BLUE BELL, Pa.--(BUSINESS WIRE)--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 over multiple days.
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 signaling pathways.
Several blockbuster 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.
“We are enthusiastic 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.
About VGX Pharmaceuticals
More information about VGX can be found at www.vgxp.com.
Kevin W. Rassas