Circadian subsidiary submits IND application to FDA to initiate VGX-100 study against cancer

Oct 1 2011

Circadian Technologies Limited (ASX: CIR, OTCQX:CKDXY) is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical studies of VGX-100. The first trial (Phase I) will involve the treatment of a variety of different cancer types in patients with late stage cancer.  

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.

Preclinical 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.

"VGX-100 has the potential to significantly improve the treatment of patients suffering from cancer. The IND filing is an important milestone for us, as it completes our pre-clinical phase of development and transitions Circadian into a clinical development company. We expect to commence our first in man Phase I studies as soon as possible after FDA review. We also expect to see results from the study in the second half of 2012," stated Robert Klupacs, CEO of Circadian Technologies Limited.

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-lymphangiogenic molecules for the treatment of Dry Eye Disease.