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Bell, PA – October 17, 2007 – |
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VGX Pharmaceuticals has provided the following updates
on the Company’s clinical trials and product development progress:
PICTOVIR™:
The Company has completed dosing of patients in 2 dose groups (300 mg
and 600 mg per day) in a multi-site, multi-dose, and double-blind Phase
II study and has filed a safety report with the FDA summarizing the tolerability
of these doses. VGX is currently working through the FDA requirements
for conducting clinical studies for using PICTOVIR™ in combination
with other front-line treatments without the need to progress to a 1200
mg dose. All current HIV drug regimens use a combination of 3 or 4 drugs
to increase efficacy and to reduce the virus’ development of resistance
to the drugs.
VGX-410C: VGX has completed the dosing
of the last patient in this multi-site, multi-dose, and double-blind Phase
II study for assessing the drug’s safety and antiviral effects and
is conducting follow-up analyses per the clinical protocol. The Company
is on schedule for the unblinding and announcing of all clinical data
by the end of 2007.
VGX-1027: VGX has completed IND-enabling
pre-clinical toxicology studies for VGX-1027 (Type 1 Diabetes and Rheumatoid
Arthritis) and cGMP manufacturing of clinical-grade products. The Company
expects to file an Investigational New Drug Application (IND) with the
FDA in December 2007.
CELLECTRA™: VGX’s patented
electroporation device has been validated for human use. VGX is developing
the CELLECTRA™ electroporation device to deliver a number of DNA
vaccine and therapeutic candidates. This unique technology optimizes DNA
uptake and subsequent expression by adapting an applied electric field
strength in real-time to sense the tissue micro-environment. The device
is portable, water-proof, shock-proof, battery operated, and software
driven, making it particularly suited for usage in the field. The Company
will initiate and complete its first study for tolerability of this device
in human volunteers by the end of 2007.
DNA Vaccines (Syringe Delivery): VGX’s
most advanced DNA vaccines product is PENNVAX-B™, which focuses
on the prevention and treatment of HIV infection. The Company will initiate
2 separate Phase I clinical trials in 2007; one for prophylactic vaccination
and the other for therapeutic vaccination. Both trials will be conducted
in clinical centers in the U.S. in collaboration with the University of
Pennsylvania and the HIV Vaccines Trials Network (HVTN), which is the
largest HIV vaccine testing organization in the world and funded by the
U.S. National Institutes of Health (NIH). VGX is planning additional Phase
I clinical studies for PENNVAX-B™, delivered with CELLECTRA™,
in collaboration with the HVTN for 2008.
DNA Vaccines (CELLECTRA™ Delivery): VGX has initiated IND-enabling
pre-clinical toxicology studies for three of its DNA plasmid-based product
candidates delivered by CELLECTRA™ electroporation device. The candidates
include vaccines for human papilloma virus as a treatment for cervical
cancer (VGX-3100) and avian influenza (VGX-3400), and a therapeutic based
on human growth hormone releasing hormone (VGX-3200) for cancer-related
cachexia. The Company expects to complete the toxicology studies in early
2008, and to file the INDs for all three products by June 2008.
VGX Animal Health Products: VGX has
initiated IND-enabling pre-clinical toxicology studies for three of its
DNA plasmid-based product candidates delivered by CELLECTRA™ electroporation
device. The candidates include vaccines for human papilloma virus as a
treatment for cervical cancer (VGX-3100) and avian influenza (VGX-3400),
and a therapeutic based on human growth hormone releasing hormone (VGX-3200)
for cancer-related cachexia. The Company expects to complete the toxicology
studies in early 2008, and to file the INDs for all three products by
June 2008.
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 includes 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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