Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that the FDA has approved the company’s Investigational New Drug (IND) application for its doxorubicin targeted conjugate compound, AEZS-108, in luteinizing hormone releasing hormone (LHRH) receptor positive urothelial (bladder) cancer. Following this approval from the FDA, the company expects to initiate a Phase 2 clinical trial in this indication in the second half of this year.
The study will be conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine with Gustavo Fernandez, M.D., Assistant Professor of Medicine, as the Principal Investigator, and will include up to 64 patients, male and female, with advanced LHRH-receptor positive urothelial (bladder) cancer. The study will be conducted in two parts; the first one will be a dose-finding part in up to 12 patients and then, the chosen dose will be studied for its effect on progression-free survival.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, “We are very pleased with the FDA’s approval and excited about this Phase 2 trial in bladder cancer, since it will be our first with AEZS-108 in the United States, and the first one to include male patients. With this upcoming Phase 2 trial, as well as the current Phase 2 trial in advanced ovarian and endometrial cancer conducted in Europe, for which final results are expected before year-end, AEZS-108 has become a major component of our oncology portfolio.”