Circadian to start phase I trials for cancer drug after receiving IND approval

Melboure-based Circadian Technologies (ASX:CIR) has been granted approval by the U.S. Food and Drug Administration for its investigational new drug (IND) application for VGX-100, paving the way for phase I trials to commence.

VGX-100 is a human antibody that acts against the human VEGF-C protein, and is being developed for treatment for cancers, particularly 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.

Studies conducted by Circadian in animal model studies across a wide range of tumour types have shown that when combined with Avastin and chemotherapy, VGX-100 can significantly reduce tumour growth and tumour spread as well as significantly improve tumour inhibition, over and above that of Avastin and/or chemotherapy alone.

Recent Circadian studies have also implicated VEGF-C as a key mediator of disease progression during Avastin treatment, implying that combination therapy with VGX-100 and Avastin could significantly improve treatment outcomes in cancer patients.

“The FDA’s acceptance of our IND represents an extremely important milestone for Circadian,” said Robert Klupacs, CEO of Circadian.

“We are well advanced in finalising 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.”

Circadian’s (ASX:CIR) share price was unmoved at 50.5c near the close of trading on Friday.