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ProImmune Ltd., a leader in services for understanding immune responses, announced the commercial launch of ProStorm, an in vitro cytokine release assay, which can help assess the likelihood of first infusion reactions to novel therapeutics. ProStorm offers drug developers an improved route to risk identification prior to initiating clinical trials in man.

Cytokine release syndrome (cytokine storm) is an acute immune reaction to first infusion of a drug, characterized by immediate release of proinflammatory cytokines. A lack of understanding of the risk of this reaction contributed to a near-fatal cytokine storm in participants in Phase 1 clinical trials of TGN1412. There is a clear need for preclinical assays such as ProStorm to assess the likelihood of this syndrome occurring. If a potential risk is indicated, lower doses of the therapeutic can be used alongside prophylactic antihistamines or steroids to mitigate that risk.

ProStorm is designed specifically to indicate when a cytokine storm first infusion reaction may be a risk for a drug. The ProStorm assay uses fresh undiluted whole blood from a large cohort of donors, to give a sensitive evaluation of cytokine responses to a therapeutic in one simple step.

First infusion cytokine storm reactions to new therapeutics can represent a substantial stumbling block to drug development. Now, using the ProStorm assay service, developers of biologics can gain valuable information to inform the design of their first-in-man trials.

ProImmune Ltd.

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