Three years later the FDA finally lifts its hold on Aptose drug, setting the stage for a return to PhIb
After an almost three-year halt imposed by a clinical hold, Aptose Biosciences can finally resume the Phase Ib trial for its MYC inhibitor.
The San Diego-based biotech $APTO explained today that the clinical hold on the trial of APTO-253 was a consequence of an event related to the infusion procedure, which — a root cause investigation determined — resulted from “chemistry and manufacturing based issues.” All of them have now been incorporated in an amendment to the IND application.
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