Clinical trials: Building synergies

Spearheading clinical trials in Victoria is Cancer Trials Australia, a consortium involving four hospitals -- including Austin Health, the Royal Melbourne Hospital, the Peter MacCallum Cancer Centre and Western Hospital -- as well as the Ludwig Institute for Cancer Research and the Walter and Eliza Hall Institute of Medical Research.

The group was founded on the back of the early clinical trials for G-CSF and GM-CSF, immune system-stimulating factors discovered by Prof Don Metcalf and his colleagues at WEHI.

In the 10 years since its formal inception, CTA has grown to be one of the premier early-phase trials groups in the country, says CEO Prof Mark Rosenthal, focusing exclusively on cancer therapeutics. The organisation has unique capabilities offered by its combination of clinical and research skills, access to platform technologies and centralised administration of clinical trials, he says.

CTA has ongoing relationships with the big pharma companies too. Last year the CTA became a preferred site for testing Pharmacia's early-stage oncology drugs. While the takeover of Pharmacia by Pfizer has slowed things down, Rosenthal says high-level discussions with the new management have indicated that there is a commitment to continue the relationship once the details have been worked out.

With established relationships with the pharmaceutical industry, CTA is now targeting the Australian biotech sector. Among its clients is Melbourne company Meditech Research, which is using the CTA to test its HyACT series of cancer therapeutics.

"We love to sit around the table with biotechnology companies to look at pre-clinical results and advise on clinical strategies," Rosenthal says. "We pride ourselves on being upfront and honest about results and prospects for successful drugs."

Despite the focus on early-stage trials, he says, CTA, formerly known as the Centre for Development of Cancer Therapeutics, is involved in many multi-centre trials at the Phase II and III level.

"The ant's pants would be if an Australian company came to us to do Phase I trials, then went on with us to do Phase II and even Phase III [in collaboration with development partners and other trial centres]," Rosenthal says.

Recently, CTA received $4 million out of an $8 million STII grant from the Victorian State government awarded to Clinical Trials Victoria (CTV), an umbrella organisation for clinical trials in the state that includes CTA as a member. The grant has been used to upgrade positron emission tomography (PET) scanning facilities at the Peter Mac and the Austin Hospital, as well as to set up an analytical laboratory facility to support and enhance clinical trials.

The CTA laboratory will be used by both CTA and CTV, and will specialise in performing non-standard assays including ELISAs and assays for biological function including gene expression and activity.

"What we'll do are translational studies, such as looking at the molecular biology of drugs and their effects on target tissues, including intracellular responses," says the CTA laboratory's manager, Dr John Barlow. "No one else in Australia does this."

A bioinformatics program is also being established to track the details of all cancer patients at each site, with plans to expand it for other therapeutic areas down the road. The system should allow patient accrual for clinical trials to occur in a faster and more efficient process, says program manager Dr Tim Williamson.

Down the road, Williamson says, the patient database will be integrated with a tissue bank, and access to proteomics data and other information that will add value to the clinical trials process. "It's all about building synergies," he says.