Somatogen Inc. released further details on Monday from its Phase Isafety study of rHb1.1, a recombinant human hemoglobin, which wasfirst reported on last August.Four separate Phase I studies included 93 human subjects, 76 of whomwere infused with rHb1.1. There were no serious adverse events, theBoulder, Colo., company said, adding that there was no renalimpairment and mean values for hematologic measurements, hepaticenzyme functions and coagulation parameters were normal. Incidencesof transient fever seen at low doses early in the trial were lessened aftera manufacturing modification. Gastrointestinal symptoms were reducedby common pharmacological agents, and a transient blood pressureincrease, observed at higher doses, was not of clinical consequence, thecompany said.Clinical trials of rHb1.1 in anesthetized surgical patients began in thefall.The company hopes the product reduces or eliminates a surgicalpatient's exposure to donor blood by using recombinant humanhemoglobin as an alternative to transfusion.Jim Shrine
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