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Proven Technology Platforms
The Company has developed or has access to proven proprietary
technology platforms, including:
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Patented
Plasmid-mediated Growth Hormone Releasing Hormone (GHRH)
technology that has demonstrated significant effects on muscle
development, reproductive performance, metabolism, health
maintenance and immune functions in animals; profound reductions
(30-70%) in disease and death resulting in increased welfare
and productivity.
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Patented Myogenic
Plasmids that are injected into skeletal muscle,
are not integrated into the cell’s genome and are expressed
by muscle cells for long periods of time (for as long as 2
years); powerful “genes in a bottle” approach
with broad applications in metabolic and infectious diseases.
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Patented (CELLECTRA™
constant current electroporator device) that enhances
the effectiveness of the plasmid-based technology resulting
in increased expression at a lower dose and reduced cost of
product delivered; use of the CELLECTRA™ device has
demonstrated increased plasmid uptake and expression by 10
to 1000-fold over plasmid injection alone.
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Patented Manufacturing
Process developed to minimize COG’s to meet
animal health price points and positions the company to expand
quickly into the animal health market.
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Extensive DNA
Vaccine Toolbox and Experience yielding impressive
results in the area of DNA vaccination. |
The Company has experience with FDA, USDA,
and Australian regulatory filings for GHRH products as well as a broad
based interest in utilizing the Company’s plasmid components,
CELLECTRA™ DNA delivery technology, and manufacturing technologies
for animal health applications.
Significant Animal Applications
The Company is currently developing several
animal health applications for which it will seek U.S. and international
regulatory approvals:
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Correction
of anemia associated with radiation and chemotherapy in dogs
being treated for cancer.
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Reduction in disease and
death and improvement in immune functions, general health
and well-being, milk production and feed efficiency in dairy
cows and nursing sows and their offspring.
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Improvement of growth
rates, feed efficiencies and overall health and well-being
in farm animals such as swine, dairy cattle and beef cattle.
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Management of age-related
disorders in companion animals to improve their general health
and overall quality of life.
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DNA vaccine for significant
viral disease in swine. |
The Company also has developed optimized plasmids,
plasmid components and CELLECTRA™ electroporation device, that
has been used for animal DNA vaccines, administration of therapeutic
peptides, and plasmid based RNAi therapies for important human viral
diseases. The Company has access to a GMP plasmid manufacturing facility
and currently offers contract plasmid manufacturing for veterinary
clinical trials.
Key Intellectual Property and Regulatory Milestones to Date
The Company has made significant progress in
protecting its intellectual property. For the first time in history,
the creation and defense of large and profitable animal health markets
based on intellectual property are possible. As Intellectual property
is secured, the Company is pursuing several regulatory approvals to
commercialize its technologies. Milestones in establishing its market
position include:
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Filing significant
amount of IP to date around its technology platforms encompassing
40 potential patent families and approximately 200 individual
patents.
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Recently merged with VGX
Pharmaceuticals to broaden IP portfolio and begin regulatory
efforts on animal health GHRH and DNA vaccine applications.
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Applied for and received
international permits to conduct proof-of-concept and licensing
studies in Australia.
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Final stages of product
registration and approval with Australian regulatory agency
for commercial swine application of technology. Expect to
receive final regulatory approval for commercial application
in late 2007. |
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Completed preliminary
work with GHRH therapy in companion animals. Ready to re-launch
pivotal clinical trial with the FDA for dogs with solid tumors
and anemia, as well as dogs and cats with renal insufficiency. |
Anticipated Future Key Regulatory
and Commercialization Milestones
The
Company has achieved key milestones in the commercialization of its
technologies and in the utilization of its investment in its state-of-the-art
manufacturing facilities, including:
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2007 |
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Ramp up to Australian/Indonesian
market swine product launch.
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Approach VC and/or Big
Pharma to secure partnership for development of animal health
business.
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2008 |
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Launch commercial GHRH
treatment of swine in Australia and Indonesia.
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File porcine
INAD with FDA for U.S. GHRH applications.
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Secure licensing partnership(s)
and/or initiate regulatory discussions with US and international
regulatory agencies for multiple swine, dairy and beef applications.
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Secure Licensing partner
for companion animal applications.
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