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ARTICLE | Clinical News

FDA lifts hold on Aptose blood cancer candidate

July 13, 2018 7:54 PM UTC

Aptose Biosciences Inc. (TSX:APS; NASDAQ:APTO) said FDA lifted a two-and-a-half year clinical hold on a Phase Ib trial evaluating IV APTO-253 in patients with hematologic malignancies.

In 2015, FDA placed a hold on the open-label, dose-escalation, U.S. trial after an IV infusion pump clogged during patient dosing at a clinical site. Aptose said the root cause of the event was determined to be chemistry- and manufacturing-based issues. The company manufactured a new batch of GMP-grade APTO-253 drug substance and conducted studies to demonstrate the fitness of the drug product for clinical use...

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Aptose Biosciences Inc.