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news.Vegenics, a subsidiary of Circadian Technologies, has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to initiate clinical studies of VGX-100.
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VGX-100 is a human antibody that acts against the human VEGF-C protein and is used to treat glioblastoma and metastatic colorectal cancers.
Circadian is also developing VGX-100 for a number of other cancer indications, as well as an agent to treat front-of the-eye diseases.
The data from the preclinical studies have shown that when combined with Avastin and chemotherapy, VGX-100 reduces tumour growth and tumour spread as well as improve tumour inhibition, over and above that of Avastin and/or chemotherapy alone.
Recent studies have also shown that during Avastin treatment VEGF-C acts as a key mediator of disease progression, and when combination therapy of Avastin and VGX-100 are administered it improves treatment outcomes in cancer patients.
Circadian Technologies CEO Robert Klupacs said the company expects to start its first in man Phase I studies as soon as possible after FDA review.