Trovagene has started enrolling patients in a Phase II clinical trial evaluating the safety and effectiveness of PCM-075 in combination with Zytiga (abiraterone acetate) and prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The development follows an Institutional Review Board (IRB) approval granted by Dana-Farber / Harvard Cancer Center (Dana-Farber) in the US to Trovagene for the trial.
The multi-centre open-label trial is being carried out by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber, and Massachusetts General Hospital Cancer Center (MGH).
BIDMC Genitourinary Oncology Programme representative Dr David Einstein is the principal investigator of the trial, which will enrol up to 45 patients to orally administer the drug combination.
Patients will be enrolled with mCRPC who are showing signs of disease progression demonstrated by two increasing prostate-specific antigen (PSA) values separated by at least one week while on abiraterone acetate and prednisone therapy.
The primary efficacy endpoint of the trial includes the proportion of patients achieving disease control after 12 weeks of study treatment, as measured by lack of PSA progression in patients that are showing signs of early progressive disease while currently receiving abiraterone acetate and prednisone.
Dr Einstein said: “Prostate cancer will kill an estimated 29,430 men in the US this year.
“It is clear that resistance to standard therapies continues to be an urgent problem for our patients.
“Pre-clinical work has identified polo-like kinase 1 as a drug target meriting study in combination with abiraterone.”
Trovagene’s PCM-075 is a highly selective adenosine triphosphate (ATP) competitive inhibitor of serine / threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in a number of hematologic and solid tumour cancers.