Country for PR: United Kingdom
Contributor: PR Newswire Europe
Monday, July 04 2022 - 20:00
Octapharma shares new data at ISTH 2022 in its mission to meet the challenges faced by people with bleeding disorders
LACHEN, Switzerland, July 4, 2022 /PRNewswire-AsiaNet/--

- Octapharma to present new clinical and scientific data from across 
Octapharma's haematology and critical care portfolios during the ISTH 2022 
- Data to be presented in 11 poster presentations and during two Supported 
- New data from the extensive clinical trial programme with Nuwiq(R) 
(simoctocog alfa) to be presented, confirming Nuwiq(R)'s efficacy and safety 

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(R) 
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(R) 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(R) and the high-purity, double virus 
inactivated, lyophilized human antithrombin III concentrate Atenativ(R) 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(R) prophylaxis. Presenting Author: Evgeny Dmitriev
- PB0672. Safety and pharmacokinetics of a subcutaneous recombinant FVIII 
(OCTA101) in adult patients with severe haemophilia A. Presenting Author: 
Sigurd Knaub
- 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 inhibitors. Presenting Author: Ravi 
- PB0560. Use of heparin-calibrated assays to estimate anti-factor Xa activity 
of factor Xa inhibitors (FXaI): a literature correlation analysis. Presenting 
Author: Ravi Sarode
- PB0716. Prospective, Phase III Study of the Efficacy, Safety, and 
Pharmacokinetics of a Human Antithrombin III Concentrate in Congenital 
Antithrombin Deficiency During Surgery or Childbirth. Presenting Author: 
Cristina Solomon
- 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 

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 
- 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(R) 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(R) and Nuwiq(R) 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.

About 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.

About Nuwiq(R)
Nuwiq(R) (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 protein[1]. 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 factor[1]. Nuwiq(R) 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(R) is 
available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU 
presentations[1]. Nuwiq® is approved for use in the treatment and prophylaxis 
of bleeding in patients with haemophilia A (congenital FVIII deficiency) across 
all age groups[1].

About wilate(R)
wilate(R) is a high-purity human von Willebrand factor/factor VIII (VWF/FVIII) 
concentrate, that undergoes two virus inactivation steps during its 
production.[2] No albumin is added as a stabiliser[2]. The purification 
processes result in a 1:1 ratio of VWF to FVIII that is similar to normal 
plasma[2]. wilate(R) contains a VWF triplet structure and content of large high 
molecular weight multimers similar to normal human plasma[2]. wilate(R) is 
exclusively derived from large pools of human plasma collected in approved 
plasma donation centres[3]. wilate(R) is available in 500 IU and 1000 IU 
presentations. wilate(R) is indicated for the prevention and treatment of 
haemorrhage or surgical bleeding in von Willebrand disease (VWD), when 
desmopressin (DDAVP) alone is ineffective or contra-indicated, and for the 
treatment and prophylaxis of bleeding in patients with haemophilia A 
(congenital factor VIII deficiency)[3].

1. Nuwiq(R) Summary of Product Characteristics.
2. Stadler M et al. Biologicals 2006; 34:281-8.
3. wilate(R)Summary of Product Characteristics.

Octapharma press releases are specifically for health specialist/medical media 
and are not for consumer press. 

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Source: Octapharma