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VGX Pharmaceuticals
Announces the Completion of Patient Enrollment
for the Company’s Phase II Trial for VGX-410C
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Bell, PA – September 2, 2007 – |
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VGX Pharmaceuticals announced the completion of patient
enrollment for VGX-410C, its lead product candidate for treating HCV infection.
VGX-410C is currently in a multi-site, multi-dose, and double-blind Phase
II study for assessing the drug’s safety and antiviral effects.
VGX had completed the patient enrollment stage for the lower dosage arms
(150 mg & 300 mg) earlier in 2007. The Company has now completed enrollment
of the last patient in the highest dosage group (600 mg). The patients
are treated with either drug or placebo for 28 days and are also followed
for additional 28 days. These studies are currently conducted at the University
of Connecticut, Orlando Clinical Research Center and the University of
Pennsylvania. VGX Pharmaceuticals expects the final data to be unblinded
and the Phase II studies for VGX-410C be completed by the end of 2007.
VGX-410C represents the first drug in a novel class of HCV IRES inhibitors
under development. VGX-410C prevents HCV replication by suppressing HCV
translation and ultimately blocking the HCV replication process. It is
an orally active, small-molecule drug.
In addition, the Company also stated that PICTOVIR™, a novel anti-HIV
compound, has completed dosing of patients in 2 lower dose groups (300
mg and 600 mg per day) in a multi-site, multi-dose, and double-blind Phase
II study for assessing the drug’s safety and anti-HIV effects. The
Company is now preparing a safety report to the FDA summarizing the tolerability
of these doses in HIV infected patients and to determine whether to test
a higher dose of PICTOVIR™ (1200 mg) or a lower dose PICTOVIR™
used in combination with other front-line treatments. All current HIV
drug regimens consist of 3 or 4 drugs used in combination to increase
efficacy and reduce the development of resistance of the virus to the
drugs.
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 include a new
generation of DNA vaccines and therapeutics as well as CELLECTRA™,
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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