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AskBio erhält FDA Fast Track Status und MHRA Innovative Passport für Gentherapie-Entwicklungskandidat AB-1005 zur Behandlung von Patienten mit Parkinson-Krankheit

(PresseBox) (Berlin, Deutschland / Research Triangle Park, NC, USA, )


- AB-1005 (AAV2-GDNF), eine in der Entwicklung befindliche Gentherapie wird für die Behandlung der moderaten Parkinson-Krankheit untersucht
- AskBio rekrutiert derzeit Patienten in den Vereinigten Staaten im Rahmen von REGENERATE-PD, einer Phase-II-Studie mit AB-1005
- Die Rekrutierung von Patienten in der Europäischen Union und im Vereinigten Königreich ist für später im Jahr 2024 geplant

Bayer und Asklepios BioPharmaceutical, Inc. (AskBio), ein Gentherapie-Unternehmen und hundertprozentige, unabhängig betriebene Tochtergesellschaft von Bayer, haben heute bekannt gegeben, dass die U.S. Food and Drug Administration (FDA) den Fast-Track-Status für das AB-1005-Programm erteilt hat. Das Programm wurde außerdem mit dem Innovation Passport ausgezeichnet, der Auszeichnung taz svlgkyubcr Mwbzkexxwz- elu Hbkbpxsligolsggo otc Dwqequptbazz (UC YMVB) ntc nxudhcfrms Ntxbgkfpzjho.

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