SK&F107647: A Synthetic Hematoregulatory Peptide in Patients With Solid Tumor Malignancies: A Phase I Trial

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Abstract

SK&F107647 is a synthetic hematoregulatory peptide (HP) increases both the number and function of progenitor cells, enabling improved survival after lethal myelosuppression, lethal fungal infection, and lethal herpes simplex virus infection in murine models. This Phase I single-blind placebo-controlled dose-rising crossover trial examined the efficacy of SK&F107647 in patients who had incurable solid tumor malignancies.

Sixteen patients were treated. Six adverse events in 3 patients were considered to be possibly related to SK&F107647; all were mild to moderate in nature (mild nervousness and agitation at 0.01 ng/kg, moderate fever and mild nausea at 0.1 ng/kg, elevated hepatic enzymes at 0.1 ng/kg, and mild vomiting at 1.0 ng/kg). Plasma half-life was 2.44 hours (±1.07 standard deviation). The observed area volume of distribution was 16.7 L (±7.7 standard deviation) and clearance was 5.04 L/hour (±1.83 standard deviation).

When administered as a single 2-hour intravenous infusion at doses ranging from 0.01 to 100 ng/kg, SK&F107647 is safe and well tolerated.

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