January 8, 2012, Melbourne, Australia—Circadian Technologies Limited (ASX:CIR, OTCQX:CKDXY) announced today that it has commenced the first Phase 1 clinical trial of its fully human monoclonal antibody against VEGF-C, VGX-100, at a leading US-based cancer treatment centre.
The Phase 1 study will examine the safety and tolerability of escalating doses of VGX-100 in patients with advanced solid tumours who have no other standard treatment options both as a monotherapy and also when used in combination with other anti-angiogenic agents. Results from the trial are expected to be available in the second half of 2012.
“We are extremely proud to have completed the translation of VGX-100 from early discovery to the clinical development stage. We are committed to improving outcomes for patients suffering from cancer, and believe that VGX-100, especially when combined with existing therapies could make a significant difference. Commencing clinical trials with VGX-100 is an extremely important achievement for Circadian and a major step in our goal to develop VGX-100 as a new therapeutic agent in the fight against cancer,” 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/or 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-lymphangiogenic molecules for the treatment of Dry Eye Disease.
About Circadian Technologies Limited
Circadian (ASX:CIR; OTCQX:CKDXY) is a biologics drug developer focusing on cancer and ‘front of the eye’ disease therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around Vascular Endothelial Growth Factor (VEGF)-C and -D. The applications for the VEGF technology, which functions in regulating blood and lymphatic vessel growth, are substantial and broad. Circadian’s internal product development programs are primarily focussed on developing VGX-100 (a human antibody against VEGF-C) as a treatment for solid tumours, in particular glioblastoma and colorectal cancer, as well as for ‘front of the eye’ disease such as corneal neovascularisation and/or corneal allograft rejection. Circadian has also licensed rights to some parts of its intellectual property portfolio for the development of other products to ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, including the antibody IMC-3C5 targeting VEGFR-3.