The phase III trial, PROUD-PV, will commence early in 2013 and will include centers across Europe.
AOP Orphan has also submitted results from a phase II trial at 2012 annual ASH (American Society of Hematology) meeting held in Atlanta, US.
AOP Orphan has acquired exclusive license to develop and commercialize AOP2014/P1101 to treat Myeloproliferative Disorders (MPDs) in Central Europe, CIS and Middle East from Taiwan-based Pharmaessentia.
The phase II clinical trial, with 41 PV patients, has shown molecular responses, which are regarded as important disease modification with the potential for cure.
AOP Orphan CEO Rudolf Widmann said, "We are extremely happy with these promising results of AOP2014/P1101, and will take all efforts to make this novel treatment available to patients."
PV is a disease of the blood-building cells in the bone marrow mainly resulting in a chronic increase of red blood cells (erythrocytes), leading to adverse impact on blood rheology.