QUÉBEC CITY, Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that a first patient has been recruited for a Phase 2A trial with its ghrelin agonist, AEZS-130 in patients with cancer cachexia. The study is conducted under a Cooperative Research and Development Agreement (CRADA) between Aeterna Zentaris and the Michael E. DeBakey Veterans Affairs Medical Center which is funding the study. Cachexia, characterized by diminished appetite and food intake in cancer patients, is defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months.
Jose M. Garcia, MD, PhD, Assistant Professor, Division of Diabetes Endocrinology and Metabolism, Departments of Medicine, Molecular and Cell Biology, the NCI-designated Dan L. Duncan Cancer Center and the Huffington Center on Aging at Baylor College of Medicine and Michael E. DeBakey Veterans Affairs Medical Center, is acting as the Principal Investigator of this trial conducted in Houston, Texas.
Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "This is a key study as it allows us to venture into the field of cancer-cachexia, an indication with high unmet medical needs. Because cachexia is very common among cancer patients, our oral ghrelin agonist, AEZS-130, could represent a novel treatment option for many of the 1.5 million people diagnosed with cancer each year, in the U.S. alone."
The Study
This is a double-blind, randomized, placebo-controlled Phase 2A trial to test the effects of different doses of AEZS-130 in 18 to 26 patients with cancer-cachexia. AEZS-130 will be provided by Aeterna Zentaris. The study will involve 3 sequential groups receiving differing doses of AEZS-130. Each dose group will have 6 patients who will receive AEZS-130 and 2-4 patients who will receive placebo. After analysis of safety and efficacy at each dose level vs. placebo, a decision will be taken either to decrease or increase the dose. For this study, adequate efficacy will be defined as a ≥0.8 kg of body weight gain or a ≥50 ng/mL increase in plasma IGF-1 levels.
The primary objective of the study is to evaluate the safety and efficacy of repeated oral administration of AEZS-130 at different doses daily for 1 week in view of developing a treatment for cachexia. The following parameters will be recorded to assess efficacy during the study: change of body weight, change of IGF-1 plasma levels, and change of quality of life score (Anderson Symptom Assessment Scale, FACIT-F). Other secondary objectives will include food intake, and changes in the following: appetite, muscle strength, energy expenditure, reward from food and functional brain connectivity.
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