Ergomed Announces Provision of Clinical Research Services for COVID-19 Clinical Study - Seite 3

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.