EU orphan status recommended for Progen's PI-88

The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending the granting of Orphan Medicinal Product designation for Australian firm Progen Pharmaceuticals' PI-88 in the treatment of hepatocellular carcinoma, or primary liver cancer.

The COMP's opinions are submitted to the European Commission for orphan designation determination, which will become effective upon adoption of this recommendation by the European Commission. This is expected to occur before the end of the third quarter.

PI-88 is part of a new class of multi-targeted cancer therapeutics inhibiting both angiogenesis (or tumor promoting) factors such as vascular endothelial growth factor, fibroblast growth factors 1 and 2, and heparanase, a degrading enzyme implicated in metastasis. Progen will this year launch a multi-national two-armed, double-blinded, placebo-controlled Phase II trial using PI-88, with the primary endpoint of disease free survival, in patients with post-operative primary liver cancer.