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VGX Pharmaceuticals Announces Preliminary
Results
on the Phase I/II Clinical Trials of PICTOVIR™ |
BLUE BELL, P.A. – December 29, 2005 –
VGX Pharmaceuticals announced that the Company has received preliminary
results on the first Phase I/II clinical trials of PICTOVIR™, a
lead drug compound for the treatment of HIV infection. This double-blinded,
placebo-controlled, multi-center, multi-dose, randomized, Phase I/II study
was conducted in collaborations with the Adult AIDS Clinical Trials Group
(AACTG).
The preliminary results indicate that:
- All 3-dose levels were safe and well tolerated.
- There was an indication of antiviral effects at
the highest dose tested (225 mg).
- More laboratory tests are currently underway to
evaluate whether these dose levels of PICTOVIR™ improved immune
function in HIV-1 infected patients and also to determine the drug levels
of PICTOVIR‘ achieved during the study in the patients’
blood.
Based upon the preliminary results, the company is
currently planning to conduct additional Phase II clinical trials for
PICTOVIR™ with higher dosage levels to determine the dosage level
necessary to achieve a clinically significant antiviral effect. The next
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.
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. In studies
of PICTOVIR™ in non-human primates, the drug has been shown to effectively
reduce viral load in monkeys infected with drug-resistant viruses.
“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
a first-in-class HIV Pre-Integration Complex Translocation Inhibitor (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™ 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,"
"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 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. 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 (NIH) 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 infection that are currently in Phase II clinical trials. 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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