First-in-Class Anabolic Catabolic Transforming Agent Aims to Reverse Effects of Cancer- and Age-Related Wasting
LONDON--(BUSINESS WIRE)--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.
About PsiOxus Therapeutics, Ltd.
PsiOxus Therapeutics, Ltd. (www.psioxus.com) is a development stage biotechnology company using non-traditional approaches to develop novel therapeutics that addresses cancer and other clinically unmet diseases. The Company's lead candidate is MT-102, a dual action Anabolic Catabolic Transforming Agent (ACTA) in phase II clinical development for the treatment of cachexia and sarcopenia. PsiOxus is also developing ColoAd1, an oncolytic virus for the systemic treatment of metastatic cancer. ColoAd1 has demonstrated optimal anti-cancer properties in late pre-clinical development.
The Company is also developing treatments based upon the research phase vaccine platform PolySTAR, which combines recombinant viral vectors with polymers to shield them from the immune system, and the research phase adjuvant and immunotherapeutic platform PolyMAP, which combines polymers with synthetic adjuvants to significantly enhance the effectiveness of vaccines.
PsiOxus is advised by a distinguished Scientific Advisory Board that includes Prof Andrew Coats (Norwich Research Park Professor-at-Large, University of East Anglia), Prof Stefan Anker (Professor of Cardiology and Cachexia Research at Charité Medical School, Berlin and President of the Society on Sarcopenia, Cachexia and Wasting Diseases), Prof Len Seymour (Chair of Gene Medicine at Oxford University and Secretary General of the European Society for Gene and Stem Cell Therapy), and Dr Kerry Fisher (an internationally-recognized specialist in molecular medicine, also of Oxford University).