Das George-Huntington-Institut

Roche Studie Generation-HD1 stoppt weitere Dosierung

Die Firma Roche hat in einer Pressemeldung mitgeteilt, dass die Generation-HD1 Studie mit dem Antisense-Oligonukleotid (ASO) Tominersen zwar fortgeführt wird, aber ohne weitere Behandlung mit Tominersen. Eine vorab geplante Statusanalyse des DSMB (Data Safety Monitoring Boards) der Studie hat zwar keine neuen Risiken der Behandlung gezeigt, aber offensichtlich in der Abwägung der möglichen Nutzen oder Risiken zu der Entscheidung geführt, die Behandlung abzubrechen. Alle Studienteilnehmer werden trotzdem eingeladen zu den geplanten Studienvisiten weiter ans GHI zu kommen. 

Weitere Informationen finden sich auf HD-BUZZ (https://de.hdbuzz.net/300)

 

Pressemitteilung von Roche (https://www.roche.com/media/releases/med-cor-2021-03-22b.htm):

  • Dosing to stop in Phase III clinical study of tominersen following recommendation from an Independent Data Monitoring Committee (iDMC)

  • No new safety signals were identified for tominersen in the iDMC’s review

"Basel, 22 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). The iDMC made its recommendation based on the investigational therapy’s potential benefit/risk profile for study participants. No new or emerging safety signals were identified for tominersen in the review of the data from this study. Roche intends to continue following participants for safety and clinical outcomes, without the dosing of the investigational medicine or placebo. Once full data from the Phase III study are available and analysed, Roche will share learnings and future plans with the HD community.

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