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VGX Pharmaceuticals adds cGMP plasmid DNA manufacturing capacity
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Bell, PA – October 24, 2007 – |
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VGX Pharmaceuticals, Inc.,
a leading manufacturer of cGMP-grade DNA plasmids, announced today that
it has expanded its manufacturing capacity with the installation and testing
of a new 500-liter scale fermentor in its cGMP manufacturing facility
in The Woodlands, Texas. The new fermentor gives VGX significantly more
flexibility than its current 100-liter production scale.
In addition to manufacturing DNA plasmids for its own product development
purposes, VGX has been offering contract manufacturing services to outside
client organizations with the flexible, state of the art facility used
for research, development, and clinical supply. VGX-manufactured products
have passed rigorous reviews by several international regulatory agencies.
“This upgrade represents the initial phase of enhancing VGX’s
capabilities to manufacture DNA plasmids for clinical and eventually commercial
applications,” said Dr. J. Joseph Kim, President and CEO of VGX.
“We will continue to enhance our manufacturing capabilities and
capacity to meet the increasing demand for our own DNA-based vaccine and
therapy product candidates as well as those of our clients.”
VGX Pharmaceuticals has initiated IND-enabling pre-clinical toxicology
studies for three of its DNA plasmid-based product candidates. The candidates
include vaccines for human papilloma virus for the treatment of cervical
cancer (VGX-3100) and avian influenza (VGX-3400), and a therapeutic based
on human growth hormone releasing hormone (VGX-3200) for cancer-related
cachexia. The Company expects to file Investigational New Drug Applications
(INDs) for all three products by June 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
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 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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