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VGX
Animal Health announces approval of LifeTide™ SW 5
- World’s First and Only Approved DNA Therapy for Food Animals
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Woodlands, TX – January 9, 2008– |
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VGX Animal Health, Inc. (VGXAH),
a developer of cutting edge technologies for animal health applications,
announced today the approval by the Australian Pesticides and Veterinary
Medicines Authority (APVMA) of LifeTide™ SW 5, the Company’s
leading Growth Hormone Releasing Hormone (GHRH) product for swine therapy.
LifeTide™ SW 5 is an injectable DNA plasmid encoding for porcine
GHRH, and is administered as a once in a lifetime treatment for use in
sows of breeding age to increase the number of piglets weaned. Licensing
studies completed in Australia demonstrated a significant decrease in
perinatal mortality and morbidity, resulting in an increase in sow productivity
and the number of pigs weaned per sow. The complete approval can be viewed
on the APVMA web site (http://services.apvma.gov.au).
The approval by the APVMA opens the way for commercial sale of LifeTide™
SW 5 in Australia. In addition, VGXAH has submitted an application for
approval in New Zealand, and plans to seek approval in several other countries
in South East Asia including The Philippines and Indonesia. The Company
has also initiated studies to support regulatory approval of this technology
in other major markets, including the United States and China.
Douglas R. Kern, D.V.M., M.S., Vice President of Business Development,
stated, “The approval of this ground-breaking technology is a tremendous
accomplishment for the Company and will benefit swine producers in Australia
and eventually worldwide. This important milestone will help VGX Animal
Health develop additional pioneering applications of the GHRH product
platform for other animal species.”
LifeTide™ SW 5 is delivered to the target tissue by direct intramuscular
injection followed by a process called electroporation, which increases
the efficiency of DNA uptake by the targeted cells. In previously published
studies in peered-reviewed journals, the VGXAH research team under the
direction of Dr. Ruxandra Draghia-Akli demonstrated significant beneficial
effects of this technology in pigs and numerous other species. VGX Animal
Health has an exclusive veterinary-use license for the CELLECTRA™
electroporation device from VGX Pharmaceuticals, Inc. (VGXP), its parent
Company. The device will be used for delivery of LifeTide™ SW 5
and other products in development.
Dr. J. Joseph Kim, Chairman of VGX Animal Health, and President and CEO
of VGX Pharmaceuticals, stated, “The APVMA approval is an important
validation of our ability to use cutting edge DNA-based technology to
improve the health, welfare and productivity of the world’s food
and companion animal populations. Furthermore, our work in animals could
be an important stepping stone for developing our technologies for human
medicine.”
VGX Pharmaceuticals plans to file an investigational new drug (IND) application
for the human version of GHRH as a therapy for treating cachexia (wasting
or heavy weight loss) in cancer patients in the first quarter of 2008.
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to consult any further disclosures we make on related subjects in
our reports. |
About VGX Animal Health
VGX Animal Health, Inc. (“VGXAH” or “The Company”)
was formed in 2007 as a majority-owned subsidiary of VGX Pharmaceuticals,
Inc. (VGXP) specializing in animal health therapeutics. VGXAH’s products
and technology were initially developed by ADViSYS Inc, which was founded
in 1997 and acquired by VGX Pharmaceuticals in early 2007. VGXAH’s
lead product, LifeTide™ SW 5, was approved in Australia in January
2008. The product is an injectable plasmid encoding for porcine Growth Hormone
Release Hormone (“GHRH”). In addition, the Company has conducted
extensive pre-clinical trials for other applications of its proprietary
plasmid-based GHRH therapy in both food and companion animals. Treatment
of cancer cachexia, anemia, and improved milk production are just a few
of the many potential applications of this technology in animal health.
VGXAH’s product candidates and technology programs are protected by
the Company's extensive global intellectual property portfolio. More information
about VGXAH can be found at www.vgxah.com.
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecule and
biologic product candidates for the treatment of infectious diseases, cancer,
and inflammatory diseases. The Company's clinical development programs include
PICTOVIR™ for HIV infection, which is in Phase II clinical trials,
and PENNVAX™-B, a DNA vaccine for preventing HIV infection, which
is in Phase I clinical trials. In addition, VGX is planning to initiate
Phase I clinical studies for VGX-1027, its lead compound for inflammatory
diseases. VGX's research pipeline includes a new generation of SynCon™
DNA vaccines and therapeutics as well as the CELLECTRA™ electroporator,
a patented DNA delivery device. The product candidates and technology programs
are protected by the Company's extensive global intellectual property portfolio.
More information about VGX can be found at www.vgxp.com.
Company Contact:
Doug Kern, DVM, MS
Vice President, Business Development
Tel. 281-296-7300
Fax. 281-296-7333
E-mail: dkern@vgxah.com
www.vgxah.com
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