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Bell, PA – November 12, 2007 – |
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VGX Pharmaceuticals’ SynCon™ pandemic
flu DNA vaccines (VGX-3400) provided protection against a lethal challenge
of live H5N1 viruses, according to data presented today by Dr. Ruxandra
Draghia-Akli at the MVAF 2007-Modern Vaccines/Adjuvants Formulation Conference
in Dublin, Ireland.
Dr. Draghia-Akli, VGX’s Vice President of Research, presented study
data showing that ferrets treated with VGX’s rationally constructed
SynCon™ pandemic flu DNA vaccines were fully protected from illness
and subsequent death in a challenge using an unmatched Vietnamese strain
of avian flu virus. During the experiments, 100% of the ferrets treated
with VGX-3400 survived, while 100% of the control animals died. Ferrets
represent the most relevant pre-clinical influenza animal model for humans,
and data from previous experiments demonstrate that VGX-3400 also protects
mice from the unmatched Vietnamese strain of avian flu virus. All vaccines
used were delivered with VGX’s patented CELLECTRA™ DNA delivery
device. The results of both challenges should strongly support an Investigative
New Drug (IND) application for VGX-3400, which the Company expects to
file by 2Q 2008.
Dr. Draghia-Akli also showed that vaccination with VGX-3400 generated
potent neutralizing antibody and cell-mediated immune responses in four
separate animal models - mice, ferrets, pigs, and rhesus monkeys. More
specifically, VGX-3400 induced protective levels of hemagglutination inhibition
(HAI) titers in 100% of the immunized animals for all 4 models. VGX-3400
also induced significant levels of antigen-specific CD8+ killer T cell
responses.
“Our data further demonstrates the potential of our DNA vaccine
and delivery approaches in addressing a significant global health problem,”
stated Dr. J. Joseph Kim, President and CEO of VGX. “VGX-3400 is
just the first step in executing our strategy for developing a universal
flu vaccine.”
VGX Pharmaceuticals’ SynCon™ DNA vaccine antigens are designed
by aligning numerous primary sequences and choosing the most common amino
acid or base pair at each site by using high-powered and patented bioinformatics
approaches. The SynCon™ DNA vaccines in combination with the CELLECTRA™
delivery device provide greater levels of cross-reactive immune responses
than those produced by more traditional vaccines.
Over the years, VGX Pharmaceuticals has also established itself as a leading
manufacturer of cGMP-grade DNA plasmids. Most recently, the Company expanded
its cGMP manufacturing facility in The Woodlands, Texas to a 500-liter
scale and initiated a project to build and operate a 3000-liter cGMP manufacturing
facility in Korea with its affiliate, VGX International.
VGX Pharmaceuticals has already initiated IND-enabling pre-clinical toxicology
studies for VGX-3400 and two other DNA plasmid-based product candidates:
a vaccine for human papilloma virus for the treatment of cervical cancer
(VGX-3100) and a therapeutic based on human growth hormone releasing hormone
(VGX-3200) for cancer-related cachexia. The Company expects to complete
the toxicology studies and to file the INDs for all three products in
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 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 pipeline includes a new
generation of DNA vaccines and therapeutics as well as 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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