|
|
| VGX
Pharmaceuticals Announces IND Submission for PICTOVIR™
|
Blue Bell, PA – November 1, 2004
–
VGX Pharmaceuticals announced today the submission of an Investigational
New Drug Application (IND) was filed with the Food and Drug Administration
(FDA), for PICTOVIR™, its leading compound for the treatment of
HIV infection. VGX plans to conduct the double-blinded, placebo- controlled,
multi-center, multi-dose, randomized Phase I/II study in collaboration
with the Adult AIDS Clinical Trials Group (AACTG).
Currently 30 to 50 percent of patients who are treated with available
drug regimens develop resistance to one or more antiretroviral drugs,
reducing the treatment options available to them. Since there is no known
effective cure or vaccine for AIDS, HIV drug resistance has become a serious
treatment failure and concern. Consequently, there is a great need for
a new class of drugs to combat the 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.
“We are very excited to submit the IND to initiate Phase I/II development
of PICTOVIR™. We look forward to the approval of the IND by the
FDA so that the associated clinical trials can get underway as quickly
as possible” said J. Joseph Kim, PhD., President and Chief Executive
Officer of VGX.
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 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
|
