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news.The US Food and Drug Administration (FDA) has approved ESSA Pharma's investigational new drug (IND) application to initiate a Phase 1/2 clinical study of its novel agent, EPI-506, for the treatment of metastatic castration-resistant prostate cancer ("CRPC") in patients who have failed current therapies.
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Enrolment in the clinical trial is expected to commence in the next few weeks.
In its planned Phase 1/2 clinical trial, ESSA intends to demonstrate the safety, tolerability, maximum tolerated-dose, pharmacokinetics, and efficacy of EPI-506 in treating prostate cancer patients who have failed abiraterone or enzalutamide or both, the current standard-of-care drugs in metastatic CRPC. The trial is expected to enrol approximately 150 subjects.
ESSA chief medical officer 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."
The Company also intends to seek approval from the Health Protection Branch ("HPB") in Canada to include Canadian sites in the Phase 1/2 study, and plans to file a Clinical Trial Authorization application with the HPB in order to obtain that approval.
The approval of the IND application is expected to trigger an additional $3.7 million of funding from the Cancer Prevention and Research Institute of Texas ("CPRIT").
Under ESSA’s agreement with CPRIT, a total of $12m of grant funding (repayable out of potential product revenues) will be made available to the Company, of which $2.8m has already been received. ESSA expects to receive the additional $3.7m in the next few weeks.