2015-09-23 16:30 ET - News Release
Dr. Frank Perabo reports
ESSA PHARMA INC. RECEIVES FDA APPROVAL TO COMMENCE CLINICAL DEVELOPMENT
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
"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.
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.
We seek Safe Harbor.