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Bell, PA – December 13, 2007 – |
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VGX Pharmaceuticals announced today that it has completed
the multi-site, multi-dose, and double-blind Phase II study for assessing
the safety and antiviral effects of VGX-410C, its lead product candidate
for treating HCV infection. The data showed that VGX-410C did not meet
the efficacy endpoint of the study.
Although, VGX-410C was safe and well tolerated in patients in all three
daily doses--150, 300, and 600 mg, one out of six patients in the 600
mg dose group had HCV viral load reduction of ten times or more (one log
reduction).
Based on the study data and other on-going product development opportunities
for VGX, the Company has decided to suspend any further development of
VGX-410C for HCV infection and concentrate its resources for a further
development of more promising drug and vaccine candidates for infectious
disease, including HIV and cancer.
“VGX Pharmaceuticals has several product candidates in the pipeline
with significant market potentials,” said Dr. J. Joseph Kim, CEO
and President. “We will focus our resources on those programs that
can create the greatest value for our Company and our shareholders.”
Most advanced programs include novel therapies and vaccines for HIV infection:
PICTOVIR™ in Phase II clinical trials and PENNVAX-B™, a DNA
vaccine, in Phase I clinical trials. PICTOVIR™ was filed with the
FDA for a combination therapy as a part of its Phase II clinical trials,
which is planned to be completed in 2008.
In addition, VGX has recently filed an Investigational New Drug Application
(IND) with the FDA for VGX-1027, the Company’s lead compound for
the treatment of rheumatoid arthritis and type 1 diabetes (co-developed
with VGX International).
VGX Pharmaceuticals also seeks to further expand its potent DNA vaccine
and delivery platform in 2008. The Company plans to file three separate
INDs for promising DNA vaccine candidates during the first two quarters
of 2008: VGX-3100--a therapeutic vaccine for human papilloma virus (HPV)
as a 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 its patented CELLECTRA™ electroporation
device, which just successfully completed its first tolerability studies
in human volunteers.
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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