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BRIEF-Aptose Biosciences says voluntarily suspends clinical dosing of APTO-253 to review drug manufacturing processes and procedures

Published 2015-11-20, 07:40 a/m
© Reuters. BRIEF-Aptose Biosciences says voluntarily suspends clinical dosing of APTO-253 to review drug manufacturing processes and procedures
APS
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Nov 20 (Reuters) - Aptose Biosciences Inc APS.TO :
* Voluntarily suspends clinical dosing of apto-253 to review drug manufacturing
processes and procedures
* Voluntary suspension of dosing by the company was initiated as a result of a
planned preliminary review
* Says finding does not undermine the positive safety profile that apto-253
* Says pump experienced back pressure during IV patient dosing at the point of
the filter
* Hold intended to ensure patient safety on trial and to ensure manufacturing
and dosing procedures consistent with appropriate quality standards
* Says expect some delay in the clinical trial
* No drug-related serious adverse events (saes) have been reported
* Further review found preliminary concerns regarding documentation records of
manufacturing procedures of drug product associated to apto-253

* Source text for Eikon ID:nGNXVEWBJa

* Further company coverage APS.TO

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