ProImmune Ltd. has 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 I 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.
Dr. Nikolai Schwabe, CEO of ProImmune, said “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. By offering ProStorm™, we at ProImmune are extending the range of services we offer to help our clients bring safe and effective therapeutics to market.”