First patient treated with IdeS in Phase II study in

New Post Public Reply Private Reply Replies (0) Message Board

News Desk 2018

Oct 11, 2016 at 2:45 AM

First patient treated with IdeS in Phase II study in acquired Thrombotic Thrombocytopenic Purpura (TTP)

Hansa Medical AB (publ) today announced that the first patient has been recruited and treated in a Phase II clinical study with IdeS in the acute autoimmune disease acquired Thrombotic Thrombocytopenic Purpura (TTP) at University College Hospital in London. Acquired TTP is a severe and acute autoimmune blood disorder in which the presence of autoantibodies can result in systemic life threatening micro -clotting in vital organs. The Hansa Medical-sponsored study with IdeS in TTP is an open-label study to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of IdeS in asymptomatic patients with acquired TTP. The patients in the study will have low ADAMTS13 activity. ADAMTS13 is a significant component in the coagulation system. An important goal of the study is to investigate if one dose of IdeS results in increased ADAMTS13 activity by cleaving ADAMTS13 autoantibodies. The Clinical Investigator, Dr. Marie Scully, consultant haematologist at UCLH, is a leading expert in patient care and clinical research in TTP. The study will include up to six patients with acquired TTP and low ADAMTS13 activity who are asymptomatic at the time of enrolment into this study. The study is expected to be completed during 2017. “This novel therapy, initially investigated to determine safety and efficacy, could provide an innovative treatment for acute TTP, clearing the antibodies against ADAMTS 13, aiding response to remission and reducing morbidity and mortality”, says Dr. Scully, who is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. “We are happy to now announce our progress into the autoimmune space through the initiation of this explorative Phase II trial with IdeS in acquired TTP. The effective and fast IgG-cleaving mode-of-action of IdeS makes it highly relevant to evaluate the efficacy and safety of IdeS in this potentially devastating acute condition“, says Göran Arvidson, CEO of Hansa Medical AB. The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of Göran Arvidson stated below on October 11, 2016 at 08.30 CET. For further information, please contact: Emanuel Björne, Vice President Business Development and Investor Relations, Hansa Medical AB (publ) Mobile: +46707175477 E-mail: emanuel.bjorne@hansamedical.com Göran Arvidson, CEO , Hansa Medical AB (publ) Mobile: +4670633 3042 E-mail: goran.arvidson@hansamedical.com About acquired TTP Acquired TTP is an ultra-rare, acute, auto-immune blood clotting disorder, affecting 1/100,000 inhabitants. It has a sudden onset caused by impaired activity of the ADAMTS13 enzyme (typically <10% of that in plasma of healthy individuals), leaving ultra-large Von Willebrand Factor (vWF) molecules un -cleaved (vWF is an essential protein involved in the blood clotting process). These ultra-large vWF molecules bind to blood platelets, resulting in severe thrombocytopenia (very low platelet counts) and formation of micro-clots in small blood vessels throughout the body. Acquired TTP is associated with severe morbidities of the brain, heart and kidney and affects life expectancy and quality of life. Mortality is high at 10-15% within 2 weeks after initial diagnosis. Moreover, the risk of recurrences is high in patients with persistently low levels of ADAMTS13 after treatment with the current standard of care, which consists of daily plasma exchange and immune-suppressants. About IdeS IdeS, a unique molecule with a novel mechanism, is an enzyme that specifically cleaves human IgG antibodies. IdeS has been evaluated in a Phase I study in healthy subjects and in a Phase II study in sensitized patients awaiting kidney transplantation demonstrating that IdeS is highly effective in reducing anti-HLA antibodies to levels acceptable for transplantation with a favorable safety profile. The efficacy and safety of IdeS in transplantation are currently investigated in three on-going Phase II studies in sensitized kidney patients in Sweden and the US. In addition to transplantation, IdeS has potential applications in a variety of rare autoimmune diseases and currently, the efficacy and safety of IdeS are investigated in a Phase II study in acquired Thrombotic Thrombocytopenic Purpura. About Hansa Medical AB (publ) Hansa Medical is a biopharmaceutical company focusing on novel immunomodulatory enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical development, with potential use in transplantation, rare autoimmune diseases and oncology. Additional projects focus on development of new antibody modulating enzymes, as well as HBP, a diagnostic biomarker for prediction of severe sepsis at emergency departments that is already introduced on the market. The company is based in Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on Nasdaq Stockholm. About UCLH UCLH (University College London Hospitals NHS Foundation Trust), situated in the West End of London, is one of the largest NHS trusts in the United Kingdom and provides first-class acute and specialist services. The state-of-the-art University College Hospital which opened in 2005, is the focal point of UCLH alongside four cutting-edge specialist hospitals. UCLH is committed to research and development and forms part of UCL Partners which in March 2009 was officially designated as one of the UK's first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. For more information, visit: www.uclh.nhs.uk, Facebook (UCLHNHS), Twitter (@UCLH) or Youtube (UCLHvideo).

Newer

Older

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Amap, Sands China Unleash Tutu Robots for Resort Duty

Tutu Robots Usher in a New Technological Era for Sands China Alright, let's dive into some tech that feels out of a sci-fi movie and see what Sands China and Amap have cooked up as they introduce the Tutu robot dogs to Sands Resorts Macau. These aren't your run-of-the-mill gadgets—they're futuristic tour guides ready to rewire visitor experiences. The delivery ceremony...

Armor Health Strengthens Corrections Care with New Leader

Fresh Blood in Correctional Healthcare Talk about stepping up where it counts! Armor Health is shaking things up, bringing in Jill Bromley as their new Regional Behavioral Health Director. The name might not ring any bells for the average Joe, but in the world of correctional healthcare, it’s like they've just upgraded from a sedan to a sports car. Armor’s game here...

India's Women Apparel Market Grows Amid Innovation

India's Women Apparel Market on the Rise The winds of fashion change are sweeping through India, and the women's apparel market is at the heart of this sartorial hurricane. Set to explode from USD 28,786.82 million in 2024 to USD 45,491.96 million by 2032, this market is turning heads with a compound annual growth rate (CAGR) of 5.21%. What's stirring this pot, you ask?...

Zoomlion Boosts Mining Gear Amid Global Revenue Surge

An Ambitious Expansion Overhaul Alright, let's talk Zoomlion Heavy Industry Science & Technology Co., Ltd. They're not just making a splash; they're wading knee-deep into expanding their mining machinery operations and taking charge in international markets. You see, in the first half of 2026, this Chinese behemoth saw its mining machinery business skyrocket by over...

TKO's Bold $2B All-Cash Move for SVC's Hotels

TKO's Big, Bold Bid: What Does it Mean? In the crazy world of high-stakes hospitality investments, there are moments that turn heads. TKO's $2 billion all-cash offer to snag Service Properties Trust's prized hotel portfolio is exactly one of those shake-ups. Let's not sugarcoat it; this is a bold move to the big leagues, and it's not without its quirks. A Cash-Infused...

NOARK: Powering Data Centers with Global-Local Approach

The High-Stakes Race for Data Center Power These days, if you're not talking about data centers, you're probably a step behind the curve. AI's explosive growth is pushing data center developments across North America like never before. Larger campuses, hefty power densities—it's all happening at a pace that's got everyone scrambling. For folks like NOARK Electric, this...

Toyland 2026: Blain's 'Open The Magic' Event Marks 69 Years

There's something about nostalgia that hooks you right in the gut, like remembering those jittery walks through Blain's Farm & Fleet's Toyland aisles. If there's one thing these folks know, it's how to spark holiday cheer deep in the Midwest bones. Here we are, just before the dust settles on another year, and Blain's is rolling out its 69th Toyland party—a cherished...

RingConn Smart Ring Gains Key FDA 510(k) Clearance

FDA Clearance: A Major Step for RingConn In a space where every tiny gadget-maker is desperately clawing for a regulatory nod, RingConn—a venture born from Shenzhen Ninenovo Technology Limited—has snagged an FDA 510(k) clearance (Clearance No. K260490) for their wearable Smart Ring that measures blood oxygen levels non-invasively. October 10, 2026, marked the day when...

Navigating Career Growth Beyond Job Titles at Webinar

Hasn't it ever struck you that job titles often fence people in like some unwanted corral, keeping potential tightly leashed? Well, here's something that might shake up your thoughts a tad. University of Phoenix is teeing up a webinar titled "Beyond The Job Title: Finding Purpose and Recognizing the Value You Bring." Scheduled for October 15, 2026, this is all about...

Zenni and Chase Stokes Foster Student Wellbeing in NYC

Picture this: near 300 high schoolers milling around, glancing through shiny new glasses from the Zenni x Chase Stokes collection. In the heart of New York City, these kids are getting a double-dose of care that's all too rare—free vision screenings paired with mental health support. It's the kind of collaboration that shows you what's possible when a company, an actor,...