AOP-HEALTH
10.6.2024 13:15:26 CEST | Business Wire | Press release
AOP Orphan Pharmaceuticals GmbH (AOP Health) continues a successful clinical research program in hematology/oncology with two abstracts accepted for presentation at the European Hematology Association (EHA) 2024 hybrid congress in Madrid, Spain. One results in an oral presentation of the latest results from the PROUD-PV and CONTINUATION-PV-trials. The outcomes show a correlation between the changes at genetic level (molecular response) and event-free survival (EFS) among patients with a rare blood cancer (polycythemia vera /PV) who received a certain interferon (ropeginterferon alfa-2b/BESREMi®) or best available treatment.1 A second accepted abstract reports on AOP Health’s recently initiated phase III clinical study extending investigation of ropeginterferon alfa-2b to patients with another rare blood cancer, essential thrombocythemia (ET).2 In a further signal of AOP Health’s commitment to innovative research, early development of a first-in-class investigative oncology drug is progressing towards clinical trials.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610730599/en/
Professor Jean-Jacques Kiladjian, University of Paris, France Photo credit: AOP Health/Lorenz Paulus
Reduction of mutated cells improves event free survival in patients with PV and is effectively achieved by ropeginterferon alfa-2b
The latest findings of the large randomized controlled PROUD-PV trial and its extension CONTINUATION-PV3 showed that ropeginterferon alfa-2b reduced the amount of cells that carried a mutation of a certain gene (JAK2V617F, a gene, which regulates cellular growth) in the patient population studied.3 Analysis of all patients included in the trial over at least 6 years showed significantly prolonged event free survival (period in which patients remain free from events that the treatment was intended to prevent or delay) among patients in which the amount of mutated cells were reduced at the last available assessment.
Professor Jean-Jacques Kiladjian from the University of Paris, France and first author of the paper emphasizes: “This new evidence supports the clinical relevance of reducing the load resulting of JAK2V617F mutations to improve long-term outcomes in patients with PV, which should be considered as an aim of treatment. Ropeginterferon alfa-2b targets mutated blood-forming stem cells and is highly effective in decreasing the burden resulting from the mutation of JAK2V617F gene.”
Phase III clinical study of ropeginterferon alfa-2b in ET underway in Europe
With the aim of examining the potential utility of ropeginterferon alfa-2b in ET patients with significant unmet need, AOP Health has rolled out the ROP-ET trial, a prospective, multicenter, single-arm phase III study to assess the long-term safety and efficacy of ropeginterferon alfa-2b in ET patients unable to receive available cytoreductive therapies.4 The trial is being conducted at 36 sites in 10 countries in Europe. Almost 50 % of the required number of patients have already been enrolled in the study. This fast recruitment underlines the importance of the clinical trial.
New drug candidate: official start of clinical development imminent
Building on proven success in the development of cancer stem cell targeting therapies, AOP Health is expanding into a new area of research with a first-in-class investigational oncology drug candidate. This orally available, highly selective serotonin receptor 1B antagonist was discovered and initially developed by Leukos Biotech based on research performed at the Josep-Carreras Leukemia Research Institute and licensed by AOP Health for further development and commercial rights. SERONCO-1, a phase I, first-in-human trial in patients with solid tumors and lymphomas will be conducted in collaboration with Leukos Biotech at the Vall d’Hebron Institute of Oncology (VHIO) with partial funding from the Spanish Ministry of Science and Innovation through the Public-Private Partnership Program (CPP2021-008715). A subsequent trial in acute myeloid leukemia is expected to commence in 2026.
References
- Kiladjian J-J, Klade C, Georgiev P, et al. JAK2V617F MOLECULAR RESPONSE CORRELATES WITH EVENT-FREE SURVIVAL IN AN EARLY POLYCYTHEMIA VERA POPULATION. 2024. https://library.ehaweb.org/eha/2024/eha2024-congress/422323 Last accessed 27 May 2024.
- Kiladjian J-J, Ferrer Marín F, Al-Ali FK et al. ROP-ET: A PROSPECTIVE PHASE III TRIAL INVESTIGATING THE EFFICACY AND SAFETY OF ROPEGINTERFERON ALFA-2B IN ESSENTIAL THROMBOCYTHEMIA PATIENTS WITH LIMITED TREATMENT OPTIONS. 2024. https://library.ehaweb.org/eha/2024/eha2024-congress/421616. Last accessed 27 May 2024.
- 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 Oct;37(10):2129-32.
- Kiladjian JJ, Marin FF, Al-Ali HK, et al. ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options. Annals of Hematology. 2024 Mar 4:1-2.
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.
Approximately 7800 patients are currently treated or have been treated with BESREMi®.
For the EMA Summary of Product Characteristics please visit: BESREMi®
Link: https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf
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 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.
Needs. Science. Trust.
AOP Orphan Pharmaceuticals GmbH
Member of the AOP Health Group
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/20240610730599/en/
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
Verdict Expected Soon in Klarna’s $8.3 Billion Antitrust Lawsuit Against Google24.2.2026 19:09:00 CET | Press release
PriceRunner v. Google: Sweden’s Largest-Ever Civil Damages Claim Reaches Decision Stage; Klarna Provides Investor Update Klarna Group plc (NYSE: KLAR) announces that the Patent and Market Court of Sweden (Patent- och marknadsdomstolen) is expected to deliver its verdict on April 15, 2026 in the antitrust damages proceedings brought by Klarna’s subsidiary PriceRunner International AB against Google LLC and Google Ireland Limited. The trial, which ran from October 20 to December 19, 2025, concerned PriceRunner’s claim for approximately $8.3 billion in damages — the largest civil damages claim ever filed in a Swedish court. The Case The claim arises from Google’s abuse of dominance in online comparison shopping, as established by the European Commission in a binding 2017 decision and upheld without reservation by the Court of Justice of the European Union in September 2024. PriceRunner alleges that Google systematically demoted competing price comparison services in its search results whi
INRIX Announces New Generation of AI Traffic Products: Helping to Improve Safety, Reduce Congestion, and Enhance Mobility Operations24.2.2026 16:49:00 CET | Press release
New generative AI capabilities, enhanced incident detection, and expanded customer deployments mark a major evolution of the INRIX Traffic product family INRIX, a global leader in transportation data and analytics, today announced a major expansion of its Trafficfamily of products, delivering innovativeAI-driven capabilities to help transportation agencies and logistics organizations move from reactive traffic management to proactive, safety-focused and efficient operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260224267928/en/ INRIX introduces expanded automation, generative AI capabilities, enhanced incident detection, and continuous analytics. Over twenty years ago, INRIX commercialized the first system to use GPS data to create real-time traffic information. In 2019, INRIX launched AI Traffic – the world's first traffic platform to leverage deep learning models and AI to improve the quality and analysis globall
Check Point and ControlPlane Partner to Help Enterprises Securely Scale AI and Accelerate Agentic Innovation24.2.2026 15:30:00 CET | Press release
ControlPlane, a specialist AI Security and DevSecOps consultancy, and Check Point Software Technologies Ltd., a pioneer and global leader in cyber security solutions, today announced a strategic collaboration to help enterprises securely adopt Large Language Models (LLMs) and agentic AI systems at scale. The partnership delivers a comprehensive, regulator-ready security framework designed to reduce risk, protect sensitive data, and enable organizations to move confidently from AI experimentation to production deployment. By combining Check Point’s AI-native threat prevention platform with ControlPlane’s deep expertise in cloud native architectures and DevSecOps, enterprises can operationalize AI securely without slowing innovation. As organizations advance AI initiatives beyond pilots, they face a growing “AI readiness gap.” Emerging threats such as prompt injection, unauthorized access, data leakage, and model misuse introduce risks that traditional security controls were not built to
Clinilabs Establishes EU Headquarters in Basel, Strengthening European Clinical Operations Under New Regional Leadership24.2.2026 15:00:00 CET | Press release
Clinilabs, a leading specialty contract research organization (CRO) focused on central nervous system (CNS) drug and device development, today announced the expansion of its European operations, including the establishment of its European Union headquarters at Switzerland Innovation Park Basel Area, and the appointment of Dr. Anne-Marie Nagy as executive vice president and head of Clinilabs Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260224669284/en/ Dr. Anne-Marie Nagy appointed as Executive Vice President and Head of Clinilabs Europe Switzerland Innovation Park Basel Area is part of Switzerland’s national innovation network and located within the Basel region’s globally recognized life sciences cluster, bringing together biopharma companies, research institutions, and clinical innovation leaders. “Europe is a critical pillar of Clinilabs’ long-term growth strategy,” said Gary K. Zammit, Ph.D., president and chie
Yubico Unveils “YubiNation Partners”: A New Era of Global Channel Partnership to Secure Digital Identities in the Age of AI24.2.2026 15:00:00 CET | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), a modern cybersecurity company and creator of the most secure passkeys, today announced the launch of YubiNation Partners, a new global Channel program designed to unite a community of security experts. In the face of growing AI-driven cyber threats, the program enables partners to become trusted advisors and cultivate a safer digital world for their customers, making identities private and secure. As the average cost of a corporate security breach climbs to $4.4 million*, with phishing remaining a primary attack vector, the industry can no longer rely on passwords alone. In fact, a 2026 Total Economic Impact study from Forrester Consulting commissioned by Yubico, found that by replacing traditional multi-factor authentication (MFA) and one-time passwords (OTP) with YubiKeys, customers achieved a 265% return on investment (ROI). This effectively eliminated phishing and credential-theft risks, reducing an organization’s risk exposure to breach costs fr
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