Protagonist Therapeutics' Clinical Hold on Rusfertide Lifted
October 11 2021 - 7:52AM
Dow Jones News
By Matt Grossman
Protagonist Therapeutics Inc. said Monday that the U.S. Food and
Drug Administration has lifted its clinical hold on rusfertide,
allowing trials using the drug to resume.
The hold had been put in place after a finding that mice used in
a study had developed benign and malignant skin tumors.
"No other unexpected safety signals surfaced" from the review
that followed, Protagonist said.
A Phase 3 study for the drug's use in treating polycthemia vera,
a type of blood cancer, could begin in next year's first quarter,
Protagonist said.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
October 11, 2021 07:37 ET (11:37 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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