ESSA PHARMA INC. RECEIVES FDA APPROVAL

Essa receives FDA approval for EPI-506 phase 1/2 trial

2015-09-23 16:30 ET - News Release

Dr. Frank Perabo reports
ESSA PHARMA INC. RECEIVES FDA APPROVAL TO COMMENCE CLINICAL DEVELOPMENT
The U.S. Food and Drug Administration (FDA) has approved Essa Pharma Inc.'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. 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 enroll approximately 150 subjects.

"We are excited to initiate this clinical trial with EPI-506," said Dr. Frank Perabo, Essa's chief medical officer. "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 financing from the Cancer Prevention and Research Institute of Texas (CPRIT). Under Essa's agreement with CPRIT, a total of $12-million of grant financing (repayable out of potential product revenues) will be made available to the company, of which $2.8-million has already been received. Essa expects to receive the additional $3.7-million in the next few weeks.
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