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Premye-an-imen Etid Terapi Gene nan Teknoloji vektè kapsid AAVhu37 nan emofili grav A - BAY 2599023 gen elijibilite pasyan laj ak ki estab ak soutni alontèm ekspresyon de FVIII
Pwen esansyèl ki soti nan reyinyon 62th ASH Anyèl ak Ekspozisyon an

Premye-an-imen Etid Terapi Gene nan Teknoloji vektè kapsid AAVhu37 nan emofili grav A - BAY 2599023 gen elijibilite pasyan laj ak ki estab ak soutni alontèm ekspresyon de FVIII

Steven W. Pipe, MD1, Francesca Ferrante, MD2, Muriel Reis3, Sara Wiegmann4, Claudia Lange5, Manuela Braun5, ak Lisa A. Michaels6

1Depatman Pedyatri ak Patoloji, University of Michigan, Ann Arbor, MI

2Bayer, Basel, Swis

3Bayer, Sao Paulo, Brezil

4Bayer, Wuppertal, Almay

5Bayer, Bèlen, Almay

6Bayer, Whippany, NJ

Kle Done Pwen

Imaj

Nan yon faz kontinyèl 1/2, louvri-etikèt, etid dòz-jwenn, pasyan ki kalifye yo te enskri sekans nan twa kòwòt dòz (0.5, 1, ak 2 x 1013 gc / kg) yo resevwa yon sèl perfusion nan venn nan BAY 2599023, avèk yon minimòm de pasyan pou chak dòz. Pasyan yo pral swiv pou yon total 5 ane pou evalye sekirite ak efikasite.

Imaj

Figi sa a rezime repons lan FVIII (lè l sèvi avèk tès la chromogenic) pou pasyan k ap resevwa yon perfusion sèl nan BAY 2599023 jiska koupe done yo nan 26 Oktòb 2020. 6 pasyan an dòz nan 3 kòwòt yo te montre dòz-depann, soutni ekspresyon FVIII sou 40 –80 semèn swivi.

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Sipòte pa sibvansyon edikasyon bay Bayer, BioMarin, CSL Behring, Freeline Therapeutics Limited, Pfizer Inc., Spark Therapeutics, ak uniQure, Inc.

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