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Aptose Biosciences reports delay in clinical trial of cancer treatment

Last updated: 13:01 20 Nov 2015 GMT, First published: 07:29 20 Nov 2015 GMT

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There have been no drug-related serious adverse events in the trial

Cancer treatment specialist Aptose Biosciences (NASDAQ:APTO, TSE:APS) said its Phase Ib clinical trial of APTO-253 has been put on clinical hold.

The US Food & Drug Administration (FDA) made the decision after the voluntary suspension of dosing by Aptose, with the company signaling it intends to conduct a preliminary review to evaluate manufacturing processes and procedures upon the report of an operational difficulty with an intravenous (IV) infusion pump at a clinical site.

The moratorium of the trial, which was on patients with haematologic cancers, will enable the company to ensure dosing procedures are consistent with the appropriate documented quality standards.

Aptose said 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.

There have been no drug-related serious adverse events (SAEs) reported, Aptose stressed, and the observed pharmacokinetic levels in the patients treated were within the expected range.

"We are disappointed by these events and have engaged an independent third party review. Importantly, this finding does not undermine the positive safety profile that APTO-253 has demonstrated in clinical development, and we remain confident in its potential as a promising therapeutic option for patients with acute myeloid leukaemia and other haematologic malignancies," said William Rice, chairman, president and chief executive officer of Aptose.

"While we expect some delay in the clinical trial, we are committed to ensuring that upon re-initiation of clinical dosing the drug product is of the highest standards. We plan to provide updated timeline guidance as soon as practical," Rice added.

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