Aptose Biosciences Inc (APTO)

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Aptose Says FDA Lifts Clinical Hold on Cancer Drug >APTO
7:21 am ET June 29, 2018 (Dow Jones) Print
By Colin Kellaher

Aptose Biosciences Inc. (APTO, APS.T) on Friday said the Food and Drug Administration lifted a clinical hold on APTO-253, allowing the investigational drug for hematologic cancers to return to its Phase 1b trial.

The trial was placed on clinical hold in 2015 after an event that occurred at a clinical site with an infusion procedure. Aptose said an investigation determined the event resulted from chemistry and manufacturing-based issues, which the company said were incorporated into an amendment to its Investigational New Drug application.

The Toronto-based oncology company said APTO-253 is the only known clinical-stage molecule that has the potential to directly inhibit expression of the MYC oncogene, shown to be a causative factor in many malignancies, including acute myeloid leukemia.

Aptose said up to 15 clinical centers will participate in the Phase 1b trial, with screening and dosing to resume as soon as practicable for patients with relapsed or refractory AML or with high-risk myelodysplastic syndromes.

Trading in Aptose shares was halted premarket Friday.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

June 29, 2018 07:21 ET (11:21 GMT)

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