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AM-Pharma Announces Positive Results of Phase IIa Clinical Trial,with Alkaline Phosphatase For Ulcerative Colitis

essed in various tissues throughout the human body including the kidney and GI tract. AP has been shown to dephosphorylate lipopolysaccharides to a non-toxic form that acts as a partial antagonist on the lipopolysaccharide receptor complex. In addition to lipopolysaccharides, AP can dephosphorylate different other substrates e.g. ATP and through this dephosphorylation interfere with several diseases, including ulcerative colitis, sepsis and acute renal failure.

About Ulcerative Colitis Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease affecting the colon, which usually starts between the age of 15 and 25. UC incidence in the US, Europe and Japan is around 1 million patients. Only around 650,000 of these patients, however, receive medical treatment. Around 20% of UC patients (200,000 patients) have a severe and debilitating form of the disease. Ulcerative colitis usually involves the rectum but may extend proximally to involve a portion of or the entire colon. Until recently, sales of UC drugs were around US$1bn, dominated by 5-ASA drugs, corticosteroids and immunosuppressants. However, with the introduction of the marketed drug Remicade(r), total sales in this market segment have been growing substantially.

About the Truelove-Witts and the Mayo scores The Truelove-Witts (TLW) score measures disease activity composed of 6 variables: number of stools per day; blood in stools; temperature; pulse; haemoglobin; and erythrocyte sedimentation (ESR) rate. Response is defined as a TLW score of less than 10 and by a decrease of 3 points or more. Clinical remission was defined as a TLW score of less than 3, which means 1 or 2 stools per day without blood, absence of fever or tachycardia, a normal haemoglobin or "returning towards normal", a normal ESR or "returning towards normal", and gaining weight.

The Mayo score looks at stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and Physician Global Assessment
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