DGAP-News: Biotest AG
/ Key word(s): Study
07.04.2021 / 07:00
The issuer is solely responsible for the content of this announcement.
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 2020. 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
About study no. 995 /
About fibrinogen and fibrinogen deficiency
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
|Phone:||0 61 03 – 8 01-0|
|Fax:||0 61 03 – 8 01-150|
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange|
|EQS News ID:||1181473|
|End of News||DGAP News Service|