Follow-On Phase I Study For Novel Oral Anti-Inflammatory Drug Targeting Rheumatoid Arthritis And Type 1 Diabetes

Main Category: Diabetes
Also Included In: Arthritis / Rheumatology;  Clinical Trials / Drug Trials
Article Date: 01 Oct 2008 - 8:00 PDT

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VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study. VGX-1027 is an orally active, small molecule compound that has shown preclinical efficacy against various inflammatory diseases including rheumatoid arthritis (RA) and Type 1 diabetes (T1D).

VGX-1027 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. They have also demonstrated the product's efficacy in animal models for several diseases including RA, T1D, colitis, and uveitis. Its mechanism of action includes the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.

Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 million people suffer from rheumatoid arthritis. An additional 1 million Americans suffer from type 1 diabetes, which is fatal if untreated.

Several blockbuster therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug market. However, these agents require parenteral (e.g. such as intravenous) delivery. There are few treatment options available for T1D patients other than insulin, which requires daily injections. VGX-1027 is being investigated as an oral therapeutic.

"VGX looks forward to the results of the MAD studies for VGX-1027. Successful completion of the MAD studies would allow initiation of two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by VGX International," stated Dr. J. Joseph Kim, President and Chief Executive Officer.

About VGX International

More information about VGX International can be found at http://www.vgxi.com.

About VGX Pharmaceuticals

More information about VGX can be found at http://www.vgxp.com.

VGX Pharmaceuticals