Progen to collaborate with Sanofi-Aventis on prostate cancer trials

Brisbane cancer drug developer Progen Industries (ASX:PGL, NASDAQ:PGLAF) will expand its phase II clinical trial program into prostate cancer to assess the efficacy and safety of its PI-88 angiogenesis inhibitor in combination with Sanofi-Aventis' chemotherapy agent Taxotere (docetaxel).

The first of 82 patients with androgen-independent prostate cancer -- patients whose condition continued to worsen despite having received hormone therapy -- will commence treatment this week at the Royal North Shore Hospital in Sydney and the Sydney Haematology and Oncology Clinics, with further clinical centres around Australia to be added in coming weeks.

The trial was instigated by clinical investigators involved in Progen's current lung cancer trial which is also investigating combination therapy of PI-88 with Taxotere.

"We haven't pushed the trial onto the investigators - they have actually requested this," said Progen's managing director Lewis Lee.

As such, it is likely that the same trial sites will be used, with the possibility of up to 10 sites being added, said Lee.

Sanofi-Aventis, the world's third largest drugmaker, will be providing two thirds of the funding to the clinical investigators as well as the supply of Taxotere. Progen will be providing the other one third of funding.

"We've been trying to look at funding mechanisms so we can provide depth to our clinical program, but at the same time make sure that we have a realistic approach to the burn rate that we provide those development strategies," said Lee.

Progen will be monitoring trial progress and providing safety reporting under the guidelines of the PI-88 Investigational New Drug application with the US Food and Drug Administration.

PI-88 has two modes of action: it inhibits angiogenesis, the formation of new blood vessels that supply tumours with oxygen and nutrients, and it also corrals metastatic cells inside blood vessels, preventing them from forming new tumours.

The main aim of the trial is to determine whether combination treatment with Taxotere and PI-88 is more effective than single agent treatment with Taxotere alone in patients with androgen-independent prostate cancer.

"We'll be comparing that against the published literature where Taxotere is being used on its own, or in combination with, other therapies," said Lee.

The trial will also be examining optimum dosing of PI-88 when combined with Taxotere, with two dosage regimens being examined, said Lee.

Progen expects recruitment in the trial to be rapid due to the limited availability of approved treatments for patients with advanced androgen-independent prostate cancer.

Taxotere is currently undergoing approval in Australia, so patients can only access the agent if they pay for it themselves which is expensive, said Lee.

"If they enter this trial then they can at least get Taxotere for free, but they also have the potential of optimising the outcome of Taxotere treatment by looking at PI-88 as well," said Lee.

"We're hoping that the recruitment will be positively affected by that particular aspect, availability of the drug in Australia."

Recruitment of patients is expected to take about a year, and the company hopes to have results from the trial by the end of December 2006.

Possible partners for Progen

Progen recently announced that it had appointed US based Burrill & Co to assist in its partnering efforts to bring PI-88 to market.

While Lee said that a big pharmaceutical company is the "default that most people would expect", he also said that is not the only option the company is considering.

"Speciality pharmaceutical companies have a lot more enthusiasm because it means more to them. Big doesn't necessarily mean better," he said.

Progen is looking for companies with capability, cash on hand, and a strategy either focused on oncology, or where oncology is a key element, and a demonstrated capability in this area.

"The most important thing is to consider whether the intent is correct, the capabilities are there, and they actually have a significant reach to do justice to a sophisticated program like the one we're developing here," said Lee.