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Shield Therapeutics Initiates AEGIS 1 and AEGIS 2 Phase 3 Studies of ST10
Date:10/11/2011

act is significantly reduced and, as the iron is retained within the product if it is not absorbed, it is expected this will significantly reduce the risk of unwanted side effects within the gastrointestinal tract.

The international, multicentre, randomised, double-blind and placebo controlled AEGIS 1 and AEGIS 2 studies will investigate the potential of ST10 as a twice-daily treatment of IDA in subjects with Ulcerative Colitis (UC) or Crohn's disease respectively where oral ferrous preparations have failed or cannot be used.  The studies are each enrolling 120 patients and will measure patients' change in haemoglobin concentration from baseline to week 12.  Initial results from both studies are expected to be reported in late 2012 and, if positive, will be promptly followed by filings of marketing authorisation applications in key pharmaceutical markets.  In addition, Shield is planning to initiate a Phase 3 study of ST10 for the treatment of IDA in patients with chronic kidney disease in 2012.  

Data provided by IMS suggests that the iron market was worth $2.4 billion in 2010, of which 55% of revenues were generated from oral iron therapies.

There are currently no curative treatments available for UC or Crohn's and so treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse.  IDA in both is a chronically debilitating disorder which has a significant impact on patients' quality of life and, as a result, its treatment is an important aspect of disease management.  Characteristic symptoms of IDA include chronic fatigue, headache and subtle impairment of cognitive function.  Up to one third of subjects with UC and Crohn's suffer from recurrent anaemia, with hospitalisation required in severe cases.

About Shield Therapeutics

Shield Therapeutics (http://www.shieldtherapeutics.com), founded in 2008, is an ind
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