QSV Biologics, Ltd. and Critical Biologics Corp. Sign 2nd Contract for cGMP Manufacture of Plasma Gelsolin
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QSV Biologics, Ltd (QSV) and Critical Biologics Corp. (CBC) announced the signing of a second, repeat business, contract for the cGMP manufacturing of recombinant human plasma gelsolin (Solinex(TM)) being targeted for various critical care applications and end-stage renal disease patients on dialysis. QSV will be responsible for process development and cGMP manufacture of phase I/II clinical trial material in its commercially licensed cGMP manufacturing facility.
Plasma gelsolin (pGSN) is a naturally occurring, and highly evolutionary conserved, circulating plasma protein involved in the regulation and localization of inflammation. Severe depletion of plasma gelsolin has been found to correlate strongly with increased morbidity and mortality in a number of acute and chronic diseases. Experiments in animal models have shown that disease progression and adverse outcomes can be averted by a timely replenishment of plasma gelsolin using Solinex(TM). CBC is currently completing a Phase 2a placebo controlled safety and pharmacokinetic trial of Solinex(TM) in critical care patients identified as being at high-risk of developing sepsis using CBC's proprietary pGSN diagnostic assay, SolinDx(TM).
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