Carrington Laboratories, Inc. (Nasdaq: CARN) today announced that its subsidiary
DelSite Biotechnologies, Inc., has been granted the U.S. Patent No.
7,202,066 titled "Combination of a Growth Factor and a Protease Enzyme" for
an advanced wound healing technology. DelSite Biotechnologies, Inc.,
Carrington's wholly-owned subsidiary, is developing and commercializing
GelSite(R) polymer as a controlled-release drug delivery technology for
protein/peptide therapeutics and vaccine products.
This U.S. patent covers an important discovery for DelSite in the field
of wound healing. Chronic wounds, including pressure ulcers, venous stasis
ulcers, and diabetic foot ulcers, are difficult to heal and occur more
frequently among elderly individuals, usually with decreased immune
functions. Treatment programs are often not optional because in such
wounds, the growth factor and/or protease functions are often abnormal.
Thus, this novel growth factor and protease combination that stimulates
both cell proliferation and cell migration could provide an effective
solution in enhancing the healing of such wounds.
The patent relates to a novel stable combination of KGF and an
extracellular matrix-degrading protease enzyme in which KGF is not degraded
and remains functional. KGF plays an important role in the wound healing
process and stimulates the proliferation of epithelial cells, including the
skin keratinocytes that forms the outmost layer of the skin. On the other
hand, the protease clears the wound debris to facilitate cell migration and
hence wound closure, thus achieving a synergistic effect with KGF.
"The growth factor and protease combination technology covered under
this patent represents a new and novel treatment solution for wounds," said
Dr. Yawei Ni, senior scientist at DelSite Biotechnologies. "Importantly,
DelSite has also developed the delivery technology for this combination
treatment using its GelSite(R) polymer technology. The polymer has been
demonstrated to be highly suited for the topical delivery of therapeutic
agents to the wounds."
About GelVac(TM) and GelSite(R)
DelSite's leading delivery platform, the GelVac(TM) nasal powder
vaccine delivery system, is a simple and broad vaccine delivery platform
suitable for many different classes of vaccine antigens. GelVac(TM) is
currently being evaluated as a delivery system for H5N1 pandemic influenza
vaccine and is partially supported by a NIH/NIAID Challenge Grant.
GelSite(R) polymer is a naturally sourced, high-molecular-weight
anionic polysaccharide that exhibits distinct chemical and functional
properties proprietary to the Company. GelSite(R) is water-based and is
capable of in situ gelation, i.e., changing either a solid or liquid
formulation into a gel upon contact with body fluids that leads to
controlled-release of active biomolecules. 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 polymer is currently manufactured
to cGMP standards at Carrington Laboratories wholly owned subsidiary,
Sabila Industrial, SA.
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, no need for needles and
muco-adhesiveness. Nasal immunization induces both systemic and mucosal
immune responses. The GelVac(TM) delivery system increases antigen nasal
residence time, providing for prolonged contact with the mucosal surface
which may improve immune response for many different classes of antigens.
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