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VGX Pharmaceuticals announces the IND filing of VGX-3200, a novel
DNA therapy that utilizes GHRH for the treatment of cancer cachexia
and anemia
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Bell, PA – February 8, 2008– |
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VGX Pharmaceuticals today announced
it has submitted an investigational new drug (IND) application to the
U.S. Food and Drug Administration (FDA) for Phase I clinical studies of
VGX-3200 in late stage cancer patients. VGX-3200 is an injectable DNA
plasmid-based therapeutic that expresses human Growth Hormone Releasing
Hormone (GHRH) protein. VGX’s innovative DNA delivery technology
allows GHRH to be naturally produced and maintained under endogenous physiologic
feedback regulation. Treatment for cancer-related cachexia and anemia
is the first target for VGX-3200. Additionally, the Company is developing
the GHRH technology for a number of other indications including age-related
disorders.
Studies in different animal models and humans have shown that GHRH has
both direct and indirect functions in development, protein metabolism,
and maintenance of hematological and immune status under physiological
and pathological conditions. The proposed human studies with plasmid-delivered
GHRH follow successful studies in dogs with cancer. Administration of
GHRH plasmid with VGX’s CELLECTRA™ electroporation device
was shown to increase IGF-I levels, ameliorate cachexia, improve anemia,
prolong survival, and improve quality of life in dogs with cancer.
“VGX-3200 has the potential to provide novel treatment options for
patients suffering from several devastating conditions," stated Dr.
J. Joseph Kim, President and Chief Executive Officer. “VGX will
continue to leverage our prolific product development platform to bring
several product candidates to clinical evaluation. We plan to file two
additional INDs for our SynCon™ product candidates during the first
two quarters of 2008: VGX-3100, a therapeutic vaccine for the treatment
of cervical cancer and VGX-3400, a pandemic avian flu vaccine.”
Cachexia, an illness affecting up to 5 million people in the United States
alone, and its associated disorders are common complications of cancer,
aging, acquired immunodeficiency syndrome, chronic kidney or heart failure.
Cachexia is one of the most devastating symptoms of cancer and typically
results in drastic (greater than 10% of total body weight) weight loss.
This complication, which is suffered by up to 75% of cancer patients,
can often be fatal before death due to the actual disease. Currently,
there is no viable treatment for cachexia.
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Web site contain information that includes or is based upon forward-looking
statements within the meaning of the Securities Litigation Reform
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They use words such as "anticipate," "estimate,"
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forward-looking statements here or in other publications may turn
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no forward-looking statement can be guaranteed, and forward-looking
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Our actual results may vary materially, and there are no guarantees
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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 PICTOVIR™ for HIV infection, which is in Phase
II clinical trials, and PENNVAX™-B, a DNA vaccine for HIV infection,
which is in 2 separate Phase I clinical trials. The Company’s lead
compound for inflammatory diseases, VGX-1027, is also in Phase I clinical
trials. 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.
About VGXI Inc.
VGXI Inc. is a leading manufacturer of DNA plasmids, and its cGMP and
non-cGMP products have passed rigorous reviews by several international
regulatory agencies. VGXI offers a wide variety of contract manufacturing
services to outside client organizations. The Company’s cGMP manufacturing
facility in The Woodlands, Texas is a flexible, purpose-built facility
used for research, development, and clinical supply. The site includes
500-liter and 100-liter fermentors and incorporates a cost-effective process.
VGX International also has initiated a project to build and operate a
3000-liter scale cGMP, DNA plasmid manufacturing facility in Asia.
Company Contact:
Henry Hebel
Vice President, Manufacturing and Operations
Tel. 281.296.7300
Fax 281.296.7333
E-mail: hhebel@vgxii.com
www.vgxii.com
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