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

Published 2016-09-12, 08:16 a/m
© Reuters. BRIEF-Aptose submits formal response to clinical hold for APTO-253
APS
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Sept 12 (Reuters) - Aptose Biosciences Inc APS.TO

* 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: ID:nGNXNDAYDa Further company coverage: APS.TO

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