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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.”
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
forecasts of future events. You can identify these statements by the
fact that they do not relate strictly to historical or current facts.
They use words such as "anticipate," "estimate,"
"expect," "project," "intend," "plan,"
"believe," and other words and terms of similar meaning
in connection with a discussion of potential future events, circumstances
or future operating or financial performance. In particular, these
include statements relating to future actions, prospective products
or product approvals, future performance or results of current and
anticipated products, sales efforts, expenses, the outcome of contingencies
such as legal proceedings, and financial results. Any or all of our
forward-looking statements here or in other publications may turn
out to be wrong. They can be affected by inaccurate assumptions or
by known or unknown risks and uncertainties. Many such factors will
be important in determining our actual future results. Consequently,
no forward-looking statement can be guaranteed, and forward-looking
statements may be adversely affected by factors, including general
market conditions, competitive product development, product availability,
current and future branded and generic competition, federal and state
regulations and legislation, manufacturing issues, timing of the elimination
of trade buying, patent positions, litigations and investigations.
Our actual results may vary materially, and there are no guarantees
about the performance or valuation of VGX stock. It is also important
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
document. We undertake no obligation to correct or update any forward-looking
statements, whether as a result of new information, future events
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 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 VGX Contract Manufacturing Services
VGX offers cGMP contract manufacturing
services with a flexible, purpose-built facility used for research, development,
and clinical supply of plasmid DNA based products. In addition, the VGX
manufacturing facility incorporates a cost-effective process that has
been scaled to meet clinical needs and is easily transferable to alternate
locations. The VGX manufacturing staff has extensive experience in the
areas of Process Development, Quality Control, Quality Assurance, and
Validation of plasmid-based biopharmaceuticals. The manufacturing facility
has passed rigorous reviews by global regulatory agencies. More information
about VGX Contract Manufacturing Services can be found at http://www.vgxp.com/manufacturing.html
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 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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