LACHEN, Switzerland, Nov. 27, 2023 /PRNewswire/ -- New clinical data from Octapharma's hematology portfolio will be presented during the scientific program at the 65th American Society of Hematology (ASH) Meeting & Exhibition, to be held on December 9-12, 2023 in San Diego, California. New data will be presented from the prospective clinical trial using wilate® for prophylaxis in patients with von Willebrand disease (VWD). Additionally, the design of a new Phase IV clinical trial on bone and joint health in people with hemophilia A will be presented, along with updates on research collaborations between Octapharma and academic institutions.
"We are excited to present new data at ASH 2023 that highlight our continued commitment to understanding the mechanisms underlying bleeding disorders and improving standards of care for patients. We are delighted to support clinical and scientific research that advances the care of people with bleeding disorders." – Olaf Walter, member of the board of directors and head of international business units at Octapharma.
The WIL-31 study investigated the efficacy and safety of wilate® prophylaxis in adults and children of either sex with all types of VWD. WIL-31 is the largest prospective prophylaxis study in VWD and the only one with an on-demand prospective run-in study as an intraindividual comparator. The results of the study showed that wilate® prophylaxis is highly effective in reducing the number of bleeds in children and adults and provides compelling evidence to support the use of regular prophylaxis in patients with severe VWD.
Data from subanalyses of the study will be presented at ASH 2023, focusing on the effectiveness of prophylaxis in patients with different types of bleeding and in different patient subsets. Women with bleeding disorders such as VWD are at increased risk for heavy menstrual bleeding, but are underdiagnosed and undertreated. A subanalysis of WIL-31 will be presented demonstrating that prophylaxis with wilate® was effective in reducing the incidence of heavy menstrual bleeding. An additional subanalysis focusing on the efficacy and safety of wilate® prophylaxis in children and adolescents will also be presented.
People with hemophilia A often suffer from joint health problems and reduced bone strength. Prophylaxis with factor VIII replacement therapy has been associated with reductions in rates of joint bleeding, joint deterioration, and degenerative joint disease. In contrast, there is a paucity of data on the long-term effects of prophylaxis with factor-free therapy emicizumab. The new Phase IV PROVE clinical trial aims to evaluate the long-term effects of Nuwiq® or emicizumab prophylaxis on joint and bone health. The study design will be presented for the first time at ASH 2023.
In addition to clinical studies, Octapharma is proud to support scientific research with academic research partners that improves our understanding of different aspects of bleeding disorders. At ASH 2023, the results of various avenues of scientific research will be presented.
In hemophilia A PUPs, the development of FVIII inhibitors is the most important complication of treatment, and there is a need to better understand the mechanisms underlying inhibitor development. The NuProtect with Nuwiq® study was the largest prospective study of a single FVIII product in PUP. Researchers at University College London, UK, will present new data from a substudy of the NuProtect study, revealing differences in gene expression profiles between PUPs that developed inhibitors and those that did not.
In collaboration with the ETH Zurich and Balgrist Campus Zurich, Switzerland, the effect of FVIII on bone remodeling was evaluated in vivo, and the results indicate that FVIII and/or von Willebrand can further inhibit the formation of osteoclasts, cells that play a key role in bone remodeling.
Platelets and endothelial cells play key roles in hemostasis. Research conducted in collaboration with ETH Zurich, Switzerland, and the University of Eastern Piedmont, Italy, revealed significant differences in the binding of different recombinant FVIII products to platelets and endothelial cells.
"We are excited to present additional data from the WIL-31 study, the largest prospective study in VWD, which further supports the use of prophylaxis in children, adolescents and women with von Willebrand disease. We are also proud to present the upcoming PROVE study, that will help us understand how best to protect people with hemophilia A from debilitating joint damage." – Larisa Belyanskaya, head of IBU Haematology.
The posters will be presented at the following times:
Saturday, December 9, 5:30 p.m.-7:30 p.m. (PST)
Póster 1255: Design of a Comparative Study (PROVE) To Assess the Long-Term Effects of Prophylaxis With Simoctocog Alfa or Emicizumab on Joint and Bone Health in Hemophilia A Patients. Autor de la presentación: Robert Klamroth
Póster 1227: Transcriptomic profiling to understand inhibitor development in previously untreated patients with severe hemophilia A. Autor de la presentación: Paul Batty
Póster 1244: Impact of recombinant factor VIII and platelet interaction on platelet functionality and hemophilia A treatment. Autor de la presentación: Fabrizio A. Pennacchio
Monday, December 11, 18:00-20:00 (PST)
Poster 3977: Factor VIII is an endothelial factor that promotes vessel stability. Author of the presentation: Antonia Follenzi
Poster 3979: Inter-donor variability in Osteoclastogenesis and responses to Osteoprotegerin (OPG), von Willebrand Factor (vWF), and Factor VIII (FVIII). Presentation author: Joyce Kimenai
Póster 3992: Efficacy and Safety of Prophylaxis with a Plasma-derived von Willebrand Factor/Factor VIII Concentrate in Children and Adolescents with von Willebrand Disease – A Sub-Analysis of Data from the WIL-31 Study. Autor de la presentación: Robert F. Sidonio, Jr
Póster 3997: Efficacy of Regular Prophylaxis with a Plasma-derived von Willebrand Factor/Factor VIII Concentrate in Reducing Heavy Menstrual Bleeding in Females with von Willebrand Disease. Autor de la presentación: Robert F. Sidonio, Jr
About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the world's largest human protein manufacturers, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products in three therapeutic areas: Immunotherapy, Hematology and Critical Care.
Octapharma has seven R&D centers and five state-of-the-art factories in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers in Europe and the United States. Octapharma has 40 years of experience caring for patients.
Octapharma press releases are specifically directed to the health/medical media and not the consumer press.
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