|
|
| Blue
Bell, PA – January 21, 2008 – |
|
VGX Pharmaceuticals announced the submission of a
Device Master File (MAF) to the U.S. Food and Drug Administration (FDA)
for its patented CELLECTRA™ adaptive constant current electroporation
device. The Company has been developing the CELLECTRA™ electroporator
as its lead clinical medical device for delivering DNA vaccine and therapy
products. Numerous preclinical efficacy studies have shown that delivery
of DNA-based product candidates with the CELLECTRA™ device optimizes
DNA uptake and its subsequent expression in the target tissue, and results
in enhanced immune responses in animals.
Filing of the MAF, which includes technical, manufacturing, and clinical
and non-clinical information about a medical device, marks an important
milestone for VGX Pharmaceuticals. It facilitates the FDA review of the
CELLECTRA™ device when Investigational New Drug (IND) applications
for DNA-based product candidates are filed that reference its use. VGX
Pharmaceuticals recently completed a pain and tolerability clinical trial
in healthy volunteers without the presence of a DNA vaccine demonstrating
that electroporation with the CELLECTRA™ device is well tolerated.
“This MAF submission brings the CELLECTRA™ device another
step closer to becoming the device of choice for DNA vaccines and therapies,”
stated Dr. J. Joseph Kim, President and Chief Executive Officer. “Our
aggressive development strategy will continue to validate the value of
our vertically-integrated DNA Vaccines and Therapeutics Platform, which
includes SynCon™ DNA-based product candidates, the CELLECTRA™
device, and efficient and scalable cGMP manufacturing facilities.”
VGX Pharmaceuticals plans to file three INDs for its SynCon™ DNA-based
product candidates during the first two quarters of 2008: VGX-3100, a
therapeutic vaccine for the treatment for cervical cancer; VGX-3200, a
therapeutic based on human growth hormone releasing hormone for cancer-related
cachexia (wasting or heavy weight loss); 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,
and PENNVAX™-B, a DNA vaccine for HIV infection, which is in 2 separate
Phase I clinical trials. The Company’s lead compound for inflammatory
diseases, VGX-1027, is also in Phase I clinical trials. VGX's research pipeline
includes a new generation of SynCon™ DNA vaccines and therapeutics
as well as the CELLECTRA™ electroporator, 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
|
