Vegenics receives IND approval from FDA for VGX-100 Phase I study in late stage cancers

Oct 31 2011

Circadian Technologies Limited (ASX: CIR, OTCQX: CKDXY) announces that its 100% owned subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate clinical trials of VGX-100. The first trial (Phase I) will study VGX-100 in patients with a variety of late stage cancers.

"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 Limited.

VGX-100 is a human antibody that acts against the human 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, as well as an agent to treat front-of the-eye diseases.

Studies 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 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.

Circadian's wholly owned subsidiary, Vegenics Pty Ltd, owns worldwide rights to an extensive intellectual property portfolio covering the angiogenesis and lymphangiogenesis targets VEGF-C, VEGF-D and the receptor protein VEGFR-3. Vegenics has also been granted exclusive worldwide rights to intellectual property filed by Schepens Eye Research Institute, covering the use of anti-lymphangiogenc molecules for the treatment of Dry Eye Disease.