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Circadian Technologies moves into clinical development phase on approval of IND for cancer drug

The FDA’s approval of Circadian’s Investigational New Drug application for its antibody to treat cancer means the company is now well placed to begin the transition to a clinical development company.

Circadian Technologies (ASX: CIR) will soon begin clinical trials of its VGX-100 antibody to treat cancer after its wholly owned subsidiary, Vegenics, received U.S. Food and Drug Administration (FDA) approval for its Investigational New Drug application to initiate clinical trials of VGX-100.

Chief executive Robert Klupacs said the FDA's acceptance of the company’s Investigational New Drug application represents an extremely important milestone for 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,” he said.

The first trial, or Phase I, will involve the treatment of a variety of different cancer types in patients with late stage cancer.

Circadian is focused on developing VGX-100, a human antibody against VEGF-C, as a treatment for solid tumours – including glioblastoma and colorectal cancer – as the first target indications for VGX-100.

VGX-100 works by blocking the growth of lymphatics.  Circadian has already invested considerably in the VGX-100 molecule in terms of manufacturing, toxicology studies and other pre-clinical activities.

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 to date

Preclincial 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, studies have shown that VGX-100 can 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.

Late last month Circadian filed its Investigational New Drug application, which is a request for authorisation from the FDA to administer an investigational drug to humans.