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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, 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
an IND for VGX-3200, a novel DNA therapy that utilizes GHRH for the treatment
of cancer cachexia and anemia. VGX has established a vertically-integrated
DNA Vaccines and Therapies Platform with extensive capabilities including
SynCon™ DNA-based product candidates, the patented 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.
Company Contact:
Kevin W. Rassas
Senior Vice President
Tel. 267.440.4208
Fax 267.440.4242
E-mail: Rassas@vgxp.com
www.vgxp.com
About Cystic Fibrosis Trust
The Cystic Fibrosis Trust (www.cftrust.org.uk)
is the UK’s only national charity dealing with all aspects of Cystic
Fibrosis (CF). It funds research to treat and cure CF and aims to ensure
appropriate clinical care and support for people with Cystic Fibrosis.
For further information on the work of the UK CF Gene Therapy Consortium,
please visit www.cfgenetherapy.org.uk.
About Cayla-InvivoGen
Cayla-InvivoGen (www.invivogen.com)
is a biotechnology company developing innovative products based on breakthroughs
in molecular and cell biology. The company clinical development program
includes a phase I non-viral clinical trial in pancreatic cancer (www.invivogen-therapeutics.com).
The new family of plasmids used for this clinical trial is completely
devoid of CpG dinucleotides and has been developed for non-viral gene
therapy application. These CpG-free plasmids are non-immunostimulatory
even at high doses and allow for sustained expression. This technology
and its use are covered under US patent number 7244609 and are distributed
for research purposes by InvivoGen.
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