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Shield Therapeutics Initiates Phase III Trial of ST10-021 in Iron Deficiency Anaemia

24 Aug 2011

Shield Therapeutics (Shield), the independent specialty pharmaceutical company focused on the development and commercialisation of late-stage hospital pharmaceuticals, today announced that the first patients has been treated in a Phase III clinical trial of ST10-021 for the treatment of the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis.

ST10-021 is an oral ferric iron preparation that can be administered to patients with improved tolerability compared to currently marketed oral ferrous iron treatments. The total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced when patients are treated with ST10-021 and, as the iron is retained in its chelated form if not absorbed this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date have provided preliminary evidence for the therapeutic potential of ST10-021 in patients with iron deficiency anamea in inflammatory bowel disease, including ulcerative colitis.

The prospective, multicentre, randomised, double-blind, placebo controlled study with ST10-021 (AEGIS 1) will investigate the potential of ST10-021 as a treatment for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used and will measure patients’ change in haemoglobin concentration from baseline to week 12. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used. Initial results from the trial are expected to be reported in early 2012.

There are currently no curative treatments available for ulcerative colitis and so treatments options are restricted to controlling symptoms, maintaining remission and preventing relapse. Iron deficiency anaemia in ulcerative colitis is a chronically debilitating disorder which has a significant impact on the quality of life of affected patients and as a result, treatment of iron deficiency anaemia is an important aspect of the medical management of ulcerative colitis. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with UC suffer from recurrent anaemia, with hospitalization required in severe cases. Oral ferrous products are often the first line standard therapy for mild to moderate IDA in UC, many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency.

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