Results of Phase 1 study of Oral AEZS-112 announced by Aeterna Zentaris

Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) ("the Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced the completion of a Phase 1 study of its orally-active tubulin and topoisomerase II inhibitor compound, AEZS-112, in patients with advanced solid tumors or lymphoma, which may potentially provide a new therapeutic approach for the treatment of cancer. Under the supervision of lead investigator, Daniel D. Von Hoff, MD, Senior Investigator and Physician in Chief at the Translational Genomics Research Institute in Scottsdale, Arizona, this open-label, dose-escalation, multi-center, intermittent treatment Phase 1 trial was conducted at 2 clinical sites in Scottsdale: the Mayo Clinic with principal investigator Donald W. Northfelt, MD, and at Premiere Oncology with principal investigator David Mendelson, MD.

Results

The study was performed in two parts and included 42 patients overall. In Part I, 22 patients were studied on doses ranging from 13 to 800 mg/week. In Part II, the weekly dose was split into 3 doses taken 8 hours apart, and ultimately, 20 patients received doses from 120 to 600 mg/week. Stable disease with time to failure ranging from 20 to 60+ weeks was achieved in 12 patients with various cancer types, including melanoma and cancers of the colon/rectum, lung, pancreas, prostate, tongue, trachea and thyroid. In several of these patients, the duration of stabilization exceeded the duration of disease control on previous treatment regimens. Except for a dose-limiting gastrointestinal reaction in a patient with pre-existing GI problems, no clinically relevant drug-related adverse events or changes in laboratory safety parameters were observed.

"Prolonged courses of stable disease with minimal to no toxicity are encouraging signs", said Dr. Von Hoff. "The applications for an oral agent with these mechanisms of action are numerous."

Paul Blake, MD, Æterna Zentaris Senior Vice President and Chief Medical Officer added, "We are pleased with these Phase 1 results on AEZS-112, which indicate the potential for safe combination with other anticancer drugs. We now look forward to working on the further development of AEZS-112 in collaboration with our expert investigators."