By Matt Grossman
Protagonist Therapeutics Inc.'s clinical studies for its rusfertide drug have been placed on a clinical hold by the U.S. Food and Drug Administration because of a recent finding in a mouse-model study, the company said Friday.
Benign and malignant skin tumors were observed in the mouse-model study, Protagonist said.
Dosing of patients has been put on hold, the Newark, Calif.-based pharmaceutical company said. Rusfertide was being tested in three Phase 2 trials, to treat polycthemia vera--a type of blood caner--and hereditary hemochromatosis, or iron overload.
Protagonist said it will work with the FDA to make any necessary updates to study protocols.
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(END) Dow Jones Newswires