Circadian Technologies (ASX: CIR) is an Australian biotechnology company developing innovative, biologics-based therapies for the treatment of cancer and other serious human illnesses.
Circadian owns an extensive portfolio of products and intellectual property related to Vascular Endothelial Growth Factors (VEGFs), a class of proteins that play a critical role in regulating tumour blood supply.
Circadian Technologies files IND with FDA for VGX-100, moves into clinical development phase
The filing of the IND is a significant move for Circadian into the clinical phase of testing in oncology. With cash of $22.1 million at June 30, enough for two years of funding, today's announcement begins the transition for Circadian into a clinical development company.
Circadian Technologies (ASX: CIR, OTCQX:CKDXY) has taken a significant step forward, filing a new drug application to the U.S. Food and Drug Administration (FDA) to start clinical studies for its VGX-100 antibody to treat cancer.
An Investigational New Drug Application (IND) is a request for authorization from the U.S. Food and Drug Administration (FDA) to administer an investigational drug to humans.
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 focussed 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.
The filing of the IND represents a significant move for Circadian into the clinical phase of testing in oncology.
After filing the IND, it is likely that Circadian could start dosing cancer patients with VGX-100 in late 2011 or early 2012.
Circadian is well placed to execute on its strategy as cash in hand at June 30 stood at $22.1 million, representing two years of funding.
Robert Klupacs, CEO of Circadian Technologies said, “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.”
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.
The IND Process
During a new drug's preclinical development, a company focuses on generating scientific data and information necessary to establish that the product will not expose humans to unreasonable risks when used in clinical studies.
The IND application is made to the FDA and must contain information in three broad areas:
- Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment of the activity of the drug and whether the product is reasonably safe for initial testing in humans
- Manufacturing Information - Information pertaining to the composition, manufacturer, stability and controls used for manufacturing the drug substance and the drug product
- Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks
Once an IND is submitted, the applicant must wait 30 calendar days before initiating any clinical trials. During this time, the FDA reviews the data in the IND and determines the conditions under which human trials can commence.
