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news.VGX Pharmaceuticals has submitted an investigational new drug application to the FDA for Phase I clinical studies of VGX-1027 in healthy volunteers.
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Once the IND is approved, VGX will conduct single ascending dose (SAD) and multiple ascending dose (MAD) Phase I studies on VGX-1027 in 2008. The company is currently expecting approval of the IND in the first quarter. Upon successful completion, the results from these studies will satisfy FDA requirements to commence two Phase II studies: one for rheumatoid arthritis patients, to be conducted by VGX Pharmaceuticals, and one for type 1 diabetes patients, to be conducted by VGX International.
VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines, which are responsible for the damaging effects of inflammatory diseases. Pre-clinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. Its main mechanism of action is the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.
VGX-1027 is the company’s lead drug candidate for the treatment of rheumatoid arthritis and type 1 diabetes.
Joseph Kim, president and CEO of VGX Pharmaceuticals, said: “The VGX-1027 program represents VGX’s entry into the important inflammatory disease field with a lead drug candidate having several potential advantages over other treatment options.”