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Bell, PA – January 14, 2008 – |
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VGX Pharmaceuticals announced today that the U.S.
Food and Drug Administration (FDA) accepted the Investigational New Drug
(IND) application for its lead anti-inflammatory compound, VGX-1027. VGX-1027
is an orally active, small molecule compound that has shown preclinical
efficacy against various inflammatory diseases including Rheumatoid Arthritis
(RA) and Type 1 diabetes (T1D).
VGX-1027 is the first of a new class of immune modulators that inhibits
the production of several pro-inflammatory cytokines, which are responsible
for the damaging effects of inflammatory diseases. Preclinical studies
have shown that VGX-1027 is effective in inhibiting these cytokines in
cell cultures. They have also demonstrated the product’s efficacy
in animal models for several diseases including RA, T1D, psoriasis, and
colitis. Its main mechanism of action is the inhibition of NF-kB and the
early transient inhibition of P38 MAP kinase signaling pathways.
Inflammatory diseases including RA, T1D, psoriasis, and colitis represent
major medical problems. In the U.S. alone, over 2.7 Million people suffer
from rheumatoid arthritis. An additional 1 Million Americans suffer from
type 1 diabetes, which can be fatal if untreated.
Several blockbuster therapeutic agents dominate the multi-billion dollar
RA drug market. However, all of these agents require injection into a
patient’s muscle or skin. VGX-1027 offers a distinct advantage over
such products because it can be taken as a once-a-day pill. There are
very few treatment options available for T1D patients other than insulin,
which requires daily injections.
“VGX looks forward to promptly initiating Phase I clinical trials
for VGX-1027, which has several potential advantages over other treatment
options," stated Dr. J. Joseph Kim, President and Chief Executive
Officer.
VGX will conduct Single Ascending Dose (SAD) and Multiple Ascending Dose
(MAD) in its Phase I studies on VGX-1027. Upon successful completion,
the results from these studies will satisfy FDA requirements to commence
two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals,
and one for T1D patients, to be conducted by 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. 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.
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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