Progen and Quintiles enter drug development accord

Australian biotechnology firm Progen Pharmaceuticals has executed an agreement with US pharmaceutical services organization Quintiles, which will see the latter provide services for a range of the former's drug development projects. Key among these will be the execution, before the end of the year, of a Phase III clinical trial of Progen's developmental agent PI-88 in the treatment of hepatocellular carcinoma.

Progen explained that the Phase III PI-88 trial's primary endpoint is the duration of disease-free survival of patients who have undergone surgery to remove cancerous liver tumors. Justus Homburg, the firm's chief executive, said that, "since the middle of last year, we have been working with external advisors, including Quintiles and the US Food and Drug Administration to develop [Progen's] Phase III trial." He added that the company was aggressively pursuing the study's initiation and would continue its discussions with the FDA regarding the ongoing Special Protocol Assessment process.