- Streamlines Future Filings Resulting From Collaborations With
Commercial Partners
- Supports Continued Development of Its Nasal Powder Avian Flu Vaccine
Program
IRVING, Texas, Sept. 13 /PRNewswire-FirstCall/ -- Carrington Laboratories,
Inc. (Nasdaq: CARN) today announced that its subsidiary, DelSite
Biotechnologies, Inc., has filed a Drug Master File (DMF) with the U.S. Food
and Drug Administration. The DMF is for the manufacturing of GelSite(R)
polymer and its use in nasal and other mucosal applications, which would
include its use in the Company's GelVac(TM) powder delivery system. GelSite(R)
is the Company's proprietary drug delivery technology that is being developed
to deliver vaccines, protein and peptide drugs. Current priority is a nasal
formulation for flu vaccines.
A DMF submission to the FDA may be used to provide confidential, detailed
information about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of a drug product.
"This is an important milestone in our technical and business development
strategies for our GelVac(TM) nasal delivery technology, which is based on the
GelSite(R) polymer," said Kenneth (Bill) Yates, president of DelSite. "By
filing the DMF, we now can streamline future regulatory filings and this will
be beneficial to collaborators and commercial or governmental partners. The
DMF also supports the continued development of our vaccine program for H5N1
avian influenza (commonly known as bird flu)."
DelSite's DMF outlined information regarding the manufacture and safety of
the GelSite(R) polymer used as a functional pharmaceutical excipient for
incorporation into therapeutic and vaccine products for mucosal delivery.
GelSite(R) polymer is manufactured by Sabila Industrial, a subsidiary of
Carrington located in Costa Rica.
DelSite's most advanced delivery platform is the GelVac(TM) nasal powder
vaccine delivery system. In May 2005, DelSite announced results of a Phase I
clinical trial involving 15 healthy volunteers that demonstrated that
GelVac(TM) was safe and well tolerated and that doses were consistently and
reproducibly delivered to the nasal cavity.
Development of the GelVac(TM) nasal powder vaccine delivery system is
partially supported by an SBIR biodefense grant and a $6 million NIH/NIAID
preclinical development grant for H5N1 avian influenza.
About GelSite(R) and GelVac(TM)
The GelVac(TM) powder delivery system is based on the proprietary
GelSite(R) polymer, a naturally sourced, high molecular weight ionic
polysaccharide that exhibits distinct chemical and functional properties.
GelSite(R) polymer is capable of in situ gelation, i.e., changing from a
liquid or a powder to a gel upon contact with body fluids.
GelSite(R) nasal powder formulations have the potential to be used for the
delivery of vaccine antigens as well as therapeutic agents. GelSite(R) is not
an adjuvant and is a member of a family of plant polysaccharides classified by
the FDA as Generally Regarded as Safe (GRAS).
The GelVac(TM) system is a nasal powder vaccine delivery platform based on
GelSite(R) polymer. Dry powder formulations delivered nasally provide several
potential advantages, including better stability, room temperature storage, no
need for preservatives and no need for needles. Nasal immunization induces
both systemic and mucosal immune responses.
About DelSite
DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington
Laboratories, was established to commercialize its novel polymer drug delivery
technology. Currently, DelSite is focused on developing delivery systems for
vaccines and therapeutic proteins and peptides that could benefit from
improved intranasal, topical and injectable routes of administration. For more
information please visit http://www.delsite.com .
About Carrington
Carrington Laboratories, Inc. is an ISO-certified, research-based
biopharmaceutical and consumer products company currently utilizing naturally-
occurring, complex carbohydrates to manufacture and market medical, consumer
and oral care products used in managing wounds, lesions in the mouth and for
mucositis, radiation dermatitis, the nutraceutical raw materials Manapol(R)
and Hydrapol(TM). Manufacturing operations comply with cGMP standards. More
than 130 patents in 26 countries protect Carrington's technology. Select
products carry the internationally coveted CE mark, recognized by more than
20 countries around the world. For more information, visit
http://www.carringtonlabs.com .
About Sabila Industrial, S.A.
Carrington's bulk pharmaceutical manufacturing facility operates in
Liberia, Costa Rica and is an ISO 9000 company. Sabila Industrial produces the
GelSite(R) polymer for DelSite's drug delivery technology, as well as the
proprietary raw materials Manapol(R) and Hydrapol(TM) powders. It is a
manufacturing facility licensed by the USDA for the raw material used to
produce the biologic Acemannan Immunostimulant(TM) for fibrosarcoma in the
veterinary market, bulk Acemannan Hydrogel(TM) for wound care and SaliCept(TM)
freeze-dried gel for the professional dental markets. With the largest freeze-
drying operation in Latin America and high-speed filling equipment, Sabila
Industrial has become the ideal location to have both bulk and finished
products manufactured for distribution throughout the United States, Latin
America, Asia and Europe. Sabila Industrial is cGMP and Kosher certified for
the manufacturing of Manapol(R) powder.
Certain statements in this release concerning Carrington Laboratories,
Inc. 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 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 and
Exchange Commission, including Form 10-Q filed August 15, 2005.
Carrington(R), Manapol(R), AloeCeuticals(R), Hydrapol(TM), GelSite(R) and
GelVac(TM) are trademarks, registered trademarks or service marks of
Carrington Laboratories, Inc., in the United States and/or other countries.
All other trademarks or service marks contained herein are the properties of
their respective owners.
SOURCE Carrington Laboratories, Inc.
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Related links:
http://www.carringtonlabs.com
http://www.delsite.com
CONTACT:
Carlton E. Turner, CEO of Carrington
Laboratories, Inc., or Kenneth 'Bill' Yates, President of DelSite
Biotechnologies, Inc., +1-972-518-1300
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