DGAP-News: Biotest AG: Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen
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DGAP-News: Biotest AG
/ Key word(s): Research Update
PRESS RELEASE Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen
The prospective, open, multicentre phase I/III study investigated the pharmacokinetic properties, efficacy and safety of fibrinogen concentrate in adults and children with congenital fibrinogen deficiency. With well over 100 bleeding events treated in a total amount of 35 patients of all age groups, the study is currently the largest prospective clinical trial in this indication. The evaluation of the extensive data is currently underway. First results confirm the high expectations regarding efficacy and safety and form the basis for the approval of the fibrinogen concentrate purified from human plasma. "We are very pleased to have reached this important milestone in the development of our fibrinogen concentrate. The final results are expected at the end of the 4th quarter of 2020. In addition to IgG Next Generation, this compound is another product manufactured in the new production facility "Biotest Next Level", explains Dr Andrea Wartenberg-Demand, Vice President Clinical Research and Development. In addition to congenital fibrinogen deficiency, there is the indication of acquired fibrinogen deficiency. Biotest is also testing the fibrinogen concentrate in this indication in the phase III trial called "ADFIRST". Here, the inclusion of the patients continues. The results of both studies are to serve as the basis for the approval of fibrinogen concentrate 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 About Biotest IR contact PR contact Ordinary shares: securities' ID No. 522720; ISIN DE0005227201 Disclaimer
26.05.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | Biotest AG |
Landsteinerstraße 5 | |
63303 Dreieich | |
Germany | |
Phone: | 0 61 03 - 8 01-0 |
Fax: | 0 61 03 - 8 01-150 |
E-mail: | [email protected] |
Internet: | http://www.biotest.de |
ISIN: | DE0005227235, DE0005227201 |
WKN: | 522723, 522720 |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange |
EQS News ID: | 1054823 |
End of News | DGAP News Service |
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1054823 26.05.2020
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