Canada-based ESSA Pharma has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin a Phase I/II clinical trial of its new agent, EPI-506, to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have not responded to current therapies.
The company intends to begin patient enrolment in Phase I/II trial in the next few weeks.
Around 150 subjects are expected to be enrolled in the trial, which is designed to evaluate the safety, tolerability, maximum tolerated-dose, pharmacokinetics and efficacy of EPI-506 in treating prostate cancer patients who have failed abiraterone or enzalutamide, the current standard-of-care drugs in metastatic CRPC.
ESSA chief medical officer Dr Frank Perabo said: "We are excited to initiate this clinical trial with EPI-506.
"The novel mechanism of action of EPI-506 holds high potential to successfully treat prostate cancer patients who have failed existing therapies."
In addition, the company intends to seek approval from the Canada’s Health Protection Branch (HPB) to include Canadian sites in the trial, as well as plans to file a Clinical Trial Authorization application with the HPB in order to secure that approval.
According to the company, the IND approval is expected to trigger additional funds of about $3.7m from the Cancer Prevention and Research Institute of Texas (CPRIT).
Under its agreement with CPRIT, a total of $12m of grant funding (repayable out of potential product revenues) will be made available to the company, with $2.8m of this having already been received.
The additional funding of $3.7m is expected to be received in the next few weeks.
According to the company, EPI-506 can significantly expand the interval of 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 that drives prostate cancer growth.