The U.S. Food and Drug Administration (FDA) today authorized Circadian Technologies Ltd. to initiate clinical trials withits investigational new drug VGX-100. The first Phase I trials will study VGX-100 in patients with a variety of late stage cancers.

VGX-100 is a fully human antibody that acts against the human VEGF-C protein. Treatment for cancers, particularly glioblastoma (GBM), metastatic colorectal cancers, and prostate are the first target indications for VGX-100. Additionally, VGX-100 has been shown to dramatically reduce the frequency of tumour metastatic spread in certain animal models. Preliminary toxicology studies have identified no serious adverse effects of VGX-100 treatment in animals. Circadian is developing VGX-100 for a number of other cancer indications, as well as an agent to treat front-of the-eye diseases.

Important milestone
“The FDA’s acceptance of our IND represents an extremely important milestone for Circadian. We are well advanced in finalizing clinical trial sites in the USA and expect clinical trials to commence before the end of 2011 with results becoming available from the study in the second half of 2012,” said Robert Klupacs, CEO of Circadian Technologies.

Combination with bevacizumab and chemotherapy
Studies in animal model studies across a wide range of tumour types have shown that when combined with bevacizumab (Avastin?, Genentech/Roche) and chemotherapy, VGX-100 can significantly reduce tumour growth and tumour spread as well as significantly improve tumour 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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