VGX-100 Investigational New Drug Application Approved


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The Australian biotechnology company Circadian Technologies announced that its subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the FDA to initiate clinical trials of VGX-100. The first phase I trial will study VGX-100 in patients with a variety of late-stage cancers.

VGX-100 is a human antibody that acts against the human vascular endothelial growth factor (VEGF)-C protein. Treatment for cancers, particularly glioblastoma and metastatic colorectal cancers, are the first target indications for VGX-100. Additionally, Circadian is developing VGX-100 for a number of other cancer indications, and as an agent to treat front-of the-eye diseases.

Studies in animal model studies across a wide range of tumor types have shown that when combined with bevacizumab (Avastin) and chemotherapy, VGX-100 can significantly reduce tumor growth and spread as well as significantly improve tumor inhibition, over and above that of bevacizumab and/or chemotherapy alone. Recent studies have also implicated VEGF-C as a key mediator of disease progression during bevacizumab treatment, implying that combination therapy with VGX-100 and bevacizumab could significantly improve treatment outcomes in cancer patients. ■



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