PRA to conduct Ph Ib/II clinical trial of PLK1 inhibitor
Trovagene, Inc. has contracted PRA Health Sciences to conduct its Phase Ib/II clinical trial of PCM-075 in patients with acute myeloid leukemia (AML).
According to the company, PRA will support clinical site recruitment, clinical operations and regulatory proceedings for the development of PCM-075, a polo-like kinase 1 (PLK1) inhibitor.
The Raleigh, NC-based contract research organization (CRO) will assess safety, tolerability, dose and scheduling, and preliminary efficacy of PCM-075 in the Phase Ib/II clinical trial.
Trovagene has filed an Investigational New Drug (IND) application and protocol for PCM-075 to the US Food and Drug Administration (FDA).
The drug previously demonstrated an acceptable safety profile in a Phase I study in patients with advanced metastatic solid tumor cancers.
