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

 

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments