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| VGX
Pharmaceuticals Announces FDA Acceptance of IND Application for
VGX-410C |
Blue Bell, PA – August 21, 2005 –
VGX Pharmaceuticals today announced that the U.S. Food and Drug
Administration (FDA) has accepted its Investigational New Drug (IND) application
to evaluate its lead compound, VGX-410C for the treatment of chronic Hepatitis
C infection (IND #72,963). The company will start Phase II clinical trials
for VGX-410C by September of 2005.
VGX-410C is an investigational drug for treatment of chronic hepatitis
C infection. Currently approved drugs are effective only in about 30%
to 50% of patients with chronic hepatitis C infection in the United States.
Additionally, those approved drugs are toxic in many patients, resulting
in discontinuation of treatment..
“This is an important milestone both for VGX Pharmaceuticals and
for the treatment of chronic HCV infection,” says J. Joseph Kim,
Ph.D., president and CEO of VGX Pharmaceuticals. “VGX-410C represents
the first drug in a novel class of HCV IRES inhibitors under development.
It is an orally active, small-molecule drug that provides once a day convenience.”
VGX-410C prevents HCV replication by suppressing HCV translation and ultimately
blocking the HCV replication process. As all the genotypes of HCV use
the same pathway, this drug target should be effective for all HCV genotypes.
“VGX-410C could make a significant impact for HCV treatment”
said Dr. Kim.
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 product candidates
for the treatment of infectious diseases including HIV, hepatitis C as well
as cancer and inflammatory diseases. The Company’s clinical development
programs include PICTOVIR™ for HIV infection and VGX-410C for chronic
hepatitis C virus infection. In addition, VGX Pharmaceuticals’ therapeutic
platform is designed to advance a strong and continual pipeline of drug
candidates into the clinic with novel product candidates to treat cancer
and inflammatory diseases. 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
Vice President
Tel 267.440.4208
Fax 267.440.4242
E-mail: Rassas@vgxp.com
www.vgxp.com
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