Progen begins third Phase II trial of cancer drug

Brisbane-based Progen (ASX:PGL) has begun its third Phase II clinical trial in a series of four designed to evaluate the efficacy of its anti-angiogenic drug PI-88 against blood-based and solid tumours, in combination therapy and as a post-surgical treatment.

The new trial, involving 90 patients with advanced non-small cell lung cancer at nine clinical centres around Australia, is designed to evaluate the efficacy and safety of PI-88 in combination with chemotherapeutic drug Taxotere (docetaxel). It is expected to take 12-18 months to complete the study.

A Phase I study conducted at the University of Colorado Health Sciences Centre in the USA was completed this week, providing the safety data and dosing information required to commence the Phase II study.

According to Robert Don, Progen's vice-president of R&D, the trial is modelled on similar trials for other anti-angiogenic drugs, including Avastin, which was tested in combination with chemotherapy in patients with colorectal cancer.

The trial follows a completed Phase II trial looking at the drug as a single agent for treatment of blood cancer multiple myeloma, which was completed last July and showed cancer stabilisation lasting for up to two years in 39 per cent of patients.

A Phase II trial for use of PI-88 as a single-agent therapy for treatment of patients with melanoma started in January, after positive results in Phase I studies were obtained. Progen's managing director Lewis Lee said the commencement of the two Phase II trials marked a significant milestone for the company. But just as importantly, he said, was the message that the company was sending out to investors and potential partners. "In the wider scheme of things it's important for the success of companies in the space to show progress," Lee said.

The company is expecting a fourth clinical trial to begin in the near future. The trial, to look at the efficacy of the drug at preventing tumour regrowth in liver cancer patients who have just had part of their liver removed, will be conducted in Taiwan by Medigen Biotechnology Corporation, who has partnered with Progen for this indication.

Progen plans to use the results of the Phase I and Phase II clinical trials attract a commercialisation partner for PI-88. "We're anticipating moving the partnering activities forward as the trials progress," said business development manager Sarah Meibusch.