09.12.11

Early Results from XBiotech’s Clinical Study in Cachexia Hint at Breakthrough Treatment

Since February 2010, XBiotech has been studying the effects of its True Human™ antibody therapy to ameliorate the complications of cachexia in late stage cancer patients at MD Anderson Cancer Center. Under the direction of Dr. David Hui (M.D., M.Sc., F.R.C.P.C.) Assistant Professor, Department of Palliative Care and Rehabilitation Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, the ability for the antibody therapy to treat the dreaded complication of cachexia in cancer patients was evaluated.

Patients were analyzed using state-of-the-art methodologies to determine the effects of treatment with the antibody. Assessments included the use of dual-emission X-ray absorptiometry (DEXA) scans, bioelectrical impedance analysis, indirect calorimetry, nutritional diaries and use of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

The study is ongoing, but an interim analysis of the results has recently been made. Complete results of this analysis will be presented and published elsewhere. In summary, the results have shown evidence of improving lean body mass, nutritional intake, appetite and quality of life in a significant proportion of patients with advanced cancer, despite the hypermetabolic state of these patients at baseline and even in the absence of a tumor response in some patients. The findings also revealed that in 50% of evaluable patients, there was a median increase of 1.4kg in muscle mass.

Mr. John Simard commented on the findings saying, “The results are early. But we could not have expected such findings based on any other drug or treatment strategy in existence today. If these results are supported with further study, we are witnessing the emergence of nothing short of breakthrough in the treatment of cachexia and late stage cancer.”

Cachexia, or wasting, is the progressive loss of skeletal muscle and adipose tissue associated with fatigue and weakness commonly observed in multiple disease states, which include cancer, AIDS, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and chronic renal failure.

Cachexia is associated with significant morbidity and risk for death, due to factors that include skeletal muscle loss, longer time periods of convalescence and elevated infection risks. In 2006, it was estimated that in the United States alone, 5 million were afflicted with cachexia due to cancer or other major diseases listed above.

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