BRIEF-Aptose submits formal response to clinical hold for APTO-253

Mon Sep 12, 2016 8:16am EDT
 
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Sept 12 (Reuters) - Aptose Biosciences Inc

* During a phase 1b clinical trial with APTO-253, a clinical site experienced stoppage of infusion pump during an iv infusion

* Submitted formal response to U.S. FDA regarding previously announced clinical hold of aptose's phase 1b clinical trial of APTO-253

* Says stoppage of infusion pump during an iv infusion caused by back pressure as a result of clogging of in-line filter

* During a phase 1b clinical trial with APTO-253, a clinical site experienced stoppage of infusion pump during an iv infusion

* Says co provided responses to all of questions cited in clinical hold letter issued by FDA

* Based issue with molecule

* Says now working with a drug product that does not cause filter clogging or pump stoppage

* Now working with drug product that does not cause filter clogging or pump stoppage during mock infusion studies Source text for Eikon: Further company coverage: