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VGX Pharmaceuticals announces filings of two separate INDs covering
novel DNA vaccines: one for cervical cancer therapy (VGX-3100)
and one for avian influenza (VGX-3400)
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Bell, PA – May 19, 2008– |
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VGX Pharmaceuticals announced
today that it has submitted two separate investigational new drug (IND)
applications to the U.S. Food and Drug Administration (FDA) for Phase
I clinical studies of VGX-3100 and VGX-3400. Both candidate vaccines are
based on VGX’s SynCon™ vaccine technology, and they have been
developed using VGX’s integrated DNA Vaccines and Therapies Platform.
VGX-3100 is a DNA-based therapeutic vaccine that has the potential to
treat cervical cancer caused by the human papilloma virus (HPV). VGX-3100
utilizes synthetic consensus sequences based on HPV antigens that offer
coverage across different viral sub-types (types 16 and 18), which could
potentially treat 71% of all cervical cancers. Although prophylactic vaccines
for HPV, including Merck’s Gardasil® and GSK’s Cervarix™,
have been recently approved, no therapeutic vaccine for HPV has been approved
to date. Furthermore, studies suggest that these approved prophylactic
vaccines do not have any therapeutic effects in women who are already
infected with HPV.
VGX-3400 is a SynCon™ DNA-based preventative vaccine targeting avian
influenza (AI). In pre-clinical studies, vaccination with VGX-3400 generated
protective levels of hemagglutination inhibition (HAI) titers in 100%
of the immunized animals in five separate animal models - mice, ferrets,
rabbits, pigs, and rhesus monkeys. Vaccination with VGX-3400 also protected
100% of the animals from an unmatched, pathogenic H5N1 virus challenge
in mouse and ferret models. VGX-3400 also induced significant levels of
antigen-specific CD8+ killer T cell responses.
“Filing of these INDs with the FDA marks a significant milestone
for our Company,” stated Dr. J. Joseph Kim, President and Chief
Executive Officer. “Using our vertically integrated product development
platform, we have taken three independent product programs from ‘Bench
to IND filing’ within 12 months. These accomplishments demonstrate
the potential and efficiency of our product development platform.”
VGX Pharmaceuticals’ SynCon™ DNA vaccine antigens are designed
by aligning numerous primary sequences and choosing the most common and/or
relevant amino acid at each site using high-powered and patented approaches.
The gene sequences are then further optimized for expression and immunogenicity.
The SynCon™ DNA vaccines in combination with the CELLECTRA®
delivery device provide greater levels of cross-reactive immune responses
than those produced by more traditional vaccines. In pre-clinical animal
studies, delivery of both VGX-3100 and VGX-3400 was improved with the
CELLECTRA® device.
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,"
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"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
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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
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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
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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.
About VGXI Inc.
VGXI Inc. is a leading manufacturer of DNA plasmids, and its cGMP and
non-cGMP products have passed rigorous reviews by several international
regulatory agencies. VGXI offers a wide variety of contract manufacturing
services to outside client organizations. The Company’s cGMP manufacturing
facility in The Woodlands, Texas is a flexible, purpose-built facility
used for research, development, and clinical supply. The site includes
500-liter and 100-liter fermentors and incorporates a cost-effective process.
VGX International also has initiated a project to build and operate a
3000-liter scale cGMP, DNA plasmid manufacturing facility in Asia.
Company Contact:
Henry Hebel
Vice President, Manufacturing and Operations
Tel. 281.296.7300
Fax 281.296.7333
E-mail: hhebel@vgxii.com
www.vgxii.com
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