Æterna Zentaris Announces Completion of Phase 1 Study with Oral AEZS-112 in Cancer
Æterna Zentaris Inc. 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.
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.
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