Canada-based ESSA Pharma has started enrolling patients in its Phase I / II clinical trial of EPI-506, a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).
The trial is designed to evaluate the safety, tolerability, maximum tolerated-dose, pharmacokinetics and efficacy of EPI-506 in prostate cancer patients who have failed abiraterone or enzalutamide or both, the current standard-of-care drugs in mCRPC.
Around 150 subjects across the US and Canada will be enrolled in the trial.
According to the company, EPI-506 can significantly expand the time in which patients suffering from CRPC can benefit from hormone-based therapies.
The product acts by disrupting the androgen receptor (AR) signalling pathway, which is the primary pathway driving prostate cancer growth.
Prostate cancer is the second-most commonly diagnosed cancer among men, and the fifth most common cause of male cancer death across the world.
Adenocarcinoma of the prostate is dependent on androgen for tumour progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over six decades.
ESSA chief medical officer Dr Frank Perabo said: "Patients with metastatic CRPC who have failed abiraterone and / or enzalutamide currently represent a large unmet medical need.
"The novel mechanism of action of EPI-506 was developed specifically to overcome resistance to these current drugs."
As part of the trial, the company will collect molecular biomarker information, which may provide useful context in understanding patient outcomes.
The company noted that androgen-receptor splice variant V7 data will be included in such information.
ESSA is focused on developing therapies to treat castration-resistant prostate cancer (CRPC) in patients whose disease is progressing despite treatment with current therapies.