Navigation Links
Shield Therapeutics Completes Recruitment to Pivotal Phase 3 Programme for Treatment of Iron Deficiency
Date:6/23/2013

LONDON, June 24, 2013 /PRNewswire/ --

Shield Therapeutics, the independent specialty mineral medicines pharmaceutical company, today announces that it has completed recruitment of patients into its pivotal Phase 3 programme of ST10 for the treatment of iron-deficient anaemia.  ST10 is a novel form of ferric iron taken orally.

Patients with inflammatory bowel disease and anaemia have been recruited and randomised when oral ferrous products have been ineffective due to intolerance and/or inadequate therapeutic benefit.  The primary endpoint of this pivotal international, multi-centre programme is haemoglobin change after 12 weeks' treatment with ST10 compared to placebo.  Subjects have been included from expert centres in Austria, Germany, Hungary and the UK and either randomised to receive 30mg of ST10 twice a day, or a matched placebo capsule.  Following the randomised treatment period there is an open-label phase that allows all patients to be treated with ST10 for an additional year.  Other iron therapies have not been permitted during the study.  

Shield Therapeutics expects to report top-line results from the study at the end of Q4 2013 and anticipates these results will provide confirmatory pivotal clinical data that may form the basis of an MAA submission to the European regulatory authorities in 2014.  The data is also expected to form part of a subsequent NDA submission in the USA.

Commenting on the study, Professor Gasche, Professor of Medicine, Medical University of Vienna, Austria said:

"Inflammatory bowel disease is one of the most prevalent diseases managed by gastroenterologists.  Approximately half of all IBD patients develop iron deficiency and that can readily progress to more severe anaemia, which is the leading cause of fatigue that debilitates day-to-day quality of life.  The oral ferrous iron preparations are often poorly tolerated, leaving intravenous iron infusions as the preferred option.  However these require significant additional patient time and healthcare resources, hence there is an urgent need for a more convenient solution which we anticipate ST10 may deliver."

Shield Founder and Chief Executive Officer, Carl Sterritt, added:

"We are very grateful to the patients for their commitment, as well as the investigators and their research staff for their hard work and considerable skill that has made this study possible.  The completion of recruitment into this pivotal trial is an important step in bringing orally dosed ST10 to market as an effective way of correcting anaemia in patients who cannot tolerate oral ferrous iron therapy and so have to rely on the higher risk option of invasive and resource-consuming intravenous administration of iron."

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 pivotal Phase 3 studies of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with inflammatory bowel disease and is soon to commence a Phase 3 study of ST10 for the treatment of iron deficiency anaemia in patients with chronic kidney disease.

For more information about Shield Therapeutics, please contact:
M:Communications
Mary-Jane Elliott / Sarah Macleod/ Hollie Vile
Tel +44(0)20-7920-2330
Email: shieldtherapeutics@mcomgroup.com



'/>"/>
SOURCE Shield Therapeutics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. ASSA ABLOY Door Group Announces RF Shielding Openings
2. Blue Cross Blue Shield Texas Launches "Be Covered Texas" Campaign to Raise Awareness of Individual Health Insurance Enrollment Options
3. Radiation Detection, Monitoring & Safety Market (Geiger Counter, Ionization Chamber, Scintillator, Terahertz detector, Dosimeter, Environment Monitor, Shield, Lead Apron, Eyewear & Glove) - Competitive Analysis & Global Forecasts to 2017
4. Healthcare Fraud Shield Now Offers SIU Services
5. FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)
6. BI-LO Offers Health Giveaways With Flu Vaccinations, Encourages Community To Shield Their Health This Flu Season
7. Shield HealthCare Announces 12th Annual Caregiver Story Contest
8. Wellness Center USA, Inc. Completes Psoria-Shield Inc. Acquisition
9. Healthcare Expense Management Leader Patientco Receives $3.75M in funding led by BlueCross BlueShield Venture Partners and Sandbox Industries
10. Wellness Center USA Inc. Signs Agreement to Acquire Psoria-Shield Inc.
11. Blue Cross Blue Shield of Michigan and Blue Care Network support the Drug Enforcement Administrations Nationwide Prescription "Drug Take-Back Day"
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ANDOVER, Mass. and SAN CLEMENTE, Calif. ... California -based mobile pulmonary function testing company, is now ... portable PFT devices developed by ndd Medical Technologies , Inc. ... PFT testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ... CA , can get any needed testing done in the ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... Ill. , June 23, 2016  In a startling report ... are failing their residents by lacking a comprehensive, proven plan to ... a definitive ranking of how states are tackling the worst ... to only four states – Kentucky , ... Vermont . Of the 28 failing states, three ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... ... Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The ... published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , ...
(Date:6/24/2016)... ... ... National recruitment firm Slone Partners is pleased to announce the placement ... Vice President of North American Capital Sales at HTG Molecular . ... in the commercialization of the HTG EdgeSeq system and associated reagents in North America. ...
(Date:6/24/2016)... ... 2016 , ... Finally, a bruise cream that really works. Originally designed ... into the post-surgical treatment plans of a variety of other procedures including, but not ... effective for bruising and causes a rapid resolution of bruising and inflammatory changes compared ...
(Date:6/24/2016)... ... June 24, 2016 , ... SpiritQuest Sedona Retreats, located in Arizona ... surrounded by famous vortex sites: Cathedral Rock, Airport Mesa, and Boynton Canyon. The new ... Lodge at Sedona as well as the Sedona Rouge, both popular accommodations for SpiritQuest ...
(Date:6/23/2016)... ... 2016 , ... vcfo, a consulting firm that provides access ... the promotion of Mike Mackey to Regional Vice President of Southeast Texas. , ... for managing client projects and overseeing vcfo financial consultants in the Houston area. ...
Breaking Medicine News(10 mins):