AOP Orphan Pharmaceuticals GmbH (AOP Health) announced the publication of final results on the recently developed interferon therapy, ropeginterferon alfa-2b, in patients with polycythemia vera (PV) in the prestigious journal Leukemia1. The full publication expands on results presented at the Annual Meeting of the European Hematology Association. Results of long-term treatment in the CONTINUATION-PV study provide further evidence of the disease modifying capacity of ropeginterferon alfa-2b in PV.
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Portrait Dr. Rudolf Widmann/ AOP Health Group/ credit: Studio Koekart: Natascha Unkart & Isabelle Köhler (Photo: Business Wire)
“AOP Health has invested in a comprehensive clinical research program for ropeginterferon alfa-2b in PV, which has led to the approval by the health authorities in several countries. We are very proud that our scientific work has contributed to addressing the questions that are important to patients”, says Dr. Rudolf Widman, Founder and Board Member of the AOP Health Group.
Professor Heinz Gisslinger from the Medical University of Vienna, the first author of the paper, adds: “Ropeginterferon alfa-2b is already established as an effective first-line treatment for patients with PV. These new results suggest that its potential should be considered when evaluating treatment options.”
Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to monthly following stabilization of hematological parameters.
AOP Health’s pivotal clinical development program for ropeginterferon alfa-2b includes the studies PEGINVERA, PROUD-PV and CONTINUATION-PV. The latter is an open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT) in patients with high-risk or low-risk PV who previously participated in the randomized, controlled PROUD-PV study.
Clinical research conducted by AOP Health in Europe since 2010 has led to marketing authorization of BESREMi® for the treatment of PV, first granted by the European Commission in 2019, and thereafter by Switzerland, Liechtenstein, Israel, Bahrain, Taiwan, South Korea, Japan and the USA.
1 Gisslinger, H., Klade, C., Georgiev, P. et al. Event-free survival in patients with polycythemia vera treated with ropeginterferon alfa-2b versus best available treatment. Leukemia (2023). https://doi.org/10.1038/s41375-023-02008-6
About Polycythemia Vera
Polycythemia Vera (PV) is a rare cancer of the blood-building stem cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition increases the risk for circulatory disorders such as thrombosis and embolism, its symptoms lead to a reduced quality of life and on the long run may progress to myelofibrosis or transform to leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to blood-building stem cells in the bone marrow with a set of acquired mutations, the most important being a mutant form of JAK2 that make up the malignant clone.
Important PV treatment goals are to achieve healthy blood counts (hematocrit below 45%), improve quality of life and to slow or delay the progression of disease.
About AOP Health
The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as also the healthcare professionals treating them.
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