Biotest accelerates fibrinogen phase III study with additional patient group
- First patient of this group treated successfully
- Important milestone for acceleration of the clinical development program for Fibrinogen
- Excellent efficacy and tolerability confirmed
- Results are the basis for the marketing authorization in Europe
Dreieich, 7 April 2021. Biotest AG announces today that the first patient with pseudomyxoma peritonei (PMP) has been treated as part of the ongoing phase III trial for the treatment of severe bleeding in the case of acquired fibrinogen deficiency (AdFIrst study no. 995). PMP is a rare malignant and painful tumor in the abdominal cavity. During a surgical procedure, the tumor tissue is removed, which could lead to high blood loss and thus to the loss of the body's own fibrinogen. In order to compensate the fibrinogen deficiency and to effectively stop bleeding, Biotest has developed the fibrinogen concentrate BT524. The efficacy and tolerability of BT524 are investigated in the AdFIrst study (Adjusted Fibrinogen Replacement Strategy) in comparison to the standard therapy, consisting of blood plasma preparations (frozen fresh plasma and cryoprecipitate).
The AdFIrst study is a prospective, randomized, active-controlled, multicenter phase III study that investigates the efficacy and tolerability of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency. Patients who have a high level of blood loss during a planned spinal or abdominal surgery are included.
With the AdFIrst study in acquired fibrinogen deficiency, Biotest is further expanding its development program for the fibrinogen concentrate BT524. The phase I/III study no. 984 for the treatment of patients with congenital fibrinogen deficiency was already completed successfully in May 2020. The results of both studies will serve as the basis for the marketing authorization of fibrinogen concentrate BT524 for the treatment of patients with congenital and acquired fibrinogen deficiency.
About Biotest's fibrinogen concentrate
The newly developed manufacturing process of the fibrinogen concentrate leads to high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility.
About study no. 995 /
The AdFIrst study is a prospective, active-controlled, multicentre phase III study investigating the efficacy and safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency. Patients who have high blood loss during planned spinal and abdominal surgery are randomised 1:1 to treatment with BT524 or FFP/Cryoprecipitate. To evaluate the efficacy, further blood loss is compared between the both treatment options. Further information about the study design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20).
About fibrinogen and fibrinogen deficiency
Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood's ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. To date, these patients have been treated mainly with fresh frozen plasma (FFP), but this contains variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate now allows a tailor-made, patient specific and highly effective therapy.
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
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This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
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