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
Brenus Pharma Presented New Preclinical and Early Clinical Data in Colorectal Cancer During AACR Immuno-Oncology Conference 202619.2.2026 08:50:00 CET | Press release
Brenus Pharma, a clinical-stage biotechnology company pioneering in vivo “off-the-shelf” immunotherapies, announced the selection of an abstract for a poster presentation at the American Association for Cancer Research Immuno-Oncology (AACRIO) annual conference (February 18-21, 2026), in Los Angeles. The poster showcases new preclinical data and early clinical insights from the company's lead candidate, STC-1010, supporting it as a promising therapeutic option for MSS, immune-cold colorectal cancer (CRC)—a major unmet clinical need. In a syngeneic CT26 model, murine STC-1010 significantly inhibits tumor growth and extends survival by 40%. New mechanistic datas reveal expansion of CD4⁺ and CD8⁺ T cells in draining lymph nodes alongside a significant humoral response compared to control, demonstrating coordinated cellular and humoral immune activation in vivo. Other findings show that dendritic cells efficiently capture STC-1010, leading to their activation as demonstrated by transcripto
ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer19.2.2026 08:30:00 CET | Press release
Based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1 If approved, Daiichi Sankyo and AstraZeneca’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committ
NHOA Energy Advances Delivery of the 51 MWh Broni Battery for Neoen in Italy19.2.2026 08:00:00 CET | Press release
The project confirms NHOA Energy’s long-term commitment to the Italian market NHOA Energy, global provider of utility-scale energy storage systems, is advancing the construction of the Broni Battery, a 10 MW/51 MWh project located in Broni (Pavia), Italy, executed for Neoen, one of the world’s leading independent producers of renewable energy. Civil works at the site are currently underway and advancing on schedule, with commissioning activities planned to start in late spring 2026. Once operational, the Broni Battery will provide essential flexibility services to the Italian electricity system, supporting grid stability and reliability as renewable energy penetration continues to increase. The project represents Neoen’s first battery storage asset in Italy and marks a strategic step in the company’s expansion, as it continues to grow its battery storage portfolio in key markets worldwide to support power system flexibility. The Broni Battery further strengthens NHOA Energy’s long-term
Compass Pathways Announces Pricing of $150 Million Public Offering19.2.2026 02:18:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the pricing of its public offering of 17,500,000 American Depositary Shares (“ADSs”) at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per pre-funded warrant. In addition, Compass Pathways has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 ADSs at the public offering price, less the underwriting discounts and commissions. All of the securities are to be sold by Compass Pathways. The offering is expected to close on or about February 20, 2026, subject to the satisfaction of customary closing conditions. The gross proceeds to Compass Pathways from the offering, before deducting underwriting discounts and commissions and other est
Andersen Consulting udvider sine kompetencer inden for ledelsesrekruttering med Lansdowne Executive Search18.2.2026 17:08:00 CET | Pressemeddelelse
Andersen Consulting styrker sin humancapital-praksis gennem en samarbejdsaftale med Lansdowne Executive Search, der er en Dublin-baseret virksomhed med speciale i lederrekruttering, midlertidige ledelser og bestyrelsesudnævnelser. Lansdowne Executive Search er en irisk-ejet virksomhed, der blev grundlagt i 2015, og som tilbyder C-level-ledelsesekruttering, deltidsledere og bestyrelsesplaceringer. Som en partnerdrevet boutique-virksomhed er Lansdowne kendt for, at seniorledelsen er tæt involveret i alle kundeprojekter. Virksomheden hjælper kunder med at navigere i komplekse ledelsesovergange og vækststrategier på tværs af en bred vifte af sektorer, herunder finans, byggeindustrien, nonprofit, landbrug, videregående uddannelse, den offentlige sektor samt teknologi, medier og telekommunikation. "God ledelse er afhænger af situationen, og det kræver forståelse af langt mere end blot et CV," sagde Tom Keane, der er partner hos Lansdowne Executive Search. "Samarbejdet med Andersen Consulting
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