Genentech: Dosing to Stop in Phase III Clinical Study of Tominersen
By Stephen Nakrosis
Genentech on Monday said it would discontinue dosing in a Phase
III study of tominersen in manifest Huntington's disease.
The company said it would cease dosing in its Phase III
GENERATION HD1 clinical study of tominersen following a
recommendation from an Independent Data Monitoring Committee.
"The iDMC made its recommendation based on the investigational
therapy's potential benefit/risk profile for study participants,"
Genentech said, adding, "no new or emerging safety signals were
identified for tominersen in the review of the data from this
The company also said it would continue to follow study
participants for safety and clinical outcomes.
"Once full data from the Phase III study are available and
analyzed, Genentech will share learnings and future plans with the
HD community," it said.
"Dosing will be paused in the open-label extension study
(GEN-EXTEND) of tominersen while data are carefully analyzed to
inform next steps on this study," Genentech said.
The company also said its "Phase I PK/PD study (GEN-PEAK) of
tominersen and the observational Genentech and Roche HD Natural
History Study will continue."
Genentech is a member of the Roche Group.
--Write to Stephen Nakrosis at firstname.lastname@example.org
(END) Dow Jones Newswires
March 22, 2021 16:43 ET (20:43 GMT)
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