Aptose Biosciences Voluntarily Suspends Dosing in Cancer Drug Trial

Aptose Biosciences (NASDAQ:APTO) (TSX:APS) has voluntarily suspended clinical dosing in its cancer drug trial.
According to the press release:

The Food and Drug Administration, following a voluntary suspension of dosing by Aptose Biosciences Inc. and discussions with the company, has placed the phase Ib clinical trial of APTO-253 in patients with hematologic cancers on clinical hold. This hold is intended to ensure patient safety on the trial, and to ensure manufacturing and dosing procedures are consistent with the appropriate documented quality standards.
The voluntary suspension of dosing by the company was initiated as a result of a planned preliminary review, which was accelerated to evaluate manufacturing processes and procedures upon the report of an operational difficulty with an IV infusion pump at a clinical site. The pump experienced back pressure during IV patient dosing at the point of the filter. Further review discovered preliminary concerns regarding the documentation records of the manufacturing procedures of the drug product associated with APTO-253.
The company stated that a complete safety review of all patient files had been completed prior to initial discovery of the manufacturing documentation irregularities, and there have been no drug-related serious adverse events (SAEs) reported. The observed pharmacokinetic levels in the patients treated were within the expected range.

Click here to read the full press release.