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:2/24/2017)... FRANCISCO , Feb. 24, 2017 Symic ... is developing a new category of therapeutics, announced today ... of SB-030 in peripheral artery disease. The trial will ... administered single-use therapeutic, in the reduction of restenosis following ... this critical development milestone for SB-030," said Nathan ...
(Date:2/24/2017)... ... February 24, 2017 , ... FireflySci, Inc is an explosive small ... FireflySci had the goal of bringing their powerful cuvette and spectrophotometer calibration ... path that FireflySci is going on as they add yet another mark on the ...
(Date:2/24/2017)... 2017  OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a ... Key Opinion Leader event to highlight new clinical data ... presentation at the upcoming 2017 ASCO-SITC Immuno-Oncology Symposium and ... be held in-person and via live webcast on Tuesday, ... PST at the Lotte New York Palace Hotel in ...
(Date:2/23/2017)... ... February 23, 2017 , ... BellBrook Labs is formalizing ... an array of biochemical analyses critical for Lead Discovery. The company’s Lead ... SAR programs, including inhibitor potency and selectivity, mechanism of action, and inhibitor residence ...
Breaking Biology Technology:
(Date:2/10/2017)... 10, 2017 Research and Markets ... "Personalized Medicine - Scientific and Commercial Aspects" to their ... ... is integrated with therapy for selection of treatment as well ... and prevention of disease in modern medicine. Biochip/microarray technologies and ...
(Date:2/8/2017)... 2017 The biometrics market has reached ... of organizations, desires to better authenticate or identify ... and challenge questions), biometrics is quickly working its ... market is driven by use cases, though there ... enterprise uses cases, with consumer-facing use cases encompassing ...
(Date:2/6/2017)... -- According to Acuity Market Intelligence, ongoing concerns ... continue to embrace biometric and digital identification based ... Control (ABC) eGates and 1436 Automated Passport Control ... ports of entry across the globe. Deployments increased ... CAGR of 37%. APC Kiosks reached 75% growth ...
Breaking Biology News(10 mins):