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Bell, PA – December 20, 2007 – |
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VGX Pharmaceuticals announced it has submitted an
investigational new drug (IND) application jointly with its affiliate,
VGX International, to the U.S. Food and Drug Administration (FDA) for
Phase I clinical studies of VGX-1027 in healthy volunteers. VGX-1027 is
the Company’s lead drug candidate for the treatment of rheumatoid
arthritis (RA) and type 1 diabetes (T1D). VGX-1027 is a novel orally-active,
small-molecule compound with broad anti-inflammatory properties.
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. Pre-clinical 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.
There are several blockbuster therapeutic agents on the market today which
target the RA indication, including Enbrel® (Global Sales of $4.4
Billion in 2006, by Amgen), Remicade® ($3.6 Billion, J&J), and
Humira® ($1.9 Billion, Abbott). 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.
Additionally, there are very few other treatment options available currently
for T1D patients other than daily insulin injections.
The IND filing for VGX-1027 is an important milestone for our Company,"
stated Dr. J. Joseph Kim, President and Chief Executive Officer. “The
VGX-1027 program represents VGX‘s entry into the important inflammatory
disease field with a lead drug candidate having several potential advantages
over other treatment options.”
Once the IND is approved, VGX will conduct Single Ascending Dose (SAD)
and Multiple Ascending Dose (MAD) Phase I studies on VGX-1027 in 2008.
The Company is currently expecting approval of the IND in the first quarter.
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 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.
About VGX International
VGX International, a publicly-traded global biopharmaceutical company
listed on the Korean Stock Exchange. VGX International is a member of
the KOSPI 200 index and is headquartered in Seoul, Korea. The Company
is dedicated to developing revolutionary new drug candidates for the treatment
of cancer and inflammatory diseases, providing the most advanced cGMP
solutions for better facilities, and supplying high-end biopharmaceutical
products to global clients. The Company's clinical development programs
include VGX-1027 for type 1 diabetes and VGX-100 for gastric cancer, which
are both currently in pre-clinical stages. The Company provides cGMP manufacturing
solutions to other pharmaceutical companies in Asia for new construction
of GMP facilities and its related fields. The Company also provides contract
manufacturing services dedicated to supplying biopharmaceutical products
to global institutions and companies working on DNA therapies. More information
about VGX International can be found at www.vgxi.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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