PsiOxus Therapeutics Completes Patient Enrollment for Phase II Wasting Disease Therapeutic MT-102

OXFORD, England --(Business Wire)--

PsiOxus Therapeutics, Ltd. (PsiOxus), 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. The agent's unique dual mode of action, which has both anti-catabolic and pro-anabolic activity, directly impacts two of the principle pathophysiological hallmarks of cachexia and has been shown to have beneficial effects upon both cachexia and age-related sarcopenia in vivo.

Cancer cachexia is a wasting syndrome characterized by loss of muscle and fat, and occurs in the majority of patients with advanced, refractory malignancies. The disease accompanies a wide range of serious illnesses including cancer, heart failure, COPD, renal failure, cirrhosis and rheumatoid arthritis and is associated with significant morbidity and mortality. Sarcopenia is the loss of muscle mass and function that results from the process of aging.

"Cachexia is a very serious, but often underestimated and poorly managed medical consequence of cancer," said Dr. John Beadle, CEO of PsiOxus Therapeutics. "Historically, treatment has focused on the underlying illnesses that predispose patients to cachexia, and it is nly very recently that cachexia has been regarded as a treatable syndrome in its own right. There is thus a significant unmet medical need with tremendous market potential for an approved, effective treatment for these patients. Our lead compound MT-102 is a very promising mode of treatment that has shown to have a positive impact on weight change, body composition and physical performance in pre-clinical models. Completion of recruitment in this clinical study is the next critical step in assessing the compound's effectiveness to help fight these wide-spread diseases."

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.

About PsiOxus Therapeutics, Ltd.

PsiOxus Therapeutics is an Oxford, UK-based development stage biotechnology company using non-traditional approaches to develop novel therapeutics that address cancer and other clinically unmet diseases. ColoAd1 is an oncolytic vaccine for the systemic treatment of metastatic cancer, which has demonstrated exceptional anti-cancer properties in late pre-clinical development and is now in phase I clinical development. MT-102 is a dual action Anabolic Catabolic Transforming Agent (ACTA) in phase II clinical development for the treatment of cachexia and sarcopenia. 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.

Dr. John Beadle is CEO of PsiOxus. Dr. Beadle was previously a co-founder of PowderMed, which was sold to Pfizer, Inc. for more than $300 million in 2006. Dr. Michael Moore, the former CEO of Piramed, which was acquired by Roche in 2008, serves as Chairman of the Board of Directors.

PsiOxus is advised by a distinguished Scientific Advisory Board that includes 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 Andrew Coats (Norwich Research Park Professor-at-Large, University of East Anglia), 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).