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| VGX
Pharmaceuticals Announces FDA Acceptance of IND Application for
PICTOVIR™ (formally known as VGX-410)
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Philadelphia, PA – December 1,
2004 –
VGX Pharmaceuticals announced today that the U.S. Food and Drug Administration
(FDA) has accepted the Investigational New Drug (IND) application to evaluate
its lead compound, PICTOVIR™ (formally
known as VGX-410) for the treatment of HIV infection. The company and
the AIDS Clinical Trials Group (ACTG) will start Phase I/II clinical trials
for PICTOVIR™ in January of 2005.
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. Patients
desperately need a new class of drug compound to combat drug resistances
observed with existing compounds.
"This is an important milestone both for VGX Pharmaceuticals and
for the treatment of HIV infection," says J. Joseph Kim, Ph.D., President
and CEO of VGX Pharmaceuticals. "PICTOVIR™
represents the first drug targeting Pre-Integration Complex Translocation
(PICT) that could significantly reduce mutation effects of the virus.
It is an orally active, small-molecule drug that provides once a day convenience.
"PICTOVIR™ works by inhibiting
the binding of one of HIV-1 virus' accessory proteins, Vpr, to its receptors.
Vpr plays an important role for the survival of the HIV-1 virus in human
cells, and by inhibiting it the virus is unable to replicate in many of
the body's important immune cells. 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. "PICTOVIR™ could make
a significant impact for HIV 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,"
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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 AIDS Clinical Trials Group (ACTG)
The AIDS Clinical Trials Group (ACTG), the largest HIV clinical trials organization
in the world, plays a major role in setting standards of care for HIV infection
and opportunistic diseases related to HIV/AIDS in the United States and
the developed world. The ACTG is composed of, and directed by, leading clinical
scientists in HIV/AIDS therapeutic research. The ACTG is funded by the Department
of Health and Human Services, National Institutes of Health through the
National Institute of Allergy and Infectious Diseases.
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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