AOP Orphan Pharmaceuticals: Positive Phase II Data of Novel Mono-Pegylated Interferon Alpha 2b for Treatment of Polycythemia Vera
AOP Orphan Pharmaceuticals AG (AOP Orphan) announced that based on phase II data it will initiate a phase III trial to support European Marketing Authorization of a novel mono-pegylated Interferon alpha 2b (AOP2014/P1101) for treatment of Polycythemia Vera (PV).
Data from 41 PV patients showed no dose limiting toxicities in a dose range from 50-540 μg given every two weeks, with a side effect profile in line with expectations based on other pegylated Interferons. The overall response rate exceeded 90%, at 12 months of treatment 45-50% of patients showed a complete response based on normalization of hematological parameters. A trend for normalization of spleen size was also observed at this relatively early time point. Importantly, after one year all patients were completely independent from phlebotomies. Furthermore, JAK2 allelic burden was reduced significantly and sustained starting from week 28 of treatment. Molecular responses are regarded as important disease modification with the ultimate potential for cure.
Based on these results AOP Orphan is initiating a pivotal phase III trial involving Polycythemia Vera patients. The trial termed PROUD-PV will commence early in 2013.
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