AEterna Zentaris Announces Completion of Phase 1 Study with Oral AEZS-112...(ting GI problems no clinically relevant ...)

"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, AEterna 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."

About the AEZS-112 Phase 1 Study

This open-label, dose-escalation, multi-center, intermittent treatment Phase 1 study included patients with advanced solid tumors and lymphoma who had either failed standard therapy or for whom no standard therapy existed. Patients received a once-a-week oral administration of AEZS-112 for three consecutive weeks, followed by a one-week period without treatment. The cycles were repeated every four weeks based on tolerability and response, basically planned for up to four cycles, but allowing for continuation in case of potential benefit for the patient. The starting dose of AEZS-112 in this study was 13 mg/week, with doubling of doses in subsequent cohorts in the absence of significant toxicity. Primary endpoints of the Phase 1 trial focused on determining the safety and tolerability of AEZS-112 (maximum tolerated dose, MTD), as well as establishing a recommended Phase 2 dose and regimen. Secondary endpoints aimed at establishing the pharmacokinetics and determining the efficacy based on standard response criteria.

Preliminary results from this study were presented recently at the American Association for Cancer Research (AACR) Annual Meeting in Denver, Colorado. Poster #5567 entitled, "Phase I dose-escalation, safety, and pharma
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