IRVING, TX--(Marketwire - January 26, 2009) - DelSite Inc. (OTCBB: DSII) today announced the
termination of manufacturing operations at its Irving, Texas facility.
Continuation of non-manufacturing domestic operations and manufacturing at
its Costa Rican plant is contingent on new funding.
DelSite Biotechnologies, Inc., its wholly-owned subsidiary, received the
approval from the FDA of the Investigational New Drug (IND) application to
initiate a Phase I clinical study of the Company's lead product candidate
GelVac™ nasal powder H5N1 (bird flu) influenza vaccine.
The GelVac™ nasal powder platform brings distinct benefits to the
vaccine products and patients. It is preservative-free, adjuvant-free and
can stabilize vaccines at room temperature for a long period of time. The
vaccine requires no cold chain and allows needle-free administration,
making it particularly well suited for influenza pandemic preparedness, as
well as controlling the seasonal influenza. Besides the pandemic influenza
(H5N1), the GelVac platform is also suitable for other vaccines, including
the seasonal flu.
Once developed, this vaccine system can significantly improve and reduce
the cost of individual vaccines as well as reduce the cost of stockpiling
strategic vaccines. The GelVac™ powder vaccine platform can be used to
stabilize individual antigens as well as vaccines for extended periods of
time at room temperature. By simply being stable at room temperature,
distribution logistical issues are simplified and cost reduced. Vaccine
losses caused by failures in refrigeration systems are eliminated. Markets
underserved because of unreliable cold chain distribution systems would be
opened.
Dr. Yawei Ni, Chief Scientific Officer of DelSite Biotechnologies, said,
"Receiving approval of this IND is a significant milestone in advancing the
DelSite technology that can potentially revolutionize drug and vaccine
delivery. Our development team worked diligently and effectively with the
FDA and satisfied all Agency's requests in a timely manner. We appreciate
the FDA's diligence in reviewing all aspects of the H5N1 antigen, nasal
delivery device used, pilot powder manufacturing process, release
specifications for the finished vaccine and clinical protocol. We believe
as does the FDA in protecting the public and extending as far as humanly
possible the safety profile of all vaccines."
Dr. Ni added, "The GelVac is a very innovative and effective powder
platform; besides deliverable as a nasal powder, GelVac powder vaccines can
be reconstituted and administered using classical needle technology. Using
this route of administration a strong antigen-sparing effect, i.e.,
increasing numbers of vaccine doses, is created by a classical depot
effect. We believe the paradigm shift under way as to how vaccines are to
be stored, shipped and administered will be accelerated by the GelVac
platform."
Mr. Robert Schnitzius, Acting President and CEO of DelSite, commented: "The
Company continues to seek outside funding and partnership for this and
other powder development projects, including the seasonal influenza, human
papillomavirus (HPV) and typhoid vaccines. The survival of the Company and
initiation date of the clinical trial is contingent on when the Company can
raise sufficient funds to continue operations and initiate the trial. A
contract research organization (CRO) has been retained and dosing patient
can begin within one month after securing adequate funding."
The GelVac™ nasal powder is a novel, in-situ gelling powder based on
DelSite's core technology, GelSite® 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: 1) GelVac™ nasal powder for nasal delivery of vaccines and
therapeutics; 2) GelSure™ for injectable delivery of therapeutics; and,
3) 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
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.
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.
