Abstract
Oxygen therapeutics is anticipated to play an important role in easing the increasingly frequent shortages of donor blood. These agents would also avoid several transfusion-related safety issues, and could thereby profoundly change the practice of transfusion medicine in the future. Significant clinical development challenges remain, however, since regulatory approval of these products for a transfusion avoidance indication may require that they be proven to be as safe as allogeneic blood. Oxygent, like Oxyfluor, is a “second-generation” perfluorocarbon-based emulsion. Oxygent contains 60 g of the perfluorochemical perflubron per 100 ml of emulsion, and also contains a small quantity of perflubrodec, added as a stabilizer. The concentration and oxygen capacity of Oxygent is approximately three times that of Fluosol and Perftoran. The formulation and manufacturing of Oxygent is optimized, and the stability of the emulsion enables it to be stored for long periods of time. Early formulations of Oxygent induced transient inflammatory responses in animals and humans. Subsequent formulations overcame these side effects. Oxygent experience strokes significantly more frequently than control patients. These results are attributed to defects in design of the clinical trials and procedures for the use of Oxygent, rather than to inherent properties of the emulsion. Nevertheless, economic pressures forced cessation of clinical development.
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