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

LONDON, October 12, 2011 /PRNewswire/ --

- Two pivotal trials initiated for treatment of iron deficiency anaemia associated with ulcerative colitis and Crohn's disease -

Shield Therapeutics (Shield), the independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need, today announced that the first patients have been treated in the two Phase 3 clinical studies of ST10 for the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease (IBD).

"Following our successful fundraising in June, we are delighted to have now treated the first patients in the AEGIS Phase 3 programme and we remain on course to have top line results from these studies in late 2012.  Effective treatment of IDA represents a very attractive commercial opportunity and the start of recruitment is an important milestone for Shield Therapeutics as we continue the rapid development of ST10 to address this significant unmet need for the many patients with IDA." said Carl Sterritt, Chief Executive Officer and Co-Founder of Shield Therapeutics.

ST10 is an oral ferric iron-based pharmaceutical that can be administered to patients with improved tolerability compared to currently marketed oral iron treatments and also does not carry the risk of hypersensitivity reactions as is the case with currently marketed intravenous iron therapies.  Whilst prescribers often try oral ferrous products as first line therapy, many subjects prove intolerant and suffer from continuously occurring side effects, exacerbation of inflammatory lesions and failure to correct iron deficiency.  This results in the need for expensive, complicated and invasive intravenous iron therapy.  When treated with ST10, the total dose exposure of unabsorbed iron within the gastrointestinal tract 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 independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need.  Shield is currently conducting two global pivotal Phase 3 studies of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with Ulcerative Colitis and Crohn's disease.

For more information about Shield, please contact:

M:Communications
Emma Thompson / Mary-Jane Elliott
E-mail: shield@mcomgroup.com
Tel: +44(0)20-7920-2342


'/>"/>
SOURCE Shield Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Cord Blood America Enters Agreement With Regence, Serving BlueCross and BlueShield Programs in the Northwest U.S. and Mountain Regions
2. TCT 2009 to Feature vProtect(TM) Luminal Shield, a Novel Treatment Designed for Soft Coronary Lesions from Prescient Medical
3. vProtect(TM) Luminal Shield Stabilizes Life-Threatening Plaque
4. SyntheMed Announces FDA Clearance of SinusShield(TM)
5. NanoVibronix Receives FDA Clearance for its PainShield(TM) MD Device
6. United Therapeutics Announces Proposed Private Offering of $210 Million of Convertible Senior Notes and Authorization of Stock Repurchase Program
7. United Therapeutics Subsidiary Enters Into Contract With National Institutes of Health for Award of up to $45 Million to Support Glycobiology Antiviral Program
8. Kylin Therapeutics Receives Notice of Allowance for Second U.S. Patent Covering Delivery of Therapeutic RNA and pRNAi Technology
9. Orexigen® Therapeutics Announces Multiple Contrave® Data Presentations at the 29th Annual Scientific Meeting of The Obesity Society
10. Halozyme Therapeutics to Present at the JMP Securities Healthcare Conference on September 28
11. ALS Therapy Development Institute and Aestus Therapeutics, Inc., Expand Collaboration on Development of Novel ALS Therapies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... , Mar 29, 2017 Research and Markets ... Analysis & Trends - Industry Forecast to 2025" report to ... ... CAGR of around 7.8% over the next decade to reach approximately ... the market estimates and forecasts for all the given segments on ...
(Date:3/29/2017)... /PRNewswire/ -  GeneNews Limited (TSX:GEN) ("GeneNews" or the "Company") ... risk stratification test for breast cancer, via its ... BreastSentry incorporates a blood-based biomarker test with a sophisticated algorithm ... breast cancer.   ... BreastSentry measures the fasting plasma levels of two ...
(Date:3/28/2017)... ... March 28, 2017 , ... Today, ... Advancement of Science (AAAS), the world's largest general scientific society and publisher ... scholarly collection across its cross-platform reference management system. , All six Science-branded ...
(Date:3/28/2017)... ... 28, 2017 , ... Franz Inc ., the leading supplier of Semantic ... named a ‘Champion’ by Bloor Research in its recent Graph Database Market Update ... and, thanks to Gruff, it was rated as the easiest product to use.” – ...
Breaking Biology Technology:
(Date:3/2/2017)... -- Summary This report provides all the ... its partnering interests and activities since 2010. Download ... Partnering Deals and Alliance since 2010 report provides an ... the world,s leading life sciences companies. On ... inclusion of the most up to date deal and ...
(Date:3/1/2017)... , March 1, 2017  Aware, Inc. (NASDAQ: ... announced that Richard P. Moberg has resigned, ... co-President and Chief Financial Officer and Treasurer of Aware ... to serve as a member of the Board of ... , Aware,s co-Chief Executive Officer and co-President, General Counsel ...
(Date:2/28/2017)... , Spanien, 27. Februar 2017  EyeLock LLC, ... Iris-Scan, wird seine erstklassige biometrische Lösung zur ... 835 mit X16 LTE auf dem Mobile ... März) am Qualcomm-Stand in Halle 3, Stand ... beinhaltet die Sicherheitsplattform Qualcomm Haven™ – eine ...
Breaking Biology News(10 mins):