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AOP Orphan Planning Phase 3 Trial

Fri, 12/14/2012 - 11:36am

AOP Orphan Pharmaceuticals AG announced that based on promising Phase 2 data it will initiate a Phase 3 trial to support European Marketing Authorization of a novel mono-pegylated Interferon alpha 2b (AOP2014/P1101) for treatment of polycythemia vera (PV).

AOP Orphan has exclusively licensed AOP2014/P1101 for development and commercialization in the field of Myeloproliferative Disorders (MPDs) with the territory of Central Europe, CIS and Middle East from Pharmaessentia Corp. a biotech company based in Taiwan. In contrast to other pegylated Interferons that require weekly administration, AOP2014/P1101 is applied only every other week, resulting in higher convenience and potentially improved tolerability, compliance and long term treatment outcomes.

Results from a Phase 2 trial sponsored and conducted by AOP Orphan were presented at the annual ASH (American Society of Hematology) meeting held in Atlanta.

“Pegylated Interferons represent the most promising treatment modality for patients suffering from MPDs, even providing a chance for cure”, comments Prof. Gisslinger, University Hospital for Internal Medicine I, Hematology, General Hospital Vienna, Austria.

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.

“We are extremely happy with these promising results of AOP2014/P1101, and will take all efforts to make this novel treatment available to patients”, said Dr. Rudolf Widmann, CEO of AOP Orphan.

Based on these results AOP Orphan is initiating a pivotal Phase 2I trial involving Polycythemia Vera patients. The trial termed PROUD-PV will commence early in 2013 and will include centers all across Europe. Design and endpoints of this trial have been discussed between the European Medicines Agency EMA and AOP Oprhan to support a European Marketing Authorization, using EMAs centralized procedure. AOP2014/P1101 has received Orphan Drug designation already in 2011.

Date: December 10, 2012
Source: AOP Orphan Pharmaceuticals AG

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