PSI CRO And AOP Orphan Launch Phase 3 Trial In Rare Disease

PSI Contract Research Organization (PSI CRO) together with its partner AOP Orphan Pharmaceuticals announced the start of a new global study in rare disease Polycythemia Vera (PV).

The new project will enroll 100 patients with PV in an open label, multicenter study to be held at 45 sites across 13 nations worldwide. The new collaboration stems from a previous successful partnership of PSI and AOP in an earlier Phase III study of more than 250 patients in Polycythemia vera.

PV is a rare disease affecting the blood-producing cells in the bone marrow. The disease is characterized by a chronic excess of red blood cells which negatively impacts blood flow and rheology. PV may cause thrombosis or embolism. The disease may also lead to myelofibrosis or leukemia. When properly treated, patients with PV can achieve near-normal life expectancy.

Along with the PV trial, PSI also launched recruitment of patients with metastatic non-small cell lung cancer (NSCLC) and completed the active treatment period in a Phase III study investigating a novel antineoplastic. Enrollment for a Phase II study in patients with chronic obstructive pulmonary disease (COPD) was also completed. PSI reported recent completion of a Phase I study investigating a new biological agent in patients with hemophilia A.

The company recently appointed key members in its executive team, namely Dr. Gabriele Schmoetzer as head of its regulatory affairs in Germany and Jim Kostka as Director of Project Management in its North America operations.

AOP Orphan is an Austrian company centered on clinical research development and supply of drugs for rare and complex diseases. The company announced a recent collaboration with Ferrer Internacional for the commercialization of the anti-psychotic drug Adasuve (Staccato Loxapine) in Central and Eastern EU. AOP also signed up international pharmaceutical expert Hans Peter Hasler to its supervisory board.