AOP-HEALTH
20.6.2022 11:53:08 CEST | 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220620005197/en/
Link:
About Business Wire
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
Riskified Named to the CNBC World's Top Fintech Companies 2026 List23.7.2026 14:00:00 CEST | Press release
Payment category recognition marks Riskified's continued presence among the world's leading fintech innovators Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, has been named to CNBC's World's Top Fintech Companies 2026 list, in the Payments category. The list, now in its fourth edition, is produced by CNBC in partnership with Statista Inc., the global statistics and industry ranking firm. It was announced on July 22, 2026, and is available on CNBC's website. This is Riskified's second time making the list. The company previously earned this recognition in 2024, reinforcing its position in the ecommerce fraud and risk intelligence sector and underscoring its ongoing success in empowering businesses to grow revenue and profitability by mitigating risk through its AI-powered platform. CNBC and Statista's ranking covers the top 500 companies across eight fintech segments — Payments, Neobanking, Alternative Financing, Wealth Technology, Digital As
Azafaros Completes Enrollment of Phase 3 (NAVIGATE) Study Evaluating Nizubaglustat for the Treatment of Patients with GM1/GM2 Gangliosidoses23.7.2026 13:00:00 CEST | Press release
NAVIGATE comprises two pivotal Phase 3 studies investigating nizubaglustatRecruitment completed in Phase 3 registrational study in patients with late-infantile and juvenile GM1/GM2 gangliosidosesEnrollment in Niemann-Pick type C disease (NPC) Phase 3 study is ongoingTopline data from GM1/GM2 gangliosidoses Phase 3 study is anticipated in early 2028 Azafaros, a private company building a portfolio of disease-modifying therapeuticsto become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses. “Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases," said Stefano Portolano, Chief Executive Officer at Azafaros. "We are deeply grateful to the patients, caregivers, invest
Francisco Partners Closes $21 Billion Across Flagship and Agility Funds23.7.2026 13:00:00 CEST | Press release
Largest fundraise in the firm’s history brings total capital raised to more than $75 billion Francisco Partners (“FP”), a leading global investment firm that specializes in partnering with technology companies, today announced the closing of $21 billion in capital commitments across its Francisco Partners VIII, L.P. flagship fund and Francisco Partners Agility IV, L.P., its middle-market fund. FP exceeded its initial targets of $14.0 billion and $3.5 billion, respectively. This milestone builds on Francisco Partners' longstanding track record of performance, underscored by its distinction as the only firm to rank among the top three performers in each of the past six HEC-Dow Jones Large Buyout Performance Rankings.* “In our business, long-term success is created through a series of relationships built on years of trust and collaboration," said Dipanjan (“DJ”) Deb, Co-Founder and CEO of Francisco Partners. "We want to thank our investors for their support, our management teams for their
Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days23.7.2026 10:21:00 CEST | Press release
The Prague Folklore Days 2026 was held on July 17 and 18 in the heart of Prague, bringing together 56 international arts groups from Germany, Austria, Slovakia, Spain, the Netherlands, and Poland. Four Taiwanese groups took part: Hildebrand Yu’s ocarina band, the Shi-xian Huqin Orchestra, the Taipei Folk Orchestra, and the Four Strings Ensemble. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722841530/en/ Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days Led by Huang Chun-sin, the official Taiwan representative band featured a diverse lineup of ocarina, erhu, and dance performers. Their program stood out among the European groups with its distinctive character and vivid stage presence. Hildebrand Yu’s ocarina band captivated audiences with warm, uplifting melodies accompanied by the ocarina and ukulele. Yu also performed “Twilight Waltz,” delivering a heartfelt piece of poetic expression, like sunlight
Taiwan Children’s Choirs Garner Major Awards at Hungarian Choral Competition23.7.2026 09:33:00 CEST | Press release
Competing against 36 leading contenders from 20 countries, four Taiwanese children’s choirs have garnered several major awards and top honors at the 5th Budapest International Choral Celebration, showcasing Taiwan’s cultural diversity and music excellence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722613876/en/ Puzangalan Children’s Choir and Yo Wu Wei Children’s Chorus join forces with international choral ensembles and orchestras to perform Mozart’s Requiem Mass in D minor, K. 626 at the Béla Bartók National Concert Hall of Müpa Budapest. With its pure, angelic voices and exceptional vocal techniques, Puzangalan Children’s Choir from Pingtung County won the top prize, Laurea Summa Cum Laude, in the Grand Prix Competition’s Youth Choir of Equal Voices, Folklore, and Sacred Music categories. In the Open Competition, Yo Wu Wei Children’s Chorus claimed three gold prizes in the categories of Youth Choir of Equal Voices
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