drug and vaccine delivery technology company. We believe this has been accomplished. DelSite Biotechnologies has developed a significant repertoire of technologies and product candidates based on its core technology. The nasal powder and synthetic typhoid fever vaccines are both first in their respective classes. DelSite is actively working with several biotech and large pharma companies to evaluate and develop products based on its delivery technologies. We believe our protected technologies will greatly improve the production, delivery and administration of vaccines and therapeutics throughout the world, and bring significant values to the worldwide market."

Turner continued, "According to the Pharmaceutical Research and Manufacturers of America (PhRMA), 146 vaccines are in development by biotech and large pharma companies. However, all of them, except for eight, still utilize the classical vaccine delivery system using needles. Of the other eight, three are transdermal and five intranasal (two of which are powder). I believe DelSite Biotechnologies is driving the paradigm shift in vaccines away from the need for needles, cold chain distribution, preservatives, adjuvants and limited distribution toward a user-friendly, worldwide distribution system with its nasal powder delivery platform."

DelSite's core technology is the GelSite® polymer, a chemically and functionally distinct polygalacturonic acid (sodium salt) produced under cGMP to a purity of > 99%. It is uniquely capable of gelling in-situ at the administration site upon contact with body fluids at low polymer concentrations providing a sustained release mechanism of the active component. 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.

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