FDA grants IND for AEZS-130 Phase 2A trial in cancer cachexia

Nov 28 2011

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Jose M. Garcia, MD, PhD, Assistant Professor, Division of Diabetes Endocrinology and Metabolism, Departments of Medicine and Molecular and Cell Biology, Baylor College of Medicine and Michael I. DeBakey Veterans Administration Medical Center, in Houston Texas, an Investigational New Drug (IND) approval for the initiation of a Phase 2A trial to assess the safety and efficacy of repeated doses of the Company's ghrelin agonist, AEZS-130 (macimorelin), in patients with cancer cachexia. Cachexia, which is 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.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "This trial is further proof of the versatile potential of AEZS-130. Not only are we developing AEZS-130 as a supportive treatment in cancer care, but we are also developing it as the first oral diagnostic test for Adult Growth Hormone Deficiency for which we have already initiated the preparation for an NDA filing in the United States."

Jose M. Garcia, MD, PhD, the principal investigator added, "Weight loss and decreased appetite (cachexia and anorexia) are devastating complications of cancer. However, treatments for this condition are lacking. Ghrelin agonists have the potential of benefiting these patients by virtue of their anabolic and appetite-stimulating properties. The current proposal will explore the safety and efficacy of the novel ghrelin agonist, AEZS-130, in this setting. If effective, this could allow subjects to receive more effective doses of chemotherapy and to have a better functional status. The results generated by the proposed experiments will set the bases for future trials in this and other wasting conditions that also are very prevalent including chronic obstructive pulmonary disease (COPD), renal failure or chronic heart failure (CHF)-induced cachexia."