Risks analysis. As NI-0501 is a monoclonal antibody and is characterized by a long half-life, the Investigator should be aware of the risks reported below.
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Risks analysis. Risks related to NI-0501 NI-0501 is a monoclonal antibody of IgG1. Upon the administration of mAbs, which are proteins, acute infusion reactions can occur. These may happen during the infusion or in the subsequent hours (usually within the first 24 hours)29. These reactions are either IgE-mediated type I hypersensitivity reactions (anaphylactic reactions), or anaphylactoid reactions not mediated by IgE. True anaphylactic reactions usually do not occur upon initial infusion and require a certain sensitization. In contrast, the pathophysiology of anaphylactoid reactions appears to be secondary to the release of cytokines consequent to a mAb binding to circulating antigen-expressing cells. However, the clinical manifestations of anaphylactic and anaphylactoid reactions overlap, and both may lead to life-threatening conditions, involving cardiovascular, respiratory, central nervous, gastro-intestinal, and cutaneous systems. The management of anaphylactic and anaphylactoid reactions involves immediate administration of oxygen, epinephrine, vasopressors, bronchodilators, corticosteroids, and/or antihistamines. After 14 single infusions to HVs up to and including the dose of 3 mg/kg and more than 380 infusions administered to HLH patients (either in the context of the NI-0501-04 and NI-0501-05 studies or in patients who received NI-0501 in compassionate use) up to and including the dose of 10 mg/kg, no significant infusion related reaction has been observed. Only transient erythematous rashes localized to the extremities (feet and/or hands) resolving spontaneously have been observed in a few patients during the first infusions of NI-0501 in the NI-0501 study. On a few occasions, administration of NI-0501 has been performed through a peripheral venous access and all infusions were uneventful. • When administered to humans, most mAb therapeutics elicit some level of antibody response (anti-drug antibodies or ADAs) against the therapeutic product, as early as after the first exposure. No sign of immunogenicity has been reported in the NI-0501 study in healthy volunteers. The presence of ADAs will be measured throughout this study as per regulatory recommendations. The full analysis is planned to be performed at the end of the NI-0501-04 study. Data accumulated so far (in particular PK profiles and a negative ADA search performed in the only patient who developed hemolytic anemia during conditioning) have not led to suspect the presence of XXX. Risks related to the t...
