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VGX
Pharmaceuticals announces the publication of pivotal data from
its LifeTide™ SW 5 studies, which led to the approval in
Australia of the GHRH gene therapy product for pigs
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| The
Woodlands, TX – August 25, 2008– |
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VGX Pharmaceuticals Inc. (VGX)
and its affiliate, VGX Animal Health Inc. (VGXAH), announced today the
publication in the August 19, 2008 edition of Molecular Therapy, the official
journal of the American Society for Gene Therapy (http://www.nature.com/mt/index.html),
of their work related to the Company’s leading Growth Hormone Releasing
Hormone (GHRH) gene therapy product for the treatment of gestating pigs
(Ryan Person et al., Growth Hormone-releasing Hormone Plasmid Treatment
by Electroporation Decreases Offspring Mortality Over Three Pregnancies,
Molecular Therapy, 2008, Epub Aug 19. This work was part of the critical
data submitted to the Australian Pesticides and Veterinary Medicines Authority’s
(APVMA) which led to the approval in January 2008 of VGX Animal Health’s
GHRH product for pigs, LifeTide™ SW 5, the world’s first therapeutic
plasmid delivered by electroporation to be approved for use in food animals
The published study is VGX’s first work on the effects of GHRH on
pigs, and includes the treatment of 997 gestating pigs with a single 5-milligram
GHRH-plasmid delivered by CELLECTRA®, the Company’s
electroporation device. Data on the subsequent 3 litters of these pigs
were collected and indicated no adverse effects to the treatment. The
first litter displayed a 2.9-kilogram increase in carcass weight, 1.0-millimeter
less back-fat, and a 27.0-gram increase in the daily growth
rate compared with controls. In addition, 21.6% more offspring survived.
In the second and third litters, the treated mothers displayed a lower
mortality rate and increased number of offspring. The third litter also
displayed a 1.6-kilogram advantage in carcass weight, 1.0-millimeter less back-fat,
and a 10.0-gram increase in daily growth rate. Furthermore, the litters
had a 19.04% lower post-wean loss rate.
In the March 18, 2008 issue of Molecular Therapy, the ASGT published VGX’s
work related to the Company’s leading Growth Hormone Releasing Hormone
(GHRH) gene therapy technology for 55 companion dogs with spontaneous
malignancies and anemia receiving a cancer-specific treatment in a double-blinded,
placebo-controlled trial delivered intramuscularly by the Company’s
CELLECTRA® constant current electroporation device. Post-hoc
analysis of the GHRH-treated group showed that responder dogs survived
significantly longer than non-responders and controls. In addition, quality
of life, as defined by 10 different parameters, improved dramatically
with treatment including increases in appetite and decreases in complications
of cancer-related therapies, such as diarrhea and vomiting.
“This second ASGT publication further evidences that plasmid GHRH
delivered by electroporation can decrease morbidity and mortality in mammals,”
stated Dr. J. Joseph Kim, President and Chief Executive Officer. “We
are optimistic that our novel GHRH programs will significantly expand
the treatment options for humans.”
VGX Pharmaceuticals is waiting for approval from the Food and Drug Administration
to study the treatment of humans with GHRH (VGX-3200). VGX Animal Health
expects to distribute LifeTide™ SW 5 in Australia later this year
and also plans to further develop GHRH technology for companion dogs and
cats.
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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,
PENNVAX™-B for HIV infection, which is in 2 separate Phase I clinical
trials, and VGX-1027 for inflammatory diseases, which is in Phase I clinical
trials. In addition, the Company has filed INDs for VGX-3100, a DNA therapeutic
vaccine for cervical cancer; VGX-3200, a novel DNA therapy that utilizes
GHRH for the treatment of cancer cachexia and anemia; and VGX-3400, a DNA
preventative vaccine for avian influenza. VGX has established a vertically-integrated
DNA Vaccines and Therapies Platform with extensive capabilities including
SynCon™ DNA-based product candidates, the CELLECTRA®
delivery device, and efficient cGMP plasmid manufacturing. Vertical control
over key aspects of product development has enabled the Company to consistently
develop multiple product candidates, from bench-to-IND filing, within 1
year. 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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