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VGX Pharmaceuticals Announces Initiation of VGX-cGMP Manufactured
Plasmid Products in Clinical Use by Partners
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Bell, PA – February 5, 2008– |
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VGX Pharmaceuticals today announced
that the DNA plasmid-based product manufactured by VGX on behalf of Nucleonics,
Inc. has entered Phase I human clinical trials in the United States and
Europe for the treatment of chronic Hepatitis B virus (HBV) infection.
The Nucleonics’ HBV clinical candidate (NUC B1000) is an expressed
interfering RNA (eiRNA) based product, consisting of a plasmid DNA construct
that encodes four short interfering RNA (siRNA) molecules, each under
the control of an RNA polymerase III promoter. Each of the four siRNAs
targets a different segment of the HBV genome, collectively leading to
the potential destruction or elimination of all RNA species produced by
HBV within an infected cell. The result is a potent antiviral effect designed
for efficacy against all HBV genotypes, including drug resistant strains.
“VGX’s extensive experience in DNA plasmid manufacturing as
well as their responsiveness as an organization to meet our specific needs
have been very helpful,” said Dr. C. Satishchandran, Ph.D., Chief
Operating Officer and Executive Vice President of Nucleonics. “The
level of cooperation by the manufacturing and quality teams at VGX made
it seem like they were an extension of our own internal teams."
A second VGX cGMP manufactured plasmid product is a component of a real-time
PCR diagnostic kit for fungal infections being developed by Myconostica,
ltd. The FXG™: Resp (Asp+) kit has been developed by Myconostica
as an aid for the diagnosis of Aspergillus and Pneumocystis fungi, the
common causative agents of life-threatening respiratory infections. Over
10 million people are at risk of life threatening respiratory fungal infections
in Europe and North America each year and current methods for fungal diagnostics
are inherently slow and imprecise.
Commenting on the showcasing of Myconostica’s diagnostic product,
Professor David Denning, Research Director of Myconostica said, “There
is a great need for precise diagnostics with a rapid turn around time
for the diagnosis of disease-causing fungi in respiratory and other clinically
relevant tissues and body fluids. VGX’s extensive DNA manufacturing
experience and cGMP capabilities were helpful to us in establishing critical
standards and controls for our FXG™: Resp (Asp+) molecular test
kit.”
“We are very pleased to see the translation of these exciting product
candidates progress into human trials,” said Dr. J. Joseph Kim,
CEO and President of VGX Pharmaceuticals. “The Nucleonics trial
marks the first time that a targeted RNAi therapeutic has been systemically
delivered to patients, and VGX is pleased to have been selected to manufacture
the product under cGMP to mark this important milestone in the RNAi area.
The Myconostica product represents an important aid soon to be available
to clinicians in the area of fungal diagnostics. Together, the products
highlight the breadth of VGX expertise in tackling complex and diverse
projects and adaptability to meet client specific requirements across
the broad pharma-diagnostics spectrum.”
He continued, “VGX operates a state-of-the-art cGMP plasmid manufacturing
facility to produce products that are in development internally at VGX
as well as for partners under contract. We value the external vote of
confidence in our manufacturing capabilities brought about through our
partnerships. Indeed, VGX carefully selects its manufacturing clients
based on their technical excellence and market potential of the products.”
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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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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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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 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
About Nucleonics, Inc.
Nucleonics, founded in January 2001, is an emerging biotechnology company
focused on the development of novel RNA interference-based therapeutics
for viral and other diseases. Privately owned, Nucleonics is headquartered
in Horsham, Pennsylvania. For more information on the company, please
visit the Nucleonics website at http://www.nucleonicsinc.com.
About Myconostica, Ltd.
Myconostica is a leader in molecular diagnostic tests and services for
life-threatening fungal infections. The company’s FXG family of
diagnostic tests will accurately, specifically and reliably identify fungal
causes of infection in less than half a day to enable doctors and clinicians
to diagnose and treat
life-threatening fungal infections, thereby reducing patient mortality
rate, hospital residence time and healthcare costs.
The Company was founded by David Denning, Professor of Medicine and Medical
Mycology, University Hospital South Manchester. Today, it employs a team
of research, product development and marketing professionals and managers
who are developing a rich pipeline of innovative products and services
for the diagnosis of life-threatening fungal diseases will be launched
over the next years.
For further information on Myconostica, Ltd., please visit http://www.myconostica.co.uk/.
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