FDA lifts clinical hold on Aptose blood cancer drug trial

Jun 29, 2018

Aptose Biosciences announced that the U.S. FDA has lifted the clinical hold on APTO-253, Aptose’s investigational drug for hematologic cancers.

The phase 1b trial of APTO-253 was placed on clinical hold in November 2015 after problems with an IV infusion pump occurred at a clinical trial site. Ultimately, a root cause investigation determined that the event resulted from chemistry and manufacturing based issues, all of which were incorporated into a Chemistry, Manufacturing and Control (CMC) amendment to the Investigational New Drug application.

According to Aptose, 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

Read the press release