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news.Aeterna Zentaris, a late-stage drug development company specialised in oncology and endocrine therapy, has received FDA approval for its investigational new drug (IND) application for its doxorubicin targeted conjugate compound, AEZS-108, in luteinizing hormone releasing hormone (LHRH) receptor positive urothelial (bladder) cancer.
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Following the approval from the FDA, Aeterna Zentaris expects to initiate a Phase 2 clinical trial in this indication in the second half of this year.
The study is expected to be conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine with Gustavo Fernandez, 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.
Aeterna Zentaris said that 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, president and CEO of Aeterna Zentaris, said: “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 US, 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.”