Carrington
Laboratories, Inc. (Nasdaq: CARN) today announced its wholly-owned
subsidiary, DelSite Biotechnologies, Inc., has secured a source of
influenza antigen for a planned Phase I Clinical Trial of a novel nasal
powder influenza vaccine based on its GelVac(TM) dry powder technology. The
GelVac(TM) powder contains the unique and enabling in situ gelling
GelSite(R) polymer that is manufactured by DelSite. This vaccine provides
distinct potential advantages that could meet the critical needs for
pandemic preparedness and epidemic control, including room temperature
stability, prolonged shelf life, distribution without refrigeration, and
needle-free administration.
A Pre-IND meeting with the FDA on this nasal powder vaccine was
completed in November of 2006. Toxicology study protocols relevant to this
vaccine are being reviewed at the FDA. Pending successful toxicological
studies, this will be the first influenza nasal powder vaccine to be used
in a human clinical trial. The GelVac(TM) system requires no organic
solvent in the manufacturing process, uses no preservatives, and does not
require refrigeration. It also gels in situ and is mucoadhesive, providing
prolonged nasal residence time and thus increasing antigen delivery.
Additionally both systemic and mucosal immunity are induced with nasal
immunization.
Dr. Yawei Ni, senior scientist at DelSite, stated, "The effectiveness
of GelVac(TM) nasal powder influenza vaccine has been well demonstrated in
our preclinical studies. Previously, we completed a Phase I human safety
study on GelVac(TM) powder system (without antigen) with results that form
the basis for this upcoming Phase I study. In addition, GelVac(TM) powder
with influenza antigens has been stable at ambient room temperature for
over two years, which has positive implication for future stockpiling of
vaccines for pandemic use."
Carlton E. Turner, CEO of Carrington said, "The acquisition of a GLP
and cGMP antigen relieves us of the expense of producing an antigen using
our viral and cell banks. Thus, we can invest these funds toward the needs
for the Phase I trial. In March of 2006, briefings were held with key
members of Congress, relevant Congressional Hill Committee staffers, and
policy makers at HHS on DelSite's nasal powder vaccine technology. DelSite
was asked if it were possible, for national preparedness, to develop the
dry powder nasal technology faster than the milestones required by NIH
grants supporting our platform and pandemic bird flu (H5N1) influenza
vaccine program. I accepted the challenge to use Carrington funds and
accelerate our nasal delivery vaccine program. The acquisition of this
antigen furthers our ability to meet my commitment to members of Congress,
their Committees and policy makers. Nothing is definite until clinical
results are analyzed, but based on the strength of our technologies, I
believe our shareholders will get great value out of this program. And our
nation will have another tool in its arsenal to vaccinate and protect our
citizens in pandemic or routine seasonal influenza needs."
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 and vaccines. 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-K, filed April
2, 2007.
Carrington Laboratories, Inc.
carringtonlabs
View drug information on Carrington patch.
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