LACHEN, Switzerland, July 4, 2022 /PRNewswire/ --
Octapharma to present new clinical and scientific data from across Octapharma's haematology and critical care portfolios during the ISTH 2022 Congress Data to be presented in 11 poster presentations and during two Supported Symposia New data from the extensive clinical trial programme with Nuwiq® (simoctocog alfa) to be presented, confirming Nuwiq®'s efficacy and safety profile The latest developments in Octapharma's haematology and critical care portfolios will be presented at the 30th International Society on Thrombosis and Haemostasis (ISTH) Congress on July 9–13, 2022, in London, UK. The data will be featured in eleven poster presentations and two Supported Symposia during this major international meeting. Octapharma is proud to be a Gold Supporter of the ISTH 2022 Congress. Poster presentations at the Congress will include data from the Nuwiq® clinical trial programme, including a pooled analysis of long-term data from clinical trials and the first presentation of the results of the global GENA-99 study of Nuwiq in real-world clinical practice. These studies confirm the proven efficacy and safety profile of Nuwiq® in patients with haemophilia A. The safety and immunogenicity results from the phase I/II study of OCTA101, a recombinant FVIII developed for subcutaneous administration, will also be presented, following the recent decision to terminate the study due to safety concerns. Updates from the clinical development programme with the four-factor prothrombin complex concentrate Octaplex® and the high-purity, double virus inactivated, lyophilized human antithrombin III concentrate Atenativ® will also be provided, demonstrating Octapharma's commitment to clinical research and development in critical care. The following posters will be presented.
Monday July 11, 18:30–19:30
PB0690. Dose optimisation in children with severe haemophilia A on long-term octanate® prophylaxis. Presenting Author: Evgeny Dmitriev PB0559. LEX-210: a phase 3, randomized, double-blinded study of four-factor prothrombin complex concentrate in patients with acute major bleeding on direct oral anticoagulant therapy with factor Xa inhibitorsfactor Xa inhibitors. Presenting Author: Ravi Sarode PB0541. Freeze-dried plasma development and assessment of biochemical quality. Presenting Author: Andrea Heger
VPB0492. LEX-211 (FARES-II): a phase 3, prospective, active-control randomised study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients. Presenting Author: Jeannie Callum
Tuesday July 12, 18:30–19:30
PB1149. Pooled analysis of long-term efficacy and safety of simoctocog alfa in previously treated patients with haemophilia A. Presenting Author: Gita Pezeshki, PB1134. Practical utilisation of Octapharma FVIII concentrates in previously untreated and minimally treated haemophilia A patients entering routine clinical treatment – The Protect-NOW Study. Presenting Author: Susan Halimeh PB1126. Safety and efficacy of simoctocog alfa in patients with haemophilia A in routine clinical practice (GENA-99). Presenting Author: Claire Berger VPB0996. FiiRST-2; a prospective, randomized study of clotting factor concentrates versus standard massive haemorrhage protocol in severely bleeding trauma patients. Presenting Author: Jeannie Callum
"We are excited to share our new data and updates at ISTH," said Olaf Walter, Board Member at Octapharma. "Despite advances in the field, managing emergency bleeding and bleeding disorders still comes with considerable challenges. We are constantly striving to address these challenges head-on and to lessen these patients' burdens to improve their day-to-day lives." New data will also be shared during two Supported Symposia as part of Octapharma's 'Under the Spotlight' series. A Key Factor: Aiming for All-Round Bleed Protection in Haemophilia A Saturday July 9, 11:30–12:45 BST Chair: Dr Georgina Hall, John Radcliffe Hospital, Oxford, UK
The symposium will focus on new clinical and scientific insights into the use of Nuwiq® to improve the lives of people with haemophilia A. The topics include the use of matching-adjusted indirect comparisons to assess the relative clinical impact of personalised prophylaxis with different FVIII products, and the use of combination therapy to manage bleeding in people with haemophilia A undergoing major surgery. Also presented will be new in vitro data on the binding of FVIII to platelets, and the use of novel RNA sequencing methods to help predict the risk for inhibitor development in children treated for the first time with FVIII. Focus on Females: Patient Experience and Novel Treatment Strategies in Bleeding Disorders Tuesday July 12, 13:15–14:30 BST Chair: Dr Veronica Flood, Medical College of Wisconsin, Milwaukee, USA
Women with bleeding disorders face unique challenges; many are left untreated or are diagnosed late, which can increase their bleeding risk and impact quality of life. During the symposium, the distinguished panel will discuss the challenges faced by women and girls with von Willebrand disease and haemophilia A. The speakers will illustrate the need for increased awareness and women-specific clinical data, as well as treatment guidelines to support clinicians in making well-informed treatment decisions for female patients with bleeding disorders. New and ongoing studies with wilate® and Nuwiq® will be presented that aim to improve the management of women with von Willebrand disease or haemophilia A. "We look forward to continuing our efforts in raising awareness around and improving the care for women with bleeding disorders, with the ultimate goal of ensuring that these patients have the ability to receive safe and effective management for their symptoms," commented Larisa Belyanskaya, Head of IBU Haematology at Octapharma. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs around 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 180 plasma donation centres across Europe and the US. Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein1. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor1. Nuwiq® treatment has been assessed in seven completed clinical trials which included 280 patients with severe haemophilia A, of which were 190 previously treated patients (PTPs; 190 individuals) and 90 were previously untreated patients (PUPs) 1. Nuwiq® is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations1. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups1. Nuwiq® Summary of Product Characteristics. wilate® Summary of Product Characteristics. Octapharma press releases are specifically for health specialist/medical media and are not for consumer press. Logo - https://mma.prnewswire.com/media/1802873/Octapharma_Logo.jpg