EUSA-PHARMA
18.3.2020 09:35:13 CET | Business Wire | Press release
EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease, today announced the initiation of the Papa Giovanni XXIII Hospital sponsored study of siltuximab, an interleukin (IL)-6 targeted monoclonal antibody, for the treatment of patients with COVID-19 who have developed serious respiratory complications (S iltuximab I n Serious CO VID-19; SISCO Study). Ergomed plc (LSE: ERGO), a company focused on providing specialized services to the pharmaceutical industry, is providing clinical research services for the study.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200318005218/en/
Professor Alessandro Rambaldi, MD, PhD, Papa Giovanni XXIII Hospital, Bergamo, Italy, Study Sponsor-Investigator and Director of the Hematology Unit and Department of Oncology and Hematology , said: “The team at Papa Giovanni XXIII Hospital are thankful to EUSA Pharma for the supply of siltuximab for compassionate use in patients with serious complications of COVID-19 and the opportunity to generate data to understand the potential for IL-6 blockade in these patients. The SISCO Study will allow us to generate credible data as evidence to guide future treatment and research decisions and we look forward to publication of these data as quickly as possible. The Hospital is in a very difficult emergency situation and rapid collection and analysis of data by way of a case-control study will provide much needed information to help address this critical situation and appropriately guide the use of medicines in an off-label situation.”
Lee Morley , Chief Executive Officer , EUSA Pharma , said: “We are delighted to support this study to investigate the potential for siltuximab to help patients severely ill as a result of COVID-19. Following the release of initial data from China suggesting a role of IL-6 in the development of Acute Respiratory Distress Syndrome as a result of COVID-19, EUSA Pharma was pleased to assist Papa Giovanni XXIII Hospital with the supply of siltuximab under compassionate use and to support the collection, analysis and publication of initial outcome data from this series of patients. We look forward to working further with the Hospital as well as Italian and Worldwide Regulatory Authorities, and other research bodies to fully understand the potential of siltuximab at this critical time in the global pandemic.”
About the SISCO Study
Sponsored by the Papa Giovanni XXIII Hospital, the SISCO Study is an observational case-control trial of siltuximab, a chimeric monoclonal antibody targeting human interleukin (IL)-6, for the treatment of patients infected with COVID-19 who develop serious respiratory complications.
The study represents the data collection and analysis of a series of patients treated under an ongoing emergency compassionate use protocol. The study will investigate two cohorts retrospectively, hospitalised patients prior to admission to an intensive care unit (ICU) or patients already requiring intensive care, and will compare to matched controls. Primary endpoints are reduction in the need of invasive ventilation, time spent in ICU or 30-day mortality.
Emerging evidence suggests that exacerbated production of the inflammatory cytokine IL-6 is associated with the severity of COVID-19 related pulmonary pathology associated with Acute Respiratory Distress Syndrome (ARDS). Therefore, direct targeting of this cytokine may improve clinical outcomes in these critically ill patients.
This study will provide important data to inform future clinical studies, discussions on which are ongoing, to further investigate the efficacy of siltuximab in patients with COVID-19 who develop serious respiratory complications. Initial data are expected in late March 2020.
#ENDS#
About siltuximab
Siltuximab is a monoclonal antibody that blocks the action of interleukin (IL)-6, a multifunctional cytokine detected at elevated levels in multiple inflammatory conditions.
It is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) under the brand name of SYLVANT® for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative (idiopathic MCD; iMCD). iMCD is a rare, life-threatening and debilitating lymphoproliferative disorder, which causes abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.
EUSA Pharma has exclusive rights to SYLVANT® globally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to SYLVANT® in Greater China.
Indications and Usage of SYLVANT® - See full Prescribing Information for additional information .
SYLVANT® (siltuximab) is indicated for the treatment of patients with multicentric Castleman disease (MCD) who are HIV negative and HHV-8 negative.
Limitations of Use: SYLVANT® was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT® did not bind to virally produced IL-6 in a nonclinical study.
Contraindications : Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT® .
Dosage and Administration
Administer SYLVANT® 11 mg/kg over 1 hour as an intravenous infusion every 3 weeks until failure.
Perform hematology laboratory tests prior to each dose of SYLVANT® therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT® . Do not reduce dose.
Do not administer SYLVANT® to patients with severe infections until the infection resolves.
Discontinue SYLVANT® in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit: www.eusapharma.com .
About Papa Giovanni XXIII Hospital
Papa Giovanni XXIII Hospital is one of the biggest hospitals in Lombardy, covering 320 thousand square meters in total and comprising more than 900 beds. Among the areas of excellence, an important role is covered by the Cancer Center that brings patients from the whole national territory and also from foreign countries. The Hospital is playing a leading role in the Italian response to the ongoing global COVID-19 pandemic.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200318005218/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 14:00:00 CEST | Press release
Non-arteritic anterior ischemic optic neuropathy (NAION) is a loss of blood flow to the optic nerve which causes spontaneous and rapid vision loss, for which there are currently no FDA-approved treatments. Given the substantial unmet need for effective treatments in NAION, in October 2025, Dompé was awarded a Commissioner’s National Priority Review Voucher (CNPV) by the US FDA to accelerate a potential Biologics License Application for intranasal nerve growth factor (NGF) in NAION. Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 202
CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 14:00:00 CEST | Press release
New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25%
Cover Genius Raises USD $100M Backed by Vista Credit Partners, Reaching USD $1.9 Billion Valuation as it Advances AI-First Platform and Global Expansion14.7.2026 14:00:00 CEST | Press release
Accelerating the AI roadmap and next era of embedded protection Cover Genius, the global infrastructure for embedded protection, today announced a USD $100M capital raise, backed by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on enterprise software. The raise values the business at USD $1.9 billion, advancing a new chapter for the company. Cover Genius operates a B2B2C embedded protection platform that connects 200+ partners with 50+ global insurance carriers to protect over 70 million end customers at the point of sale across travel, retail, ticketing and logistics. Unlike traditional insurers, Cover Genius dynamically adapts product design, pricing, and presentation in real time to match each merchant's unique customer journey and geography mix. “We’ve spent more than a decade building the trust layer the world’s largest digital companies rely on to protect their customers. Today’s raise is about broadening possibilities: movin
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 14:00:00 CEST | Press release
New Titles Expand on Landmark Work to Showcase How GIS Drives Better Decisions Across Water and Land Management Esri will debut the Power of Where Collection at the 2026 Esri User Conference. The collection builds on the 2024 book The Power of Where by Jack Dangermond, extending its ideas into real-world GIS applications. New titles in the collection highlight GIS uses in water forecasting, land records, infrastructure planning, and economic development. The series demonstrates how spatial analysis helps organizations address challenges including sustainability, climate resilience, and governance. Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world a
Esri Introduces ArcGIS for ServiceNow, Bringing Location Intelligence into Everyday Enterprise Workflows14.7.2026 14:00:00 CEST | Press release
New Integration Connects Platforms, Enabling Real-Time Mapping Directly Within Existing Systems Esri is launching ArcGIS for ServiceNow, an integration that connects ServiceNow, the AI control tower for business reinvention, with ArcGIS, bringing location intelligence into everyday enterprise workflows. The solution supports organizations across commercial, government, health care, utilities, energy, telecom, and other sectors. Users can visualize incidents, assets, work orders, facilities, and other business data on maps in real time within ServiceNow or ArcGIS, improving decision-making and operational efficiency. The integration eliminates data duplication by enabling seamless data sharing between systems, bridging business records with geographic context. ArcGIS for ServiceNow will debut in beta shortly after Esri User Conference. Esri, the global leader in geographic information system (GIS) technology, has announced ArcGIS for ServiceNow, connecting the two platforms for the firs
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom