Nonclinical Testicular

FEASIBILITY1 SCOPING2 RESEARCH3 SUBMITTED4 QUALIFIED5

blue U.S. Food & Drug Administration (FDA)

green European Medicines Agency (EMA)

Overview

Currently, there are no predictive biomarkers that indicate seminiferous epithelial damage.  A reliable, translatable biomarker of early damage to the seminiferous epithelium would allow clinical testing of therapeutically useful compounds while monitoring testicular safety.  The PSTC Testicular Toxicity Working Group (TWG) is currently evaluating the potential of miRNAs to fill this gap in drug development safety.  miRNAs are secreted in to the blood stream, and are unique to each cell type.  Thus, it is possible that miRNA which are secreted might be able to be used to detect damage to seminiferous epithelium.  A translational biomarker of seminiferous tubule damage could be used in nonclinical animal studies to define in vivo safety margins, and further applied in clinical trials for monitoring testicular safety.  Furthermore, for the first time this approach could enable direct assessment of risk of human testis injury posed by candidate drugs which exhibit testis damage in preclinical studies.