On November 12 2010 Progen and Muparfostat (PI-88) licensee Medigen Biotechnology Corporation indicated that they have progressed plans to start a phase III in liver cancer patients with an order for clinical trial material.
In August Medigen lodged a special protocol submission for PI-88 with the US Food and Drug Administration ahead of a new drug administration filing. It is planning a 500-patient study for Muparfostat and has now lodged a purchase order for the trial’s clinical material with wholly owned Progen contract manufacturer PharmaSynth.
In March 2010 Medigen took a worldwide commercialisation licence to PI-88 for all oncology indications. It has committed to kicking off a late-stage clinical trial in liver cancer patients within 12 months.
Late-stage product Muparfostat is a multi-targeted cancer therapeutic which Progen previously took to a phase III clinical trial in early 2008, dosing its first patient in March 2010. After only five months it stopped the trials and halted in-house PI-88 development. This was due to recruitment problems, lack of a big partner and potential competition from Bayer’s Nexavar for treatment of post-operative liver cancer. Progen went on to license PI-88 to a little-known US company in 2009 and brought it back in-house earlier this year only to license it back out to former partner Medigen. A decade ago, Medigen participated in phase II trials of the drug, partly funding mid-stage research.
PI-88 inhibits tumour-promoting factors such as vascular endothelial growth factor, fibroblast growth factors 1 and 2, and heparanase, an enzyme implicated in tumour spread.