Ongoing studies
CBC supports a wide range of research related to plasma gelsolin (pGSN). Currently, the company supports biochemical research projects including pGSN ligand binding and the development pGSN assay methods. The company supports preclinical research correlating changes in pGSN levels with the evolution of acute, subacute and chronic diseases in humans and into the effects of pGSN replacement therapy using recombinant human plasma gelsolin (rhu-pGSN, Solinex™) in animal models of acute, subacute and chronic disease.
The company has begun a pharmacokinetic study of intravenous infusion of Solinex™ in critically ill patients without evidence of organ system failure who have documented pGSN depletion. This double-blind, placebo-controlled trial will sequentially evaluate 3 different doses of rhu-pGSN. The first of these cohorts (3 mg/kg of rhu-pGSN given as a one hour infusion) has been completed and analyzed. The drug appears to be well tolerated with a 13 hour half life in these critically pGSN depleted patients. In the majority of patients, a 3 mg/kg dose of drug raised the circulating pGSN levels to a level above the empirically determine critical threshold of 3,000 mU/ml for 24 hours. This is the level of pGSN that is believed to be needed in such patients to prevent systemic mediator release from local tissue injury that would otherwise initiate an overwhelming pathological systemic inflammatory response resulting in sepsis syndrome and death. Although the small sample (10 treated patients and 3 placebo patients) precludes any statistically significant results, the proinflammatory cytokines IL-1β, TNFα and VEGF all rise over the first 24 hours in placebo patients while falling in the treated group providing directional support for the inflammatory suppressive action of the drug.
CBC is committed to supporting research into all aspects of pGSN. As such, for well designed studies, it provides ELISA kits for epidemiological studies and rhu-pGSN for animal and biochemical experimentation. If you have any ideas or questions regarding a research project, please contact us.
