Officials of DelSite
Biotechnologies, Inc., a wholly-owned subsidiary of Carrington
Laboratories, Inc. (Nasdaq: CARN), said the company's novel powder-based
vaccine delivery technology may solve most of the key obstacles that delay
influenza pandemic preparedness which were discussed by experts at the
worldwide "Options for the Control of Influenza VI Conference" held in
Toronto, Canada last week.
Long-standing problems associated with the production, storage and
distribution of vaccines to meet the challenges posed by a pandemic
outbreak of an influenza virus, such as the bird flu (H5N1), were
highlighted in a series of presentations at the conference. The Conference
was supported by the U.S. Center for Disease Control (CDC) and the
International Society for Influenza and other Respiratory Virus Diseases
(ISIRV). More than 1,500 influenza experts from around the world attended
the conference, including government policy makers, pharmaceutical
executives, researchers, physicians, epidemiologists and other
professionals focused on the control of influenza.
The following key needs were cited:
1. The ability to have an adequate stockpile of vaccines. Current vaccines
must be refrigerated during storage and distribution. Despite its cost
and inconvenience, cold storage does not significantly extend the short
shelf life of influenza antigens and vaccines. DelSite's GelVac(TM)
powder vaccine system has been shown to stabilize and preserve an
influenza antigen at room temperature for more than two (2) years
without loss of potency.
2. The capability to implement rapid distribution in the event of a full
pandemic. According to one flu expert, if the next influenza pandemic
is equivalent to the flu pandemic that occurred in 1957 (H2N2 virus),
timing of actions by the U.S. government would be critical. In 1957,
under transportation systems available at the time, it took only six
months for the virus to travel from China to the U.S. With today's
faster transportation systems allowing 1.2 million people to enter the
U.S. each day, it is anticipated the virus would spread much faster.
For containment of disease, a massive and expeditious vaccination
program, along with other measures, would have to be initiated as
quickly as possible.
According to the same expert, about 10 million doses per week for 25
weeks would have to be delivered in order to protect the U.S.
population during a full pandemic. Current cold chain distribution
systems may not be able to respond, but a nasal powder vaccine that can
be shipped at room temperature and be self-administered may be a
solution. DelSite's nasal powder technology meets these criteria and
could add additional value by providing immunological protection to
recipients at the site where viruses normally enter the body: the
respiratory tract.
3. An effective adjuvant to make the vaccine more powerful. One proposed
approach was to have the vaccine in one vial and the adjuvant in
another vial, and then combine the vaccine with the adjuvant at the
site of vaccination. It was suggested that this approach would allow
for better stockpiling of the adjuvant, which would have a longer shelf
life than the vaccine antigen. However, this system may double
distribution logistics and therefore may be less feasible.
DelSite has data indicating that the GelVac(TM) powder formulation
could be shipped as a powder and reconstituted with sterile water just
prior to injection. GelVac(TM) powder formulation also has a strong
immuno-enhancing or adjuvant-like effect when it is injected after
reconstitution through sustained release of the injected antigen. This
effect could provide protection for more people at lower doses without
the need for a separate adjuvant.
4. A way to reduce the number of months required to produce necessary
antigen, if different from stockpile. Currently, chicken eggs are used
in the U.S. for production of vaccine antigens. This egg-based
manufacturing process requires a minimum of six months. The newest
technology available uses a mammalian cell line to produce antigens.
This cell-based technology is more efficient, faster, and eliminates
allergic problems caused by egg proteins. DelSite's GelVac(TM) powder
vaccine technology works with egg- or cell-based antigen. In addition,
the use of a whole virus (whole virion) provides more potent vaccines
than vaccines produced using split or partial parts of the virus; the
GelVac(TM) technology may be used to deliver vaccines made from any of
these methods.
DelSite's GelVac(TM) platform is based on the GelSite(R) polymer, a
negatively-charged linear polymer with a molecular weight greater than
450,000 which is derived from a natural source and is classified as a GRAS
(generally regarded as safe) by the FDA. GelSite(R) is produced in kilogram
quantities under FDA good manufacturing practices for human drugs (cGMP) in
an ISO-certified facility. Each kilogram of the GelSite(R) polymer can be
used to manufacture approximately 5 to 8 million vaccine doses. Plant
material used in the production of GelSite(R) polymer is recognized as
certified organic by the U.S. Department of Agriculture, European Union and
government of Costa Rica.
After the Influenza Conference concluded, Dr. Yawei Ni, chief
scientific officer of DelSite, stated, "Our GelVac(TM) powder vaccine
delivery platform was the only powder system at the conference, and I
believe it can be used to solve or alleviate basic technology problems that
would be created by a worldwide pandemic. We have completed the Phase I
safety study for the powder system and will file an IND with the FDA for a
Phase I clinical study using a H5N1 antigen later this year."
About DelSite
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc., is
developing its proprietary GelSite(R) technology designed to provide
controlled release of peptide and protein-based drugs and vaccines. DelSite
is currently developing a nasal powder vaccine using its GelVac(TM) formula
with the H5N1 avian flu antigen. This work is partially funded by two
grants from NIAID (National Institute of Allergy and Infectious Diseases)
of NIH (National Institute of Health) under the Department of Health and
Human Services.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based,
biopharmaceutical and consumer products company currently utilizing
naturally-occurring complex carbohydrates to manufacture and market
products for mucositis, radiation dermatitis, wound and oral care, as well
as to manufacture and market the nutraceutical raw material Manapol(R) and
cosmetic raw material Hydrapol(TM). Carrington also manufactures and
markets consumer products and manufactures quality products for other
companies. Manufacturing operations comply with cGMP standards.
Carrington's DelSite Biotechnologies subsidiary is developing its
proprietary GelSite(R) technology designed to provide controlled release of
peptide and protein-based drugs. Carrington's technology is protected by
more than 130 patents in 26 countries. Select products carry the CE mark,
recognized by more than 20 countries around the world. For more
information, visit carringtonlabs.
Certain statements in this release concerning Carrington 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, including the Form 10-Q, filed May
15, 2007.
Carrington Laboratories, Inc.
carringtonlabs
View drug information on Carrington patch.
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