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Clinical Trials

Date: 2013-03-04

Type of information:

phase: 2

Announcement:

completion of patient enrollment

Company: PsiOxus Therapeutics (UK)

Product: MT-102

Action mechanism:

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.

Disease: cachexia

Therapeutic area:

Country: Europe, Asia

Trial details: This Phase II multinational, randomized, double blind, placebo controlled clinical study of MT-102 has enrolled 87 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.

Latest news: * On March 4, 2013, PsiOxus Therapeutics, a development stage biotechnology company, has completed patient enrollment for its Phase II clinical trial to study MT-102, a small molecule therapeutic for the treatment of cancer cachexia. This Phase II multinational, randomized, double blind, placebo controlled clinical study of MT-102 has enrolled 87 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 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. MT-102 not only significantly improved body weight, muscle mass, fat mass and mobility, but it also significantly improved survival.
* On March 17, 2011, PsiOxus has 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.

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.

Is general: Yes