SAN DIEGO and TORONTO, Oct. 13, 2016 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced that it received a response from the U.S. Food and Drug Administration (FDA) regarding the clinical hold of Aptose’s Phase 1b clinical trial of APTO-253 in patients with hematologic cancers requesting additional information and informing Aptose that the hold would not be removed until this information is submitted and reviewed. The FDA response to Aptose focused exclusively on the request to provide the FDA with complete Chemistry, Manufacturing and Control (CMC) information on the final GMP drug substance and drug product intended for the clinic.
“Data provided to the FDA in our response to their clinical hold questions were collected using prototype batches of API and drug product. As the drug substance was changed from a salt to a free base, and thus modifying the drug product formulation, the FDA has requested additional information on the GMP-grade drug substance and drug product that is proposed for use in the clinic prior to making a decision on the hold and approval for the re-initiation of the clinical trial,” commented William G. Rice, Ph.D., Chairman, President and CEO. “We continue to believe that we are on the correct path to resolve the clinical hold questions. There is an opportunity to create new intellectual property related to the new formulation of APTO-253, a drug that has demonstrated in vitro inhibition of c-Myc expression in AML cells without toxicity to normal bone marrow cells, a powerful differentiator in the treatment of AML.”