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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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Bell, PA – 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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no forward-looking statement can be guaranteed, and forward-looking
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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 PENNVAX™-B for HIV infection, which is in 2 separate Phase I clinical trials, as well as VGX-1027 for inflammatory diseases, VGX-3100, a DNA therapeutic vaccine for cervical cancer, and the CELLECTRA® electroporation device, all of which are in Phase I clinical trials. In addition, the Company has filed INDs for VGX-3200, a novel DNA therapy that utilizes GHRH for the treatment of cancer cachexia and anemia, and for 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.
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.
Company Contact:
Kevin W. Rassas
Senior Vice President
Tel. 267.440.4208
Fax 267.440.4242
E-mail: Rassas@vgxp.com
www.vgxp.com
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