Aeterna Zentaris: FDA Grants IND to Investigator at Baylor College of Medicine for Phase 2A Trial with AEZS-130 in Cancer Cachexia

Aeterna Zentaris Inc.

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 (

) 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."