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Bell, PA – May 22, 2008 – |
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VGX Pharmaceuticals Inc. (VGX) and its affiliate,
VGX Animal Health Inc. (VGXAH), announced today the publication in 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 cancer- related
anemia in companion dogs with spontaneous malignancies (Bodles-Brakhop
et al., Double-blinded, Placebo-controlled Plasmid GHRH Trial for Cancer-associated
Anemia in Dogs, Molecular Therapy, 2008, 16:862-870).
Cachexia and its associated disorders affect up to 5 million people in
the United States alone and represent common complications of cancer,
aging, acquired immunodeficiency syndrome, chronic kidney or heart failure.
Prevalent cancer-associated conditions such as fatigue and poor quality
of life may be induced by the cancer itself or by cancer treatments such
as chemotherapy, with anemia being one of its leading causes in patients.
Similar conditions and symptoms are shared by humans and animals alike.
In the published study, VGX researchers tested the use of a non-viral
DNA molecule, called a plasmid, which encodes for growth hormone-releasing
hormone (GHRH) in 55 companion dogs with spontaneous malignancies and
anemia receiving a cancer-specific treatment in a double-blinded, placebo-controlled
trial. Dogs received a single, low dose of plasmid or placebo, delivered
intramuscularly by the Company’s CELLECTRA® constant
current electroporation device. Plasmid-treated dogs had increases in
all red blood cell count, hemoglobin and hematocrit. 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.
“Publication of this study stresses the potential of VGX technology
to improve human and animal health,” 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 cancer patients.”
VGX Pharmaceuticals is waiting for approval from the Food and Drug Administration
to study the GHRH treatment (VGX-3200) in humans. VGX Animal Health also
plans to develop this product for companion dogs and cats.
Cautionary
Factors That May Affect Future Results - Materials in this
Web site contain information that includes or is based upon forward-looking
statements within the meaning of the Securities Litigation Reform
Act of 1995. Forward-looking statements relate to expectations or
forecasts of future events. You can identify these statements by the
fact that they do not relate strictly to historical or current facts.
They use words such as "anticipate," "estimate,"
"expect," "project," "intend," "plan,"
"believe," and other words and terms of similar meaning
in connection with a discussion of potential future events, circumstances
or future operating or financial performance. In particular, these
include statements relating to future actions, prospective products
or product approvals, future performance or results of current and
anticipated products, sales efforts, expenses, the outcome of contingencies
such as legal proceedings, and financial results. Any or all of our
forward-looking statements here or in other publications may turn
out to be wrong. They can be affected by inaccurate assumptions or
by known or unknown risks and uncertainties. Many such factors will
be important in determining our actual future results. Consequently,
no forward-looking statement can be guaranteed, and forward-looking
statements may be adversely affected by factors, including general
market conditions, competitive product development, product availability,
current and future branded and generic competition, federal and state
regulations and legislation, manufacturing issues, timing of the elimination
of trade buying, patent positions, litigations and investigations.
Our actual results may vary materially, and there are no guarantees
about the performance or valuation of VGX stock. It is also important
to read the disclosure notice contained in many of the individual
VGX documents available on this Web site as many contain important
information on such cautionary factors as of the date of the individual
document. We undertake no obligation to correct or update any forward-looking
statements, whether as a result of new information, future events
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we make on related subjects in our reports. |
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 facilities. The cGMP facilities are
used for VGX’s own product supplies and for contract 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. 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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