(Chemotherapy Advisor) – A new drug developed by Æterna Zentaris, Inc. (Quebec City, Canada) might begin to ease the impact cancer cachexia has on the cancer patient’s quality of life. Cancer cachexia, a complex metabolic syndrome characterized by diminished appetite and food intake, leads to at least a 5% decrease in pre-illness weight and is generally associated with a poor prognosis.
Ghrelin is a natural appetite stimulator found in the body, and Æterna Zentaris has used this biology to develop AEZS-130, a ghrelin agonist and novel small-molecule that stimulates appetite by increasing the secretion of growth hormone after binding to the ghrelin receptor. There are currently no approved treatments for cancer cachexia, and off-label treatments such as appetite stimulants are ineffective and have safety issues.
Æterna Zentaris is currently collaborating with the Michael E. DeBakey Veterans Affairs Medical Center (Houston, Texas) to initiate a Phase 2a trial to assess the safety and efficacy of repeated doses of AEZS-130. The double-blind, randomized, placebo-controlled study will test the drug in 18 to 26 patients with cancer cachexia. Initial dosing will be followed by analysis of safety and efficacy data for that dose level, which will then inform a decision to increase or decrease the dose. The dosing protocol will then continue at the new dose level.
The primary outcome measures will be change in body weight, change in IGF-1 plasma levels, and change in quality of life score. Secondary primary outcome measures will include food intake, as well as changes in appetite, muscle strength, energy expenditure, and more.
For more information from Æterna Zentaris: