ProImmune Ltd., a leader in services for understanding immune responses,
announced today 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."
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