VGX Pharmaceuticals’ Oral Anti-Inflammatory Drug Safe in Phase I Study

Mar 26, 2009

BLUE BELL, Pa.--()--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.

Contacts

VGX Pharmaceuticals
Kevin W. Rassas
Senior Vice-President
267-440-4208
Fax: 267-440-4242
Rassas@vgxp.com

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