ImmuneRegen(r) BioSciences, Inc., Scottsdale, Ariz., a wholly owned
biotechnology product development and licensing subsidiary of IR
BioSciences Holdings, Inc. (OTCBB:IRBO), has commenced a collaboration
with DelSite Biotechnologies, Inc., a wholly owned subsidiary of
Carrington Laboratories (CARN.OB), to develop a new vaccine adjuvant
system that provides both immediate and sustained immunostimulation for
more effective protection against a variety of transmittable pathogens.
With an initial focus on an influenza virus vaccine, the
collaboration will determine if the combination of ImmuneRegen's
vaccine adjuvant compound, Viprovex(r), and DelSite's unique
adjuvant system, based on the polymer GelSite(r), can potentially
augment the ability of vaccine products to produce the enhanced immune
response. Viprovex, a formulation of ImmuneRegen's Homspera(tm),
has previously shown vaccine adjuvant activity in boosting immune
responses to co-administered influenza vaccine. GelSite's drug
delivery technology supports injection and intranasal administration of
vaccines and drugs, and can be engineered for sustained release of
active ingredients over a period of minutes, days or weeks.
Comprehensive animal data indicates that GelSite's sustained
release feature provides adjuvant-like enhancement to vaccines.
"Our work with DelSite supports the development of vaccines
and adjuvants that can be quickly and easily self-administered,"
said Michael Wilhelm, president and chief executive officer of
ImmuneRegen. Noting that pandemic flu is one of the most significant
healthcare risks facing our nation today, he added, "Viprovex has
already shown strength in fighting contagious disease, including two
common influenza strains found in humans, H1N1 and H3N2, as well as the
potentially pandemic H5N1 (avian flu)."
Viprovex, administered intranasally, has demonstrated its
effectiveness as an adjuvant in the treatment of influenza and as an
anti-influenza agent protecting vaccinated animals from a lethal
pandemic influenza challenge. Several reported animal studies include
the following:
* Studies in an accepted model for human respiratory virus
infection, the Cotton Rat, that show the ability of Viprovex to decrease
the symptoms and aftereffects of certain human influenza virus strains;
* Studies of human influenza-infected mice, which showed fewer
virus particles in lungs, as visible by electron microscopy;
* Preliminary data from studies in ferrets using the highly
pathogenic H5N1 influenza A virus (commonly known as "avian
flu") that suggest similar anti-viral effects in this well-accepted
small-animal model of influenza infection; and
* Studies in the Cotton Rat that show Viprovex enhances the
efficacy and safety of Roche's Tamiflu(r), a neuraminidase
inhibitor used to combat influenza which is stockpiled by governments
around the world to treat potential pandemic avian influenza outbreaks.
DelSite's GelSite polymer is designed to provide controlled
release of peptide and protein drugs and vaccines. GelSite's unique
characteristics include its pH and temperature independence from pH or
temperature levels, ability to gel in the presence of live cells and its
property of binding to and stabilizing important proteins. The GelSite
polymer is classified as "generally regarded as safe" (GRAS)
and is used in the formulation of DelSite's GelVac(tm) nasal powder
bird flu vaccine, which is scheduled to be in human testing later this
year.
About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR
BioSciences Holdings, Inc., (OTCBB: IRBO) is a development-stage
biotechnology company focused on the research, development and licensing
of Homspera(tm), an adult stem cell active compound that can regenerate
and strengthen the immune system. To advance its mission, the
Scottsdale, Ariz.-based company has forged numerous study partnerships
with industry and academic leaders, including Anthrogenesis, Lovelace
Respiratory Research Institute, UC Berkeley, HemoGenix and Virion
Laboratories.
For more information, visit http://www.immuneregen.com.
About Carrington Laboratories, Inc.
Carrington Laboratories, Inc. (OTCBB: CARN) 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, whose technology is protected by more than 130
patents in 26 countries, also manufactures and markets consumer products
and manufactures quality products for other companies. Manufacturing
operations comply with cGMP standards, and select products carry the CE
mark, recognized by more than 20 countries around the world.
For more information, visit http://www.carringtonlabs.com.
About DelSite Biotechnologies, Inc.
DelSite Biotechnologies, a wholly owned subsidiary of Carrington
Laboratories, Inc., is an early-stage drug delivery and biotechnology
company with significant expertise and intellectual property related to
the stabilization and delivery of proteins and peptides. DelSite is
developing its proprietary GelSite(r) technology, which is designed to
provide controlled release of peptide and protein-based drugs and
vaccines. In conjunction with its partner Brookwood Pharmaceuticals,
Inc. (formerly Southern Research Institute), DelSite can provide
formulation development, initial stability profiling and toxicology
screening. In addition, DelSite resources are available to provide
initial manufacturing expertise and production of clinical supplies.
For more information, visit http://www.delsite.com.
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