US-based biotechnology company Trovagene has chosen global contract research organisation (CRO) PRA Health Sciences to carry out its Phase lb/ll clinical trial of PCM-075, a polo-like kinase 1 (PLK1) inhibitor, to treat patients with acute myeloid leukaemia (AML).
As part of the latest arrangement, PRA will help Trovagene in clinical site recruitment, clinical operations and regulatory proceedings for the development of PCM-075 in AML.
Trovagene has already filed an investigational new drug (IND) application and protocol for PCM-075 to the Food and Drug Administration (FDA).
Once approved, the company is planning to commence the Phase lb/ll study that will assess the safety, tolerability, dosage and scheduling, as well as preliminary efficacy of PCM-075 in patients with AML.
Trovagene CEO Bill Welch said: “We look forward to generating clinical data that we believe will assess the safety, tolerability, and anti-leukaemic activity of PCM-075 in a haematological malignancy.”
The company’s PCM-075 is an adenosine triphosphate (ATP) competitive inhibitor of the serine / threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in several different hematologic malignancies, as well as solid tumours such as breast, prostate, ovarian, lung, gastric and colon cancers.
The PLK1is orally bioavailable and has already been explored in an initial, open-label, dose-escalation safety Phase l study in patients with advanced metastatic solid tumour cancers.
PCM-075 demonstrated an acceptable safety profile, as well as anti-tumour activity in the study.
Last month, Trovagene signed a supplier agreement with Italy’s Nerviano Medical Sciences subsidiary NerPharMato manufacture drug product for PCM-075.