OXFORD, England, Nov. 12, 2013 -- (BUSINESS WIRE) -- PsiOxus Therapeutics, Ltd. (PsiOxus) today announced top line positive data from a Phase II clinical trial of MT-102 in cancer-related cachexia. The primary endpoint has been met in the recently completed Phase II multinational, randomized, double blind, placebo controlled clinical trial (also known as the ACT1 study), which was undertaken to examine the effect of MT-102 in patients with cachexia due to underlying stage III and IV colon or lung cancer. The data show that patients treated with MT-102 over a 16 week period have greater weight gain when compared to placebo treated patients, and at the highest dose of MT-102 (10mg twice daily) the difference is statistically significant. The clinical study has thus demonstrated MT-102's ability to halt the cycle of weight loss, weakness and fatigue of cachectic late stage cancer patients.
87 patients with stage III or IV lung cancer or colorectal cancer that also met the criteria for cancer cachexia took part in the 16-week study initiated in April 2011. The data revealed today show that response to a 10mg twice a day dose of MT-102 was statistically better compared to placebo. The median bodyweight over the 16 week treatment period increased in patients treated with MT-102, compared to a decreased median bodyweight in those receiving placebo. The full data from the study will be presented in December at the 7th International Conference of the Society on Sarcopenia, Cachexia and Wasting Disorders (SCWD) Conference in Kobe, Japan.
Stefan Anker, professor of cardiology and cachexia research at the Charité, University Hospital Berlin, Germany, and a member of the PsiOxus Therapeutics Scientific Advisory Board, commented: "Sadly, cachexia is a frequent event that every physician knows about and many patients experience, but there are simply no treatments currently available to prevent or reverse its effects. The new MT-102 data presented by PsiOxus is a positive step towards overcoming this debilitating condition."
Dr. John Beadle, CEO of PsiOxus Therapeutics, elaborated further: "Medical treatments of muscle wasting have historically focused on the diseases that predispose patients to cachexia. Only recently has severe weight loss been recognized as a treatable syndrome in its own right. Cachexia causes anabolic and catabolic imbalance that leads to tissue wasting, which in turn causes up to 40 percent of all cancer deaths. As such, an effective treatment for cachexia is currently an area of unmet need with tremendous market potential.
"MT-102's positive impact on stabilising body weight, body composition and physical performance has previously been demonstrated in preclinical models for both cachexia and sarcopenia (age-related skeletal muscle loss). The outcome of this phase II clinical study now shows similar benefits in humans, making this is a very exciting step towards bringing MT-102 to market for these seriously ill patients."
MT-102 is the dual action Anabolic Catabolic Transforming Agent (ACTA) also known as s-pindolol, which is currently in phase II clinical development for the treatment of cachexia and sarcopenia. It is a small molecule agent administered orally twice daily. Two previous phase I/II clinical studies have been conducted to demonstrate the safety profile of MT-102.
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. In addition to MT-102 PsiOxus is also developing ColoAd1 - 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/II clinical development. The Company is also researching treatments based upon "armed" versions of ColoAd1 as well as 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).
Dr. John Beadle, Chief Executive Officer
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