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VGX Pharmaceuticals Oral Anti-Inflammatory Drug
Safe in Phase I Study
Multiple ascending dose study finds VGX -1027 safe, well-tolerated, and orally bio-available
Blue Bell, PA - March 26,
VGX Pharmaceuticals, a
biopharmaceutical company that is developing vaccines and therapeutics for infectious
diseases, cancer and inflammatory diseases, announced today the completion of a
Phase I multiple ascending dose (MAD) study that demonstrated that its lead oral
anti-inflammatory compound, VGX -1027,
was generally safe and well tolerated. The
orally delivered drug achieved significant and sustained plasma levels after
multiple doses in healthy volunteers, demonstrating favorable pharmacokinetics. The study enrolled 40 healthy volunteers in
four groups to receive the drug orally at daily dose levels spanning 40-400 mg
VGX -1027 is an orally active, small molecule compound
that has shown preclinical efficacy in animal models against various
inflammatory diseases including rheumatoid arthritis (RA), Type 1 diabetes
(T1D), colitis, and uveitis. It is the
first of a new class of immune modulators that inhibits the production of
several pro-inflammatory cytokines responsible for the damaging effects of
inflammatory diseases. Preclinical studies have shown that VGX -1027 is effective in inhibiting these cytokines in
cell cultures. Its mechanism of action includes
the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase
therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug
market. However, these agents require parenteral (such as intravenous) delivery.
There are fewer treatment options available for patients with colitis. VGX -1027 is being investigated as an oral drug.
about the pre-clinical efficacy, clinical safety and pharmacokinetic profile of
this drug candidate. Its novel mechanism
of action and oral bioavailability are key differentiators for the inflammatory
disease market, stated Dr. J. Joseph Kim, President and Chief Executive
Officer. VGX looks forward to
initiating follow on Phase II studies for VGX -1027.
Inflammatory diseases
including RA, T1D, psoriasis, and colitis represent major medical problems. In
the U.S. alone, over 2.7 million people suffer from RA. An additional 1 million Americans suffer from
T1D and colitis, which is fatal if untreated.
VGX Pharmaceuticals is jointly
developing VGX -1027 with its
affiliate, VGX International.
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Our actual results may vary materially, and there are no guarantees about the
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VGX International, a publicly-traded global biopharmaceutical company
listed on the Korean Stock Exchange, is headquartered in
Seoul, Korea. The Company is dedicated to providing the most advanced cGMP
solutions and supplying high-end biopharmaceutical products to clients
worldwide, and to developing new drug and vaccine candidates. VGX International
is currently co-developing VGX -1027 for Type 1 diabetes and VGX -3400 for avian influenza with its affiliate, VGX Pharmaceuticals. The Company has a CMO unit in The Woodlands, Texas and is in the process of
expanding its capacity with the construction of a new manufacturing facility in
Korea. More information about VGX International can be found at www.vgxi.com.
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company
with DNA vaccines and small molecule product candidates for the treatment of
infectious diseases, cancer, and inflammatory diseases. VGX s clinical
development programs include PENNVAX -B for HIV infection, which
is in two separate Phase I clinical trials, as well as VGX -1027 for
inflammatory diseases and VGX -3100, a DNA therapeutic
vaccine for cervical cancer, both of which are in Phase I clinical trials. In
addition, VGX has filed INDs for VGX -3200, a novel DNA therapy
that utilizes GHRH for the treatment of cancer cachexia and anemia and for VGX -3400, a
DNA preventative vaccine for avian influenza. VGX has established a
vertically-integrated DNA Vaccines and Therapies Platform with extensive
capabilities including SynCon DNA-based product candidates, the CELLECTRA electroporation delivery device, and access to
efficient cGMP plasmid manufacturing. Vertical control over key aspects of
product development has enabled VGX to consistently develop multiple product
candidates, from bench-to-IND filing, within one year. The product candidates
and technology programs are protected by the VGX s extensive global
intellectual property portfolio. The Company has entered into a definitive
merger agreement with Inovio Biomedical Corporation (INO: NYSE Alternext). More
information about VGX can be found at www.vgxp.com.
Senior Vice-President
E-mail: Rassas@vgxp.com