Biotechnology firm Trovagene has submitted a protocol to the US Food and Drug Administration (FDA) for a Phase II clinical trial of PCM-075 to treat metastatic castration-resistant prostate cancer (mCRPC).
PCM-075 is a selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme over-expressed in several hematologic cancers and solid tumours.
The multi-centre, open-label Phase II trial will be carried out in combination with standard dose of abiraterone acetate (Johnson & Johnson’s Zytiga) and prednisone.
Planned to assess the safety and efficacy of oral PCM-075, the trial will enrol around 25 subjects who display signs of early progressive disease while on androgen deprivation therapy (ADT) in conjunction with abiraterone and prednisone.
A follow-up will be carried out around every six weeks until disease progression in participants with stable disease or better at the end of treatment evaluation.
Trovagene CEO Bill Welch said: “We are encouraged by our preclinical data demonstrating that the combination of PCM-075 and Zytiga appears to enhance the PCM-075 mechanism of action of arresting cells during mitosis with subsequent tumour cell death.
“Filing our Phase II clinical trial protocol with the FDA is an important milestone towards addressing the medical need to extend the benefit of response to Zytiga in patients with mCRPC.”
The firm expects to receive the FDA approval and initiate the Phase II trial next year.
Secondary observation endpoints of the trial include effects of the combination therapy on time to prostate-specific antigen (PSA) progression, radiographic response and progression.