World First Clinical Trial of New Cancer Drug by Australia’s Asbestos Diseases Research Institute
Today, Australia’s Asbestos Diseases Research Institute announced a world-first clinical trial into a newly developed drug therapy for the treatment of mesothelioma, a cancer which is almost uniquely caused by exposure to asbestos fibers and is currently incurable. While the preclinical research was confined to mesothelioma, we hope this new approach to cancer treatment will also inhibit other tumour types. There is experimental evidence supporting this so the outcomes are eagerly awaited.
By: Asbestos Diseases Research Institute
In most patients with mesothelioma the disease has significantly advanced before symptoms appear, making an early diagnosis and effective treatment very difficult. There is no cure. The average survival time after diagnosis is 6-18 months.
Following a three year study to characterise the gene expression in mesothelioma, ADRI’s research revealed a particular family of microRNAs (small genes involved in the regulation of cell and tumour biology) was significantly decreased.
This family of microRNAs is well known for its involvement in the biology of other cancers however this is the first time it has been linked to mesothelioma.
When levels of the microRNA family were returned to normal in tumour cell lines by adding synthetic versions of the microRNAs, the growth of the tumour cells was inhibited but importantly, normal cells remained unaffected, suggesting the treatment has minimal side-effects.
The major issue hampering the clinical use of these microRNAs is their specific delivery to tumour cells. To solve this problem ADRI collaborated with Sydney-based biotech company EnGeneIC, inventors of minicells, a new drug delivery system able to transport a drug to the tumour area guided by antibodies.
Using this new approach, mice with human mesothelioma-
Together, these pre-clinical observations formed the basis of the clinical trial protocol.
The first stage of the clinical trial on humans of this unique experimental therapy, TargomiRs, for malignant pleural mesothelioma patients will take about a year to complete.
Professor Nico van Zandwijk, Director of the Asbestos Diseases Research Institute (the world’
“To do this we need a further $750,000AUD.If results are favorable (we’ll know in about 2-3 years) this may lead to a new form of treatment for patients with mesothelioma.
“While our preclinical research was confined to mesothelioma, we hope this new approach to cancer treatment will also inhibit other tumour types - there is experimental evidence supporting this so the outcomes of this research are eagerly awaited,”
To donate to this world-first clinical trial or for information visit www.adri.org.au or call +61 2 9767 9800.
ASBESTOS DISEASES RESEARCH INSTITUTE (ADRI)
The Asbestos Diseases Research Institute aims to improve the prevention, the diagnosis and treatment of asbestos-related diseases and to provide a better future for all those Australians unfortunately exposed to asbestos.
The Asbestos Diseases Research Institute (ADRI) is the first stand-alone research institute tackling the still increasing epidemic of asbestos-related diseases. The ADRI was established by the Asbestos Diseases Research Foundation, a charitable, not-for-profit foundation. The ADRI is located on the Concord Hospital campus in the Bernie Banton Centre which was officially opened by the Prime Minister, the Hon Kevin Rudd in January 2009.
A small exposure to asbestos can be enough to trigger this cancer, however only a relatively small percentage of people exposed to asbestos develop mesothelioma. There usually is a latency period of around 30- 40 years after first asbestos exposure before mesothelioma is being diagnosed. The disease is currently also diagnosed in young adults incidentally exposed to asbestos fibres as children.
Mesothelioma was a very seldom diagnosis until the 1960’s. According to Safe Work Australia, in 2007, 660 Australians were diagnosed with malignant mesothelioma and experts have estimated that there were at least another 1,350 Australians with lung cancer caused by asbestos. A tragic consequence of highly intensive use of asbestos and its products in Australia in the previous century, it is estimated that these figures will continue to rise in the coming decades.
The prognosis of a patient with mesothelioma is poor and almost all will experience severely debilitating symptoms. Mesothelioma only partially responds to current forms of oncologic therapy and currently there is no curative treatment for the disease. It is therefore critical that we make a substantial investment in medical research to find better means of understanding the specific biology of MM in order to try to achieve better clinical outcomes for people affected by the disease.
TIME FRAME FOR IMPLEMENTATION
Commencement of Phase 0 – I is planned to start by the end of 2013 and is scheduled to run through to the end of 2014.
The objectives for the Phase 0 and I clinical trials are to determine the optimal and safe dose of the experimental TargomiR therapy in a relatively limited number of patients (20-30), with future plans for a Phase II trial.
WHO WILL OVERSEE THE PROJECT?
The project will be overseen by Prof Nico van Zandwijk, Director of the ADRI, as lead investigator, with the assistance of a multidisciplinary team of clinicians at the participating hospitals – see Collaboration with other organisations below.
POTENTIAL POSITIVE OUTCOMES
Malignant pleural mesothelioma almost invariably is a fatal diagnosis and there are few treatment options. Most patients receive palliative chemotherapy, and the last improvement in treatment dates back ten years with the addition of pemetrexed to cisplatin-based therapy. Thus, new curative approaches to therapy remain an urgent need for patients with mesothelioma. Should our clinical trial be successful, there is a good chance that many patients will be eligible for this new form of therapy as almost all tumour (mesothelioma)