AOP Health Presents Final Results From Its CONTINUATION-PV Study - up to 7.5 Years Treatment With BESREMi® (Ropeginterferon alfa-2b) of Polycythaemia Vera Patients - at EHA 2022 Annual Meeting
20.6.2022 12:51:00 EEST | Business Wire | Press release
AOP Health announced the final results on Ropeginterferon alfa-2b in patients with Polycythaemia Vera (PV) from its CONTINUATION-PV study in an oral presentation at the prestigious EHA (European Hematology Association) 2022 Annual Meeting by Professor Heinz Gisslinger, Medical University of Vienna, Austria 1.
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 after stabilization of hematological parameters.
AOP Health has been conducting a pivotal clinical development program, including 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 PV who previously participated in the PROUD-PV study.
The clinical development program conducted by AOP Health in Europe since 2010, led to marketing authorizations of BESREMi® for the treatment of PV, first granted by the European Commission in 2019, thereafter by Switzerland, Liechtenstein, Israel, Taiwan, Korea and most recently by the US FDA in November 2021.
The presentation during the EHA 2022 Annual Meeting focused on patient-relevant outcomes after this long-term (up to 7.5 years) treatment:
Symptoms/Quality of Life: only a minority of patients (15.7%) treated with Ropeginterferon alfa-2b experienced disease related symptoms, and less than 2 out of 10 patients had to undergo phlebotomy to maintain hematocrit levels during their last year of treatment.
Disease modification: Besides that, treatment with Ropeginterferon alfa-2b led to reduction of the disease-causing mutated JAK2 allele burden below 1% in a sizeable proportion of patients (>20%). Most importantly, event-free survival, with events defined as death, thrombosis, or disease progression over the entire 7.5 years treatment period, was significantly better in the Ropeginterferon alfa-2b group with only 5 of 95 patients experiencing an event, whereas in the control group such an event was observed in 12 of 74 patients (p=0.04).
“The results of CONTI-PV after 7.5 years of treatment provide further evidence of the value of BESREMi® for patients suffering from PV. We are very proud that our work not only delivered the first interferon with regulatory approval for any of the Myeloproliferative Neoplasms, but also contributed to a change of treatment paradigm in PV”, says Dr. Christoph Klade, Chief Scientific Officer of AOP Health.
Professor Jean-Jacques Kiladjian from Paris, senior author of the paper adds: “Since its first approval in Europe in 2019, Ropeginterferon alfa-2b has become the first line therapy of choice for many PV patients. The striking JAK2 molecular response and the extremely low rate of disease progression and thrombosis suggest that Ropeginterferon alfa-2b might be the best available treatment option for disease modification, which may translate into improved survival and even the chance to stop treatment for some patients.”
1 Ropeginterferon alpha-2b achieves patient-specific treatment goals in Polycythaemia Vera: final results from the PROUD-PV/CONTINUATION-PV studies. Heinz Gisslinger, Christoph Klade, Pencho Georgiev, Dorota Krochmalczyk, Liana Gercheva-Kyuchukova, Miklos Egyed, Petr Dulicek, Arpad Illes, Halyna Pylypenko, Lylia Sivcheva, Jiří Mayer, Vera Yablokova, Kurt Krejcy, Victoria Empson, Hans C. Hasselbalch, Robert Kralovics, and Jean-Jacques Kiladjian for the PROUD-PV Study Group, European Hematology Association EHA, 27th Annual Meeting June 2022
About BESREMi®
BESREMi® is a long-acting, mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerability. BESREMi® is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or up to monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons.
For the EMA Summary of Product Characteristics please visit : BESREMi®
Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Health. In 2009, AOP Health in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs such as chronic myelogenous leukemia (CML) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
About Polycythaemia Vera
Polycythaemia 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220620005197/en/
Contact information
Mag. Nina Roth, MAS
+43 676 3131509
nina.roth@aop-health.com
AOP Health
Needs. Science. Trust.
AOP Orphan Pharmaceuticals GmbH
Member of the AOP Health Group
Leopold-Ungar-Platz 2, 1190 Vienna, Austria
aop-health.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Taktile Secures $110M in Goldman Sachs-led Series C to Power AI Transformation in Financial Institutions24.6.2026 16:30:00 EEST | Press release
Taktile, the leader in AI transformation for financial institutions, today announced its $110 million Series C fundraise. Growth Equity at Goldman Sachs Alternatives led the round, with participation from Balderton Capital, Index Ventures, Tiger Global, Y Combinator, and Dig Ventures. Taktile Fast Facts Taktile enables banks and insurers to transform into AI-native organizations that are increasingly powered by autonomous agents. Demand for Taktile accelerated in 2025, as AI models became capable of automating high-stakes decisions that previously required hours of manual work—from underwriting business loans and assessing claims to catching financial crime. Customers automate and optimize decisions with Taktile by combining its financial services expertise and product built for sector-specific AI use cases. One of the world’s largest insurers is running multiple use cases on Taktile, with projected cost efficiencies of over $90M in claims processing alone. Taktile’s team has a proven
New MetLife Study Reveals a 72% “Confidence Gap” in Ability to Recover from Life's Setbacks24.6.2026 16:25:00 EEST | Press release
A new multinational study from MetLife reveals a striking “confidence gap”: while most adults describe themselves as resilient, their confidence drops by 72% when faced with real-life setbacks. The Confident Pathways Report, conducted across the United States, United Kingdom, Japan, and Mexico, was designed to better understand how confidence is built and sustained throughout life. The findings underscore the role of opportunity, preparedness, and support in building confidence - factors that help people navigate uncertainty, recover from setbacks and pursue their goals. At a time when soccer is bringing people and communities together around the world, the findings also highlight how early childhood experiences such as sports, education, and mentorship can help foster resilience and gain confidence from a young age. Key findings across the four countries surveyed include: Confidence drops by 72% when adults consider their ability to recover from setbacks. Respondents were far more lik
StatLab Launches CytoPath Disc, Advancing Standardized Cell Block Preparation Worldwide24.6.2026 16:08:00 EEST | Press release
StatLab Medical Products, a leading global developer and manufacturer of pathology supplies and equipment, today announced the global launch of the CytoPath Disc, an innovative cell block preparation technology designed to standardize and simplify cell block preparation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624368623/en/ Developed as an alternative to traditional cell block methods, which convert concentrated cells suspended in fluid into a paraffin-embedded format for slide-based evaluation, the patent‑pending CytoPath Disc offers a more streamlined and efficient approach. The CytoPath Disc absorbs concentrated cells within a simple, sponge-like matrix, which is then processed, embedded, stained, and sectioned using standard histology workflows. Traditional cell block preparation methods often present challenges in achieving consistent results due to complex procedures, as well as the need for additional equipm
TensorX Launches With €8M Seed Funding Round Led by Darius Cubed Ventures for Bet on European Sovereign AI Infrastructure With Plans to Deploy up to €100M in NVIDIA Blackwell GPUs24.6.2026 16:07:00 EEST | Press release
A team of Irish founders has committed €8 million to Nvidia Blackwell GPUs, including the latest B300 chips, to launch TensorX, a sovereign AI inference platform designed for Europe's AI builders, trusted by regulated industries and already generating revenue from paying customers. The company was founded by Shane Morton, is part of the NVIDIA Inception program and is partnering with Dell on sourcing GPU hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528791384/en/ (From left to right): Craig Donnelly, Shane Morton, Nicole Morton, Tim Grant At a time when enterprises are racing to adopt artificial intelligence but most remain unwilling to let their data leave European jurisdiction, TensorX offers high-performance inference with zero data retention, running entirely on dedicated hardware in Dublin and Helsinki. TensorX is also in advanced talks around a financing facility to further expand its European footprint,
Clearwater Analytics Benchmarks Private Credit Strategy, Performance, and Risk Across Institutional Portfolios24.6.2026 16:00:00 EEST | Press release
Clearwater Analytics (NYSE: CWAN) today released Credit Where It’s Due: The Persistent Rise of Private Credit, its first comprehensive study of how private credit has reshaped institutional portfolios. The report draws on holdings and transactions data from the Clearwater platform, which spans $10 trillion in institutional assets across 60 asset classes. It documents private credit exposure, examines how the asset class has contributed to returns, and identifies where investment risks concentrate. The findings challenged a narrative centered on systemic contagion. Instead it found the systemic risks were idiosyncratic, concentrated on specific balance sheets that are largely hidden from investors without the right infrastructure. “At Clearwater, we are no strangers to the rise of private credit. Assets on our platform have grown nearly 20% over the last two years alone,” said Kirat Singh, President of Risk and Alternative Assets at Clearwater Analytics. “This report was born from what
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom