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Bell, PA – December 27, 2007 – |
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VGX Pharmaceuticals announced today the successful
completion of its first study to assess the tolerability of VGX’s
patented CELLECTRA™ electroporation device in humans. Ten healthy
adult volunteers were treated with the CELLECTRA™ device and were
asked to report the level of discomfort they experienced immediately after
electroporation and at various times thereafter. The procedure was generally
well tolerated. On average, the patients reported a moderate level of
discomfort during the procedure. However, the discomfort was short-lived,
with comfort levels approaching baseline levels within 30 minutes following
the procedure. Other complaints were mild and did not require any treatment.
Numerous preclinical efficacy studies have shown that delivery of VGX’s
DNA products with the CELLECTRA™ device resulted in therapeutic
and protective immune responses that are unachievable by other treatment
or vaccine methods.
“The completion of this Human Tolerability Study is a major milestone
for VGX Pharmaceuticals,” stated Dr. J. Joseph Kim, President and
Chief Executive Officer. “This is just the first step in our aggressive
strategy to develop a potent and prolific DNA-based drug and vaccine development
platform.”
Over the years, VGX Pharmaceuticals has established itself as a leading
developer and manufacturer of DNA plasmid-based vaccines and therapies.
The Company has built extensive, vertically-integrated capabilities including
SynCon™ DNA-based product candidates, the CELLECTRA™ delivery
device, and efficient cGMP manufacturing facilities for its own product
supplies and for contract manufacturing.
PENNVAX™-B vaccine, the first of VGX Pharmaceuticals' SynCon™
DNA vaccine candidates, is already in Phase I clinical trials as a preventative
vaccine for HIV infection. VGX Pharmaceuticals plans to file three additional
INDs for its SynCon™ DNA vaccine candidates during the first two
quarters of 2008: VGX-3100, a therapeutic vaccine for the treatment for
cervical cancer; VGX-3200, a therapeutic based on human growth hormone
releasing hormone (GHRH) for cancer-related cachexia (wasting or heavy
weight loss); and VGX-3400, a pandemic avian flu vaccine. All of these
vaccines are delivered by the CELLECTRA™ device.
VGX Pharmaceuticals operates a 500-liter scale cGMP DNA plasmid manufacturing
facility in The Woodlands, Texas. In addition, the Company has initiated
a project to build and operate a 3000-liter cGMP manufacturing facility
in Korea with its affiliate, VGX International.
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 preventing HIV infection, which
is in Phase I 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 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.
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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