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Avaxia Biologics Receives IND Clearance from FDA for AVX-470

Published: Tuesday, November 27, 2012
Last Updated: Tuesday, November 27, 2012
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Clearance granted to initiate clinical program to evaluate AVX-470 as therapy for ulcerative colitis.

Avaxia Biologics, Inc. announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for AVX-470 for the treatment of ulcerative colitis. AVX-470 is an anti-TNF polyclonal antibody and is the first clinical candidate to come from Avaxia's oral antibody platform. The Company expects to initiate a Phase 1b clinical trial of AVX-470 in patients with active ulcerative colitis in the near term.

"Clearance of the IND allows us to advance AVX-470 into clinical development, which furthers our goal of providing patients afflicted with inflammatory bowel disease with a promising new treatment option," stated Barbara S. Fox, CEO of Avaxia. "Because AVX-470 is delivered directly to the GI tract, it has a lower potential for systemic immunosuppression than injectable anti-TNF therapies while potentially retaining the proven benefits of anti-TNF antibody therapy for inflammatory bowel disease."

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