New trial for Progen melanoma therapy

Queensland oncology drug-discovery company Progen Industries (ASX:PGL, NASDAQ: PGLAF) has begun a new Phase I/II clinical study of its lead anti-cancer compound PI-88 in patients with malignant melanoma.

The multi-centre trial will involve the University of Colorado Health Sciences Centre (CHSC) in Denver, Colorado, which recently completed a PI-88 dose-ranging trial in melanoma patients with advanced secondary tumours, and four Australian hospitals -- the Sir Charles Gairdner Hospital in Perth, the Princess Alexandra in Brisbane, Melbourne's Alfred Hospital, and the Queen Elizabeth Hospital in Adelaide.

Malignant melanoma is one of the most rapidly lethal of all cancers, and the CHSC trial involved patients with end-stage melanoma whose tumours are no longer surgically treatable, and have ceased respond to conventional chemotherapy and radiation therapy.

The Denver centre specialises in trialling promising cancer therapeutic in patients with end-stage cancer; their prognosis is poor and mortality rates are usually high. Yet 40 per cent of the 42 patients treated wth PI-88 in the CHSC trial are still alive, prompting a doctor supervising the trial to describe the Australian prototype drug as "an unprecedented success".

The first patient to join the dose-ranging trial is still alive 30 months after beginning the therapy, and leading a normal life. Progen's business development manager, Sarah Meibush, said today the man was back at work, and works out at a gym -- his secondary tumours have actually regressed. Two other patients are still alive more than 24 months after entering the trial; their tumours are also said to have also regressed or stabilised.

PI-88 is a powerful inhibitor of angiogenesis, the formation of new blood vessels that supply vigorously growing tumours with oxygen and nutrients.

Developed by Dr Chris Parish, of the John Curtin School of Medical Research in Canberra, PI88 is also believed to limit the spread of cancerous cells around the body by confining them to blood vessels.

"The interesting thing is that the patients in the first trial were on doses ranging from 80 to 315 milligrams per treatment," Meibusch said. "We were only looking to see if the drug was well tolerated, not whether it could cause tumours to stabilise or regress.

"In the new Phase II trial, the dose will be optimised at 250 milligrams. Because there will be no low-dose patients, we hope the results will be even better."

The new trial is the first of three new Phase II trials planned by Progen. Another will test PI-88 in combination with the commercial cancer drug Taxotere as a second-line therapy in patients with advanced, non-small cell lung cancer, while the third, to be conducted by Taiwan's Medigen Biotechnology Corp, will trial PI-88 as an adjuvant therapy to prevent secondary cancers in post-operative liver-cancer patients.

Melanoma, the deadliest form of skin cancer, is rising at a rate of 4 per cent a year in the US, where nearly 54,000 cases of malignant melanoma were diagnosed in 2002.

In Australia, malignant melanoma claims about 1000 lives a year in Australia, which has the highest rate of skin cancer in the world.