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VGX Pharmaceuticals signs multi-year production agreement with
the United Kingdom Cystic Fibrosis Gene Therapy Consortium
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Bell, PA – May 12, 2008– |
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VGX Pharmaceuticals (VGX) today
announced that the Company has signed a multi-year supply agreement to
provide plasmid DNA to support the ongoing toxicology and clinical trials
of the United Kingdom Cystic Fibrosis Gene Therapy Consortium comprising
over 80 scientists and clinicians in Edinburgh, London and Oxford dedicated
to the search for effective gene therapy to the lungs of those with Cystic
Fibrosis. Under the terms of the agreement, VGX will provide multiple
batches of a CFTR product to support clinical studies planned to run through
2010. If all options are exercised, several hundred grams of plasmid DNA
will be provided, making this agreement one of the largest contracts for
non-viral gene therapy products ever undertaken.
Alan Larsen, Director of Research at the Cystic Fibrosis Trust, said,
"The CF Trust has committed over £30 million to the Consortium's
cutting edge work culminating in a phase II clinical trial planned for
2009, and we are proud to be leading the world in gene therapy research
for Cystic Fibrosis.”
Consortium Lead Investigator, Dr. Deborah Gill, said, “We are delighted
with our relationship with VGX. Our CpG-free product, utilizing technology
developed by Cayla-InvivoGen, presented some unique challenges for large-scale
production, but the Team at VGX used their vast expertise in producing
non-viral products to meet our demanding timelines. Preliminary results
suggest that the materials produced at VGX are of a higher purity than
previous batches leading to better overall performance in pre-clinical
studies."
Dr. J. Joseph Kim, President and Chief Executive Officer, said, “We
are pleased that the UK CF Gene Therapy Consortium has validated our processing
technology. The signing of the ongoing supply agreement indicates the
confidence the Consortium has in our ability and the scalable nature of
our manufacturing process."
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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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