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 looks to royalties on cancer diagnostic test with Healthscope
Circadian Technologies (ASX: CIR, OTCQX:CKDXY) has advised that Healthscope Limited has commenced clinical validation study of Circadian’s Cancer Diagnostic for “Cancers of Unknown Primary” (CUP).
Healthscope is the second largest private hospital provider operator in Australian and licensee and development partner for CUP.
It has completed development and validation and is commencing a “beta test” trial amongst Australian oncologists as the final development stage before making the test commercially available.
CUP is a challenging form of cancer in which the site of origin of a tumour cannot be identified using standard approaches.
The diagnostic test method has been developed in collaboration between Circadian, Healthscope, the Peter MacCallum Cancer Centre, a leading specialty cancer centre, and scientists at NICTA (National ICT Australia).
It has been developed based on results obtained from biopsies taken from patients with multiple different tumour types.
Beta testing is expected to be completed early in 2012 with the product becoming commercially available in Australia, New Zealand, Singapore and Malaysia around first quarter of 2012.
Healthscope, through its subsidiary Clinical Laboratories Pty Ltd, has rights to develop, clinically validate and market the test throughout Australia, New Zealand, Malaysia and Singapore.
However, Circadian retains rights to market the test in the remainder of the world.
Healthscope has paid Circadian an upfront fee, and will pay a royalty on sales of the test. Circadian, through its wholly owned subsidiary Cancer Therapeutics Limited, owns exclusive worldwide rights to the test through a licensing arrangement with the Peter MacCallum Cancer Centre and NICTA.
Robert Klupacs, Circadian managing director and CEO stated, “Early diagnosis of the actual tumour type in patients with CUP could have a major effect on treatment options and improve outcomes in patients. We are delighted that Healthscope has reached this milestone after an extensive and intense development program and that the test will be commercially available early next year.
“Royalties from Healthscope sales will provide significant support for our ongoing cancer therapeutic development programs. We also expect to have partnered commercialisation of the test in the major territories of USA and Europe by the second half of 2012.”
Significantly, the CUP diagnostic methodology identifies a patient’s tumour type by comparing its pattern of gene expression to a database of known tumours.
By correctly identifying a patient’s tumour type, clinicians can choose the most effective treatment strategy for the cancer. CUP is generally less well known and publicised than other cancer types.
However, it is actually more common than leukaemia and is the fifth most common cause of death due to cancer in Australia.
Dr Keith Byron, Scientific Director of Healthscope’s Advanced Pathology Division said “Healthscope is excited that after the extensive development program we have undertaken with our partners that we are now on the cusp of commercialising this ground breaking diagnostic technology.
"The test is an important addition to our existing business of providing diagnostic tools for doctors throughout our 43 hospitals and the health care industry in general.”
Prof David Bowtell, Head of the Cancer Genomics Program at the Peter MacCallum Cancer Centre and a co-inventor of the diagnostic methodology added, “It is extremely gratifying that this product of our translational research efforts will be made available to clinicians throughout the region.
"The concept of personalising treatments for patients based on highly specialised diagnostics is now very well accepted in oncology and has been shown to have significant patient benefit. We believe that the assay will lead to earlier diagnosis, improved treatment outcomes and enhanced quality of life for patients.”
Circadian 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.
New Drug Application FDA
Circadian Technologies recently filed 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.
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, this announcement plus today's announcement begins the transition for Circadian into a clinical development company.
