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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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Bell, PA – 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.
uglas 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.
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
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fact that they do not relate strictly to historical or current facts.
They use words such as "anticipate," "estimate,"
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include statements relating to future actions, prospective products
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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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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
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or otherwise. You are advised, however, to consult any further disclosures
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, 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.
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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