Aptose Biosciences (APTO) Updates on APTO-253 FDA Clinical Hold; Says Additional Info Requested Before Removed

October 13, 2016 7:08 AM EDT
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Aptose Biosciences Inc. (NASDAQ: APTO) 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.”

The Company believes its has now developed a drug product that does not cause filter clogging or pump stoppage during simulated infusion studies. The new formulation offers the potential for improved handling characteristics for administration by infusion. Generation of the additional data requested by FDA is underway, and once available the data will be submitted for FDA review, after which time FDA will make a decision on the clinical hold. Enrollment of patients in the trial may resume only following FDA removal of the clinical hold and Investigational Review Board (IRB) approvals at the participating clinical trial sites.

Conference Call and Webcast

Aptose will host a conference call on, Thursday, October 13, 2016 at 8:30 a.m. eastern time. Participants can access the conference call by dialing toll-free (844) 882-7834 (North America toll free number) or (574) 990-9707 (international toll free number), using the conference call passcode 99273697. The conference call can also be accessed at http://edge.media-server.com/m/p/99p9qb4f and will be available through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. An archived version of the webcast along with a transcript will be available on the company's website for 30 days.

An audio replay of the webcast will be available approximately two hours after the conclusion of the call for 7 days by dialing (855) 859-2056, using the passcode 99273697.

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