Ergomed is providing clinical research services
for the study and has been integrally involved in the design and implementation
of the study from a clinical and operational perspective.
Miroslav Reljanović, Executive Chairman of Ergomed, said:“COVID-19
represents an unprecedented global healthcare challenge and the rapid
evaluation of therapies which could alter the course of the infection and
improve outcomes for patients is vital. Ergomed is proud to be making a
contribution to this effort by bringing our proven capabilities and expertise
to bear on this important study.”
The full text of the announcement issued
by Papa Giovanni XXIII Hospital and EUSA on 18 March is as follows:
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
Hempstead, ENGLAND and Bergamo, ITALY– 18th March 2020 –
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 SeriousCOVID-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.
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
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.”
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
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
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.
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