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VGX Pharmaceuticals
Announces Initiation of IND-enabling Toxicology Studies
for Candidate DNA Vaccine Products
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Bell, PA – August 15, 2007 – |
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VGX Pharmaceuticals today announced that it 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. VGX is conducting the
studies in combination with its patented CELLECTRA™ electroporation
device and the studies will provide pre-clinical safety data for both
the product candidates as well as the device in a GLP environment.
"We are pleased that our Immune Therapeutics program has entered
the GLP toxicology stage and has allowed us to fully validate our dynamic
vertically integrated product development program for DNA based products,"
stated Dr. J. Joseph Kim, President and CEO of VGX.
All three DNA plasmid-based products have previously demonstrated efficacy
in various animal models. The CELLECTRA™ device delivers DNA plasmids
efficiently via the application of constant-current electroporation pulses.
The device has been tested extensively in research studies in a large
number of different animal models, including non-human primates, establishing
a broad safety, tolerability and efficacy profile.
The current toxicology studies will be completed in early 2008 and Investigational
New Drug Applications (INDs) for the three products are expected to be
filed in the first half of 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 molecules
and biologics product candidates for the treatment of infectious diseases,
cancer and inflammatory diseases. The Company's clinical development programs
include PICTOVIR™ for HIV infection and VGX-410C for chronic HCV infection,
both of which are currently in Phase II clinical trials. In addition, VGX
is planning to initiate Phase I clinical studies for VGX-1027, its lead
compound for inflammatory diseases. VGX's research pipelines include new
generation of DNA vaccines and therapeutics as well as CELLECTRA™,
a proprietary 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.
Company Contact:
Kevin W. Rassas
Senior Vice President
Tel. 267.440.4208
Fax 267.440.4242
E-mail: Rassas@vgxp.com
www.vgxp.com
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