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
Pantheon Expands Middle East Presence With New Abu Dhabi Office and Senior Regional Appointment30.9.2026 13:56:00 EEST | Press release
Pantheon, a leading global private markets firm with approximately $84bn in assets under management, today announced the expansion of its presence in the Middle East with the opening of its first office in ADGM, the international financial center based in Abu Dhabi, alongside the appointment of Firas Mallah as Managing Director and Head of Middle East. Demand for access to private equity, infrastructure, and private credit strategies continues to build among sophisticated investors across the Middle East, who recognize Pantheon for its 40-year track record of innovation and expertise across primaries, secondaries and co-investment opportunities. Secondaries – pioneered by Pantheon in 1988 – remains a defining thread across the platform: alongside its long-established private equity secondaries business, Pantheon has among the industry's first and largest private credit and infrastructure secondaries franchises, making it a strong partner in that space across the GCC. These strategies a
34% of Global Consumers Say They Are Worse Off Financially Than a Year Ago as Households Adapt to a New Era of Permanent Uncertainty, NIQ Finds30.9.2026 13:45:00 EEST | Press release
With over a third (34%) of global consumers saying they are financially worse off than they were a year ago, and another third (30%) saying they are financially better off, consumers are no longer waiting for economic conditions to improve. Around the world, households are adapting to a future where volatility remains a persistent reality, creating increasingly different financial outcomes, spending priorities, and pathways to growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930542911/en/ NIQ's Consumer Outlook: Guide to 2027 These findings come from NielsenIQ’s (NYSE: NIQ) latest global Consumer Outlook survey of more than 21,000 respondents across 31 countries, combined with NIQ's measurement of real-world purchasing behavior. The research reveals that economic uncertainty is no longer a temporary disruption, but a defining feature of how consumers make decisions. Findings include: 34% of global consumers globally
Neutrogena ® , Aveeno ® , and Regaine ® Present New Scientific Evidence Demonstrating How Science-Backed Ingredients Support Healthy Skin and Hair30.9.2026 13:45:00 EEST | Press release
Neutrogena®, Aveeno®, and Regaine®* will present 12 new scientific data sets at the 35th European Academy of Dermatology and Venereology (EADV) Congress taking place September 30th through October 3rd in Vienna. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930489298/en/ New Neutrogena science showcased at EADV 2026 in Vienna, Austria Abstracts presented will share new evidence demonstrating how science-backed ingredients including niacinamide, trehalose, colloidal oat and 5% minoxidil can help address some of the most common skin and hair concerns consumers experience, including acne, oily skin, dry skin, hyperpigmentation, eczema, UV-related skin damage and androgenetic alopecia. The findings reinforce a growing body of evidence showing that innovative formulations can deliver benefits beyond traditional expectations by helping protect and strengthen the skin barrier, improve visible skin concerns, and support hair reg
Compass Pathways Appoints Kelley Boucher as Chief People Officer30.9.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced the appointment of Kelley Boucher as Chief People Officer, effective today. This appointment strengthens the Compass executive team as the company continues to scale in support of its mission to bring the first classic psychedelic treatment to the field of psychiatry. In this role, Ms. Boucher will oversee the Company’s people strategy, with an initial focus on guiding its planned evolution towards the launch of COMP360 psilocybin, subject to FDA approval, in the first half of 2027. "We are thrilled to welcome Kelley to our executive team at this pivotal moment in Compass’ journey. As we prepare for our NDA submission in the fourth quarter of this year, we are closer than ever to achieving our goal of introducing an entirely new treatment model in mental health care with COMP360 psilocybin," said Kabir Nath, Chief Executive Officer a
NIQ Expands Google Relationship with Meridian Integration into NIQ Cadence™30.9.2026 13:30:00 EEST | Press release
NIQ (NYSE: NIQ), a leading consumer intelligence company, today announced the expansion of its relationship with Google through the integration of Meridian, Google's open-source MMM framework, into NIQ Cadence™, NIQ's AI-native marketing effectiveness operating system. The strategic partnership gives marketers a single place to measure marketing performance and act on it, shortening the distance between insights and optimization. Marketing leaders are under growing pressure to prove the return on every media dollar, and traditional measurement has struggled to keep pace. In NIQ’s latest CMO Report, 74% of CMOs said they were under more scrutiny to prove marketing ROI, while just 9% felt they had adequate access to real-time insights. NIQ Cadence™ was built to help close the 65-point actionability gap between accountability and timeliness. Rather than treating measurement as a one-time event, the integration brings Meridian into NIQ Cadence™, a unified platform which brings data, models
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