AOP-HEALTH
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
Andersen Global tilføjer tilstedeværelse i Fiji med Howards Lawyers18.1.2025 22:23:00 CET | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Asien og Stillehavsområdet ved en samarbejdsaftale med det førende kommercielle advokatfirma Howards Lawyers i Republikken Fiji. Howards blev grundlagt i 1986 og ledes af Managing Partner William "Wylie" Clarke. Det er en virksomhed med speciale i turisme, bankvirksomhed og infrastruktur. De betjener multinationale virksomheder, statslige enheder, enkeltpersoner med høj nettoværdi og kunder på tværs af offentlige og private sektorer med omfattende juridiske tjenester og ekspertise inden for ledelse, arbejdsret, kommercielle transaktioner, virksomhedsfinansiering, sikkerhedsdokumentation, inddrivelse af gæld, miljølovgivning , byggeri, luftfart, selskabsret og kontraktret. "Fiji fungerer som indgangsport til det sydlige Stillehav og giver uovertrufne muligheder for konnektivitet med virksomheder, der ekspanderer ind i regionen," siger Wylie. "Som et af Fijis veletablerede advokatfirmaer er vi fortsat forpligtet på at levere enestående kundes
Hero MotoSports Team Rally Secures an Impressive 7th Place Overall Finish at Dakar Rally 202517.1.2025 21:31:00 CET | Press release
The Indian Manufacturer Team’s Second-Best Dakar Performance in Nine Years Hero MotoSports Team Rally, the motorsport team of the world’s largest manufacturer of motorcycles and scooters - Hero MotoCorp, has successfully completed the Dakar Rally 2025, reinforcing its position as a formidable force in the world’s toughest rally. The team completed this year’s rally at overall 7th position, registering its second best Dakar performance in nine years, after it finished 2nd overall at the world’s toughest rally last year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250117472643/en/ Hero MotoSports at Dakar Rally Stage 12 (Photo: Business Wire) The team’s young Chilean rider, Nacho Cornejo, delivered a stellar performance, maintaining top-10 standings throughout the rally and securing an overall 7th place finish. Nacho showcased remarkable grit and determination, demonstrating his consistency across the stages. Since Stage 1,
Qualcomm Announces Quarterly Cash Dividend17.1.2025 15:00:00 CET | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.85 per common share, payable on March 27, 2025, to stockholders of record at the close of business on March 6, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Our proven solutions drive transformation across major industries, and our Snapdragon® branded platforms power extraordinary consumer experiences. Building on our nearly 40-year leadership in setting industry standards and creating era-defining technology breakthroughs, we deliver leading edge AI, high-performance, low-power computing, and unrivaled connectivity. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing business, QTL, and the vast majority
Jefferies Clients, Shareholders and Employees Contribute $10 Million to Charities Supporting Los Angeles Wildfire Relief17.1.2025 14:00:00 CET | Press release
Jefferies announced today that it will donate $10 million to charities providing aid for first responders and the people and communities impacted by the wildfires across Los Angeles. The donation includes funds from Jefferies, voluntary contributions from its nearly 6,000 worldwide employees, and proceeds from the firm’s January 16 Doing Good Global Trading Day, which set aside 100% of net global trading commissions for charities. Rich Handler, CEO, and Brian Friedman, President of Jefferies, said: “We are so grateful for how the Jefferies network stepped up to support those in need in Los Angeles. These wildfires have inflicted heartbreaking devastation on communities and so many families, and we hope this donation will help deserving charities provide urgently needed relief.” Organization Charity Description Allocation Los Angeles Fire Department Foundation The LAFD is actively seeking funds to equip LAFD members battling wildfires with tools and supplies. $2,000,000 All Hands and He
SLB Announces Fourth-Quarter and Full-Year 2024 Results, Increases Dividend and Initiates $2.3 billion in Accelerated Share Repurchases17.1.2025 12:50:00 CET | Press release
Fourth-quarter revenue of $9.28 billion increased 1% sequentially and 3% year on year Fourth-quarter GAAP EPS of $0.77 decreased 7% sequentially but was flat year on year Fourth-quarter EPS, excluding charges and credits, of $0.92 increased 3% sequentially and 7% year on year Fourth-quarter net income attributable to SLB of $1.10 billion decreased 8% sequentially and 2% year on year Fourth-quarter adjusted EBITDA of $2.38 billion increased 2% sequentially and 5% year on year Fourth-quarter cash flow from operations was $2.39 billion and free cash flow was $1.63 billion Board approved a 3.6% increase in quarterly cash dividend to $0.285 per share Full-year revenue of $36.29 billion increased 10% year on year Full-year GAAP EPS of $3.11 increased 7% year on year Full-year EPS, excluding charges and credits, of $3.41 increased 14% year on year Full-year net income attributable to SLB of $4.46 billion increased 6% year on year Full-year adjusted EBITDA of $9.07 billion increased 12% year o
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