BioCentury
ARTICLE | Clinical News

APTO-253: Phase Ib hold

October 24, 2016 7:00 AM UTC

Aptose said it received a response from FDA regarding a clinical hold the agency placed last November on its open-label, dose-escalation, U.S. Phase Ib trial of IV APTO-253 in about 45-60 patients. According to Aptose, FDA asked the company to provide complete CMC information on the final drug substance and drug product for clinical use. Aptose hopes to submit the information to FDA by December and restart the trial early next year. The biotech said it had changed the product to a free base from a salt, which the company believes does not cause filter clogging or pump stoppage during simulated infusion studies...