PsiOxus Therapeutics, Ltd. (PsiOxus) announced initiation of a Phase II study of MT-102, a small molecule therapeutic for the treatment of cancer- and age-related wasting. MT-102 is being developed to reverse the effects of cachexia, a wasting disease that accompanies cancer, heart failure, COPD, renal failure, cirrhosis and rheumatoid arthritis, and that is associated with significant morbidity and mortality. MT-102 is also in development for sarcopenia, the age-related loss of muscle mass and strength that affects one in five people by age 60.
This Phase II multinational, randomized, double blind, placebo controlled clinical study of MT-102 is in patients with Stage III or IV lung cancer or colorectal cancer that are also suffering severe weight loss and fatigue. The trial is designed to demonstrate reversal of weight loss following treatment with MT-102 but will also examine improvement in functional ability and quality of life as quantified by a battery of previously validated instruments. The trial will enroll 132 cachectic patients with colorectal and lung cancer in centers in Europe and Asia. The reporting of topline results of the study is expected in 2012.
The human safety profile of MT-102 has been demonstrated in two Phase I/II clinical studies. The preclinical efficacy profile has been demonstrated in both cachexia and sarcopenia. A preclinical model of cancer cachexia found that MT-102 demonstrated superior efficacy relative to other tested agents, including agents in advanced stages of clinical development for cachexia. MT-102 not only significantly improved body weight, muscle mass and fat mass, but it also significantly improved mobility and survival.
"Cachexia is a powerful risk factor for increased morbidity and mortality, so breaking this progressive cycle of weight loss, weakness and fatigue is critical for improving the outcome of many serious diseases, such as cancer," said PsiOxus CEO Dr. John Beadle. "MT-102 is unique in that it reduces muscle breakdown (catabolism) as well as increasing muscle build-up (anabolism). This clinical trial aims to demonstrate this Anabolic Catabolic Transforming activity in the context of late stage cancer patients. We are excited to enter this next phase in clinical development, and look forward to moving MT-102 one step closer to treating these serious diseases."
Cachexia is a direct cause of as much as 40 percent of all cancer patient mortalities. Cachexia causes an anabolic and catabolic imbalance resulting in cell death and tissue wasting. Most research activity to date has focused on pro-anabolic treatment. PsiOxus has chosen to focus its approach on anti-catabolic approaches. MT-102 has both anti-catabolic and pro-anabolic activity referred to as an Anabolic Catabolic Transforming Agent (ACTA) and operates on both of the fundamental mechanisms using a single agent.
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