* First Nasal Powder Vaccine Against Bird Flu * Moving to Clinical Development Stage * Platform Suitable for Pandemic Preparedness and Epidemic Control * Significant Advantages Over Current Vaccine Technologies
IRVING, Texas, Aug. 20, 2008 (GLOBE NEWSWIRE) -- DelSite Inc., (OTCBB:DSII) today announced DelSite Biotechnologies, Inc., its wholly-owned subsidiary, filed an Investigational New Drug (IND) application with the FDA for its lead product candidate GelVac(tm) nasal powder H5N1 influenza vaccine.
The IND application is for a Phase I safety and immunogenicity study of this influenza vaccine in healthy volunteers. The filing initiates a 30-day review period by the FDA. The FDA may request additional information and clarification before the clinical study can begin.
Leading up to this IND application, DelSite completed a series of development milestones, including animal toxicology studies, a Phase I safety study of GelVac(tm) nasal powder without an antigen and pilot cGMP manufacturing of the vaccine product suitable for clinical studies.
The GelVac(tm) nasal powder platform combines the advantages of nasal immunization and powder formulation and brings distinct benefits to the vaccine products and patients. These include room temperature stability, cold chain-free distribution and needle-free administration, making this vaccine particularly well-suited for influenza pandemic preparedness, as well as epidemic control.
Dr. Yawi Ni, chief scientific officer of DelSite Biotechnologies, said, "Filing this IND marks a major milestone in development of DelSite's drug and vaccine delivery technologies. It also represents the significant growth of our development team working from the basic research to pilot cGMP manufacturing and regulatory filing. This also enhances DelSite's capability of drug/vaccine delivery technology services by enabling a streamlined path to clinical studies for development of product candidates that DelSite may provide to potential partners. We believe that GelVac(tm) nasal powder represents a significant technological improvement in vaccine technologies and can bring significant advantages to the vaccine products."
Dr. Carlton Turner, CEO of DelSite, commented, "I believe the vaccine industry is undergoing a transition to a safer, more user friendly delivery platform. The needle platform system, which has served mankind well and saved many lives, has also created controversy over the perceived or real effects caused by heavy metal preservatives and adjuvants. Additionally, the requirements for shipping vaccines cold or frozen, as well as maintaining those conditions until administering, have added expense and limited distribution, particularly to those most needy in the developing areas of the world."
Turner added, "I believe the GelVac(tm) platform facilitates the beginning of a true paradigm shift away from needles for the delivery of vaccines. GelVac(tm) is a powder formula that can be self-administered nasally using a unit dose device. The nasal powder formulation needs no preservatives, no adjuvants, no needles and cold storage is not required. Since one kilogram of the GelSite(r) polymer in the GelVac(tm) formula can make more than 8 million doses, the cost per vaccine dose can be significantly reduced. DelSite has one influenza vaccine that has been stable for over 3 years at room temperature. Naturally, we are excited about the possibilities of our platform providing stable vaccines that can enhance distribution, open up new markets and help prevent human suffering."
The GelVac(tm) nasal powder is a novel, in-situ gelling powder based on DelSite's core technology, GelSite(r) polymer, which is a high molecular weight ionic polysaccharide manufactured under cGMP at kilogram scales. Based on this core technology, DelSite has developed three delivery platforms: GelVac(tm) nasal powder for nasal delivery of vaccines and therapeutics, GelSure(tm) for injectable delivery of therapeutics and GPDA(tm) 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(tm) powder platform is for nasal delivery of vaccines and therapeutics. GelSure(tm) has been developed for liquid delivery and GPDA(tm) is for adjuvant use. Core platform technology is based on a natural polysaccharide, GelSite(r) 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(r) 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.
DelSite Inc. Carlton E. Turner, Chief Executive Officer (972) 518-1300