Business Wire

EUSA Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy Announce Initiation of an Observational Case-control Study of Siltuximab in Patients with COVID-19 who have Developed Serious Respiratory Complications

Share

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 (Siltuximab In Serious COVID-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.

Contact information

Lee Morley
Chief Executive
EUSA Pharma
Tel: +44 (0)330 5001140

Barney Mayles
Associate Director
OPEN Health
Mobile: +44 (0)7936 768568

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Piper Sandler Completes Acquisition of Preeminent Chemicals Investment Bank, The Valence Group4.4.2020 00:13:00 EESTPress release

Piper Sandler Companies (NYSE: PIPR), a leading investment bank and institutional securities firm, today announced it has completed its acquisition of The Valence Group, a premier international investment bank specializing in the chemicals, materials and related sectors. The Valence Group will operate as Piper Sandler’s new chemicals & materials group, adding yet another industry-leading advisory practice to the Piper Sandler platform. In addition, Peter Hall, one of the founders of The Valence Group, will now lead Piper Sandler’s expansion of investment banking in Europe. Piper Sandler was advised by its wholly owned subsidiary, Piper Sandler & Co., and was represented by Sullivan & Cromwell LLP. Houlihan Lokey served as financial advisor and Dentons as legal advisor to The Valence Group in connection with the transaction. About Piper Sandler Piper Sandler is a leading investment bank and institutional securities firm driven to help clients Realize the Power of Partnership®. Through a

BitHull Overtakes ASIC Market with New FPGA Miners3.4.2020 20:38:00 EESTPress release

BitHull S.A. ( www.BitHull.com ) is pleased to announce the launch of its two new crypto miners BH Miner and BH Miners Box. These miners have been built around Field Programmable Gate Array or FPGA mining technology, the latest breakthrough in crypto mining. FPGA mining makes use of the new generation of FPGA chips capable of delivering high hash rate power at low power consumption. Owing to its outstanding features, FPGA mining is expected to overtake ASIC mining very soon. BH Miner and BH Miners Box are multi-algorithm miners capable of mining bitcoin, litecoin, ethereum, and monero. BH Miners Box is a box combining 6 BH Miner units connected to each other. Mentioned below are the key features of the two miners. BH Miner Hash Rates: Bitcoin: 360 TH/s, Litecoin: 60 GH/s, Ethereum: 15 GH/s, and Monero: 3 MH/s BH Miners Box: Bitcoin: 2160 TH/s, Litecoin: 360 GH/s, Ethereum: 90 GH/s, and Monero: 18 MH/s Power consumption: 550W and 550W x6 for BH Miner and BH Miners Box respectively The o

Celltrion’s COVID-19 Antiviral Treatment Enters the Next Phase of Development3.4.2020 11:00:00 EESTPress release

Celltrion Group today announced its successful transition to the second phase of development for an antiviral treatment to fight the novel coronavirus (COVID-19) pandemic, following the completion of the first phase of securing 300 different types of antibodies that bind to the antigen last month. The library of antibodies was created using the blood of recovered patients in Korea. In cooperation with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion will be screening the antibodies to find the ones most effective in neutralising SARS-CoV-2, the virus responsible for COVID-19. Celltrion anticipates the candidate screening for the therapeutic monoclonal antibody (mAb) will be complete by mid-April, sooner than originally expected. Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “Once we have selected the one that most effectively neutralizes the COVID-19 virus among hundreds of the screened antibodies, we will roll out mass production of the therapeutic antibody t

Oracle Water System of MAK Leads Prevention of COVID-19 in Korea3.4.2020 08:18:00 EESTPress release

The ozone water produced by Oracle Water System was proved to be effective in preventing epidemics as it was used in Korea which is recognized as an exemplary country in addressing Coronavirus Disease-19 (COVID-19) drawing attention from the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200402005897/en/ The ozone water ‘Oracle Water’ produced by Oracle Water System was proved to be effective in preventing epidemics as it was used in Korea which is recognized as an exemplary country in addressing COVID-19 drawing attention from the world. ‘Oracle Water’ was begun to be used as sterilizing water in Daegu, Korea and demonstrated the remarkable effect of preventing COVID-19. The number of confirmed COVID-19 cases in the city decreased from 390 on March 7 when the sterilizing water was begun to be used to 297 cases on March 8, 190 cases on March 9 and to 32 cases on March 17, showing a reduction by 91.7%. Using plasma, Or

Strategic Investment of NXP in Kalray3.4.2020 00:52:00 EESTPress release

Kalray (Euronext Growth Paris : ALKAL – the “Company”), a pioneer in processors for new intelligent systems, today announces a strategic investment from NXP Semiconductors N.V. (NASDAQ: NXPI) for €8 million (approximately US$9 million), to enable the companies to develop together safe, reliable and scalable solutions for autonomous driving, combining NXP Automotive solutions and Kalray MPPA® (Massively Parallel Processor Array) Intelligent Processors. The investment will be carried out through the reserved issuance to NXP BV, a company of the NXP Group, of 503,461 ordinary shares without pre-emptive rights for the existing shareholders of the Company. Upon settlement-delivery of the new shares, the NXP Group will hold ca. 9.95% of Kalray’s share capital and voting rights. The settlement-delivery of the new shares is scheduled for April 7, 2020 and their admission to the Euronext Growth Paris multilateral trading system is scheduled for April 8, 2020. STRATEGIC NATURE OF THE TRANSACTION

Kalray: Information About Covid-193.4.2020 00:05:00 EESTPress release

Kalray (Paris:ALKAL) (Euronext Growth Paris : ALKAL), a pioneer in processors for new intelligent systems, is sharing the status on its activity and the continuation of its activity following the various health measures taken by the French government. The impact of Covid-19 epidemic on Kalray’s research and development activity, which is not too dependent on its suppliers, is expected to be limited and Kalray is hopeful it will be able to stick to its development roadmap. The development teams are fully operational thanks to telework, which was put in place as soon as the containment was announced in France on Monday March 16. The company does not use technical unemployment to date. However, the global health situation related to the Covid-19 epidemic and the containment measures implemented in many countries are likely to slow down business cycles, which could delay the deployment of some of company’s projects. At this stage, Kalray is currently assessing all the impacts of this crisi

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