The European Medicines Agency’s Committee for Orphan Medicinal Products has recommended granting orphan drug status to Australian group Progen Pharmaceutical’s liver cancer therapy PI-88, and a final decision is now expected by the end of the third quarter.
The drug is part of a novel group of multi-targeted cancer therapeutics that work by inhibiting the formation of new blood vessels to the tumour as well as the action of heparanase, a degrading enzyme believed to play a role in metastasis.
Progen is planning on launching a multi-national Phase III trial in patients with post-operative primary liver cancer later this year, which will assess its ability to reduce disease recurrence, prolong time to recurrence and improve overall survival time of patients after tumour resection.
“While the incidence of primary liver cancer in the European Union is relatively low, with over half a million new cases elsewhere in the world, it is a disease of significant global relevance,” commented Justus Homburg, chief executive of Progen.
PI-88 has received orphan drug designation in the USA for both liver cancer and melanoma, and the group is currently carrying out a Phase II trial in the latter indication, the results of which are expected during the second half of next year.
