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| VGX Pharmaceuticals Announces FDA Acceptance of IND for PICTOVIR™
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Bell, PA – April 7, 2006 – |
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VGX Pharmaceuticals announced today that the U.S. Food
and Drug Administration (FDA) has accepted its Investigational New Drug
(IND) application for additional Phase II clinical studies for PICTOVIR™,
its lead drug compound for the treatment of HIV infection (IND #: 74,494).
PICTOVIR™ is an investigational drug for the treatment of HIV infection.
Currently 30 to 50 percent of patients who are treated with current drugs
regimens develop resistance to one or more antiretroviral drugs, reducing
the treatment options available to them. Since there is no effective cure
or vaccine for AIDS, HIV drug resistance has become a serious treatment
failure and concern. There is a great need for a new class of drug compound
to combat drug resistances observed with existing compounds.
The first PICTOVIR™ Phase I/II clinical study was completed in 2005 under
an IND held by the National Institutes of Allergy and Infectious Diseases
in a close collaboration with VGX Pharmaceuticals. Based upon the clinical
study results, the Company has decided to open its own IND to support
additional Phase II clinical trials for PICTOVIR™ with higher doses to
determine the dosage level necessary to achieve a clinically significant
antiviral effect. This Phase II clinical study is planned to begin enrolling
patients in the second quarter of 2006. The company also expects to initiate
other Phase III-enabling studies of the drug, including the drug-drug
interaction studies in 2006.
"This is another important clinical milestone for VGX Pharmaceuticals,"
says J. Joseph Kim, Ph.D., President and CEO of VGX Pharmaceuticals. "PICTOVIR™
is a first drug in a new class of HIV drugs targeting the Pre-Integration
Complex Translocation (PICT). It is an orally active, small-molecule drug."
PICTOVIR™ works by preventing the transporting of PIC to the nucleus of
many of the body's important immune cells. By inhibiting this mechanism,
PICTOVIR™ can prevent the replication of HIV. In cell culture assays and
in animal models, treatment of virus infected human primary cells by PICTOVIR™
at low doses resulted in a significant inhibition of viral replication
of all of the laboratory-adapted and clinical primary isolates of HIV-1
virus. Additionally, in studies of PICTOVIR™ in non-human primates, the
drug has been shown to effectively reduce viral load in monkeys infected
with multi drug-resistant (MDR) viruses. "PICTOVIR™ could make a significant
impact for HIV treatment," said Dr. Kim.
"With an expedient IND approval by the FDA, VGX will aggressively initiate
this additional study for the development of PICTOVIR™," 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 leading biopharmaceutical company with strong product
candidates for the treatment of infectious diseases including HIV and hepatitis
C virus (HCV) as well as cancer and inflammatory diseases. The Company’s
clinical development programs include PICTOVIR™ for HIV infection
and VGX-410C for chronic HCV infection, which are currently in Phase II
clinical trials. In addition, a Phase I clinical trial will be initiated
in 2006 for the Company’s lead cancer drug compound, VGX-150 for the
treatment of Melanoma. Moreover, VGX Pharmaceuticals’ therapeutic
platform is designed to advance a strong and continual pipeline of additional
drug candidates into the clinic with VGX-100 for cancer therapy and VGX-1027
and VGX-750 for inflammatory diseases currently in development. 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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