Carrington
Laboratories, Inc. (Nasdaq: CARN) today announced that its wholly-owned
subsidiary DelSite Biotechnologies, Inc. took delivery of several thousand
doses of the H5N1 influenza (bird flu) antigen from a secured source and is
preparing to initiate America's first clinical program of a nasal powder
bird flu vaccine, combining the H5N1 antigen with DelSite's novel
GelVac(TM) dry powder delivery platform.
An IND filing for Phase I human safety study is planned later this year
pending successful results of toxicology studies which are scheduled to
begin within 30 days.
Successful development of a nasal dry powder bird flu vaccine may fill
key needs in national preparedness against an influenza pandemic,
accelerating the swiftness by which people could be inoculated against a
potentially deadly threat. The Carrington-DelSite technology allows for
stockpiling of vaccine supplies and shipment without refrigeration. The dry
powder-based vaccine may also be self-administered without the use of
needles or the need for attending healthcare professionals.
The GelVac(TM) powder contains the unique GelSite(R) polymer, also
developed and manufactured by DelSite. The GelSite(R) polymer enables in
situ gelling of the vaccine powder when introduced into the nasal passages,
the polymer adheres to the mucosal lining and provides prolonged residence
time that, in turn, increases antigen delivery. Other unique features of
the delivery platform include room temperature stability, prolonged shelf
life, and needle-free administration. Because refrigerated transportation
and storage are not required, GelSite(R) technology could greatly enhance
vaccination programs in developing countries where conventional therapies
and preventives are not practical, thus contributing to greater worldwide
pandemic preparedness.
A Phase I safety study of the GelVac(TM) powder delivery system without
antigen was successfully completed, and it serves as the basis for the
upcoming clinical testing of the system with the bird flu antigen.
Dr. Yawei Ni, DelSite's chief scientific officer, stated, "During the
past year we've honed our manufacturing process for the GelVac(TM)
formulation and are now able to produce greater quantities in less time,
with consistent results. We anticipate the toxicity studies with the
antigen will produce the desired results, and are eager to move forward to
the human clinical testing phase. We've worked very diligently over the
last several years to bring this technology to fruition, and it is most
gratifying and exciting to test its capability in a human clinical setting.
I commend DelSite's dedicated scientific staff for all they have done to
bring our technology closer to a proven means which may benefit people
around the world."
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 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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