Azaya Therapeutics, Inc. today announced the initiation of a bioequivalence study of ATI-0918 in patients with ovarian cancer. The test product is ATI-0918 (generic doxorubicin hydrochloride liposome injection). The reference product is doxorubicin hydrochloride (HCl) liposome injection, which is marketed in the United States, Israel and Japan as DOXIL® and in the rest of the world as CAELYX®. The U.S. Food and Drug Administration has approved this study.
"We have been working on this development program of ATI-0918 since 2009 and it is gratifying to finally get the product into the clinic for final testing," said Mike Dwyer, President and CEO of Azaya. "We expect to have the results of this study by mid-year 2013 and file all of the required information and the clinical data for regulatory approval shortly thereafter."
"Since the shortage of DOXIL/CAELYX arose in 2011, we have redoubled our efforts to complete the development program for ATI-0918," continued Dwyer. "Azaya's goal with ATI-0918 is to have it approved as a generic equivalent to DOXIL/CAELYX and offer physicians and patients another reliable source for this important product."