|By PR Newswire||
|January 7, 2014 02:01 AM EST||
LONDON, January 7, 2014 /PRNewswire/ --
~ ST10 strongly demonstrates potential to be (1) the only effective oral treatment for ferrous intolerant IDA patients and (2) an effective alternative to intravenous iron treatment ~
Shield Therapeutics (Shield), an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces strongly positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD).
ST10, a novel orally-dosed form of ferric iron, delivered a mean improvement in haemoglobin levels of 2.3g/dL (p <0.0001), clearly meeting the primary endpoint of haemoglobin change after 12 weeks' treatment compared to placebo. More than 65% of treated subjects experienced normalised haemoglobin levels by week 12 and ST10 also rapidly delivered significant improvements in haemoglobin at 4 weeks (1.1g/dL, p <0.0001) and 8 weeks (1.8g/dL, p <0.0001) of therapy. From a safety perspective, ST10 did not adversely affect IBD symptoms in treated subjects and was well tolerated for the duration of exposure.
The two AEGIS protocols recruited 128 patients with anaemia secondary to either Crohn's disease or ulcerative colitis who had previously failed therapy with oral ferrous products due to intolerance and/or inadequate therapeutic benefit. Patients were recruited from expert centres in Austria, Germany, Hungary and the UK and were randomised (1:1) to receive ST10 or a matched placebo capsule. Other iron therapies were not permitted during the study. Adverse events recorded during the study were mainly gastrointestinal in nature and occurred in the ST10-treated arm with placebo-like frequency (38% of ST10-treated subjects and 40% of placebo-treated subjects). Withdrawal from the study before 12 weeks (due to adverse events or subject decision) occurred in seven ST10-treated and nine placebo-treated subjects. Patients who completed the 12-week double-blind phase of the study continued treatment in a 12-month open-label extension phase and results of this will be available later this year.
These results provide confirmatory pivotal clinical data which will form the basis of a Marketing Authorisation Application submission to the European regulatory authorities during 2014. In conjunction with data that will be generated from the study of ST10 in the treatment of IDA in pre-dialysis chronic kidney disease patients that is currently progressing, these results will also form part of a subsequent New Drug Application submission to the FDA in the USA.
Full findings from the AEGIS studies will be presented at scientific congresses in due course.
Commenting on the results, Professor Christoph Gasche, Professor of Medicine, Medical University of Vienna, Austria, said:
"I have studied the problem of anaemia in inflammatory bowel disease (IBD) patients for many years, and the data from the AEGIS studies are very encouraging. Until now there has been no acceptable oral iron treatment available for the majority of my IBD patients with iron deficiency anaemia. These results are statistically very convincing and the 2.3 g/dL rise in haemoglobin at 12 weeks together with the more than 1.1g/dL rise in haemoglobin at 4 weeks compared to placebo are clinically meaningful for anaemic patients. The safety results from this study also show that ST10 is well tolerated with just a very small number of subjects withdrawing because of adverse effects and the frequency of GI side effects was similar in the placebo and ST10 groups. My personal experience of the patients that I treated in this study fits with these results."
Also commenting on the results, Dr Tariq Ahmad, Consultant Gastroenterologist at the Royal Devon and Exeter Foundation Trust, Exeter, UK, said:
"Iron deficiency anaemia is a real problem for many of my patients. Unfortunately patients often struggle with GI side effects caused by conventional ferrous iron salts. Currently we offer such patients intravenous iron in hospital. This is costly to administer, inconvenient for patients and associated with a small but significant risk of anaphylaxis. The exciting AEGIS Phase 3 data suggests that ST10 will provide an effective, safe and more convenient alternative to intravenous iron for this group of patients as demonstrated by ST10 keeping our patients out of the infusion room by correcting and maintaining their haemoglobin in the normal range."
Shield's Founder and Chief Executive Officer, Carl Sterritt, commented:
"Delivering such resoundingly positive findings from these pivotal trials of ST10 in IBD is a tremendous achievement for Shield; and the whole team is indebted to the patients and investigators who participated in the protocols. Our next aim is to make this therapy available as quickly as possible on a commercial basis to as wide an audience of prescribers and patients as we can, so we will be working diligently with regulatory authorities to achieve this goal.
"The results reflect an important milestone in the development of ST10 as the only effective, low-dose oral iron-replacement therapy without the significant GI side-effects of ferrous iron or the high risks associated with intravenous administration of iron. ST10 presents a significant opportunity for Shield to develop a paradigm changing treatment that will address a broad range of indications with a strong commercial potential and we look forward to rapidly advancing the programme."
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 has successfully completed a pivotal Phase 3 programme 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:
Carl Sterritt, Chief Executive Officer
Consilium Strategic Communications
Mary-Jane Elliott / Emma Thompson / Lindsey Neville
Early adopters of IoT viewed it mainly as a different term for machine-to-machine connectivity or M2M. This is understandable since a prerequisite for any IoT solution is the ability to collect and aggregate device data, which is most often presented in a dashboard. The problem is that viewing data in a dashboard requires a human to interpret the results and take manual action, which doesn’t scale to the needs of IoT.
Jul. 23, 2016 11:00 AM EDT Reads: 1,796
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Jul. 23, 2016 11:00 AM EDT Reads: 431
Cloud analytics is dramatically altering business intelligence. Some businesses will capitalize on these promising new technologies and gain key insights that’ll help them gain competitive advantage. And others won’t. Whether you’re a business leader, an IT manager, or an analyst, we want to help you and the people you need to influence with a free copy of “Cloud Analytics for Dummies,” the essential guide to this explosive new space for business intelligence.
Jul. 23, 2016 11:00 AM EDT Reads: 435
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, provided tips on how to be successful in large scale machine learning...
Jul. 23, 2016 11:00 AM EDT Reads: 1,116
What does it look like when you have access to cloud infrastructure and platform under the same roof? Let’s talk about the different layers of Technology as a Service: who cares, what runs where, and how does it all fit together. In his session at 18th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, an IBM company, spoke about the picture being painted by IBM Cloud and how the tools being crafted can help fill the gaps in your IT infrastructure.
Jul. 23, 2016 10:45 AM EDT Reads: 1,948
"C2M is our digital transformation and IoT platform. We've had C2M on the market for almost three years now and it has a comprehensive set of functionalities that it brings to the market," explained Mahesh Ramu, Vice President, IoT Strategy and Operations at Plasma, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 10:00 AM EDT Reads: 1,026
"delaPlex is a software development company. We do team-based outsourcing development," explained Mark Rivers, COO and Co-founder of delaPlex Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 10:00 AM EDT Reads: 1,885
Traditional IT, great for stable systems of record, is struggling to cope with newer, agile systems of engagement requirements coming straight from the business. In his session at 18th Cloud Expo, William Morrish, General Manager of Product Sales at Interoute, outlined ways of exploiting new architectures to enable both systems and building them to support your existing platforms, with an eye for the future. Technologies such as Docker and the hyper-convergence of computing, networking and sto...
Jul. 23, 2016 09:45 AM EDT Reads: 948
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Jul. 23, 2016 09:45 AM EDT Reads: 1,719
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Jul. 23, 2016 09:15 AM EDT Reads: 1,000
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jul. 23, 2016 09:00 AM EDT Reads: 1,912
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Jul. 23, 2016 09:00 AM EDT Reads: 809
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Jul. 23, 2016 08:30 AM EDT Reads: 649
It’s 2016: buildings are smart, connected and the IoT is fundamentally altering how control and operating systems work and speak to each other. Platforms across the enterprise are networked via inexpensive sensors to collect massive amounts of data for analytics, information management, and insights that can be used to continuously improve operations. In his session at @ThingsExpo, Brian Chemel, Co-Founder and CTO of Digital Lumens, will explore: The benefits sensor-networked systems bring to ...
Jul. 23, 2016 08:15 AM EDT Reads: 1,432
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
Jul. 23, 2016 08:00 AM EDT Reads: 1,234