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Bell, PA – April 16, 2008 – |
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VGX Pharmaceuticals announced today that the Company
has granted VGX International, its affiliate based in Seoul, Korea, an
exclusive license to use the Company’s patented CELLECTRA™
adaptive constant current electroporation device to develop novel DNA
vaccines and therapeutics in Korea.
Over the years, VGX Pharmaceuticals has established itself as a leading
developer and manufacturer of DNA plasmid-based vaccines and therapies.
The Company has built extensive, vertically-integrated capabilities including
proprietary SynCon™ DNA-based product candidates, the CELLECTRA™
delivery device, and efficient cGMP manufacturing facilities for its own
product supplies and for contract manufacturing.
Earlier this year, VGX Pharmaceuticals submitted a Device Master File
(MAF) to the U.S. Food and Drug Administration (FDA) for the CELLECTRA™
device. Numerous preclinical efficacy studies have shown that delivery
of DNA-based product candidates with the CELLECTRA™ device improves
DNA uptake and its subsequent expression in the target tissue, and results
in enhanced immune responses in animals. The MAF filing, which includes
technical, manufacturing, and clinical and non-clinical information about
a medical device, facilitates FDA review of the CELLECTRA™ device
whenever Investigational New Drug (IND) applications for DNA-based product
candidates that reference the device’s use are filed. VGX Pharmaceuticals
recently completed a pain and tolerability clinical trial for its electroporator
in healthy volunteers, without the presence of a DNA vaccine, demonstrating
that electroporation with the CELLECTRA™ device is well tolerated.
VGX Pharmaceuticals plans to initiate three Phase I trials using three
of its novel DNA-based vaccines and therapies delivered by the CELLECTRA™
device. VGX Pharmaceuticals has already filed an IND for VGX-3200, a therapeutic
based on human growth hormone releasing hormone (GHRH) for cancer-related
cachexia (wasting or heavy weight loss). The Company also plans to file
two additional INDs for its SynCon™ DNA vaccine candidates during
the second quarter of 2008: VGX-3100, a therapeutic vaccine for the treatment
for cervical cancer and VGX-3400, a pandemic avian flu vaccine.
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, which is in Phase
II clinical trials, PENNVAX™-B for HIV infection, which is in 2
separate Phase I clinical trials, and VGX-1027 for inflammatory diseases,
which is in Phase I clinical trials. In addition, The Company has filed
an IND for VGX-3200, a novel DNA therapy that utilizes GHRH for the treatment
of cancer cachexia and anemia. VGX has established a vertically-integrated
DNA Vaccines and Therapies Platform with extensive capabilities including
SynCon™ DNA-based product candidates, the patented CELLECTRA™
delivery device, and efficient cGMP plasmid manufacturing facilities.
The cGMP facilities are used for VGX’s own product supplies and
for contract manufacturing. Vertical control over key aspects of product
development has enabled the Company to consistently develop multiple product
candidates, from bench-to-IND filing, within 1 year. 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.
About VGX International
VGX International, a publicly-traded global biopharmaceutical company
listed on Korean Stock Exchange. VGX International is a member of the
KOSPI 200 index and is headquartered in Seoul, Korea. The Company is dedicated
to developing revolutionary new drug candidates for the treatment of cancer
and inflammatory diseases, providing the most advanced cGMP solutions
for better facilities, and supplying high-end biopharmaceutical products
to global clients. The Company's clinical development programs include
VGX-1027 for type 1 diabetes and VGX-100 for gastric cancer, which are
both currently in pre-clinical stages. The Company provides cGMP manufacturing
solutions to other pharmaceutical companies in Asia for new construction
of GMP facilities and its related fields. The Company also provides contract
manufacturing services dedicated to supplying biopharmaceutical products
to global institutions and companies working on DNA therapies. More information
about VGX International can be found at www.vgxi.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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