HOUSTON, TX and VANCOUVER,
Nov. 24, 2015 /PRNewswire/ - ESSA
Pharma Inc. ("ESSA" or the "Company") (TSX: EPI; NASDAQ: EPIX)
announced today that the first patient has been enrolled in ESSA's
Phase 1/2 clinical study of EPI-506 as a treatment for metastatic
castration-resistant prostate cancer ("mCRPC").
In the Phase 1/2 clinical trial, ESSA intends to demonstrate 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. The trial is expected to enroll approximately
150 subjects across the United
States and Canada.
"Patients with metastatic CRPC who have failed abiraterone
and/or enzalutamide currently represent a large unmet medical
need," said Dr. Frank Perabo, ESSA's
Chief Medical Officer. "The novel mechanism of action of EPI-506
was developed specifically to overcome resistance to these current
drugs."
As part of the clinical study, ESSA will collect molecular
biomarker information which may provide useful context in
understanding patient outcomes. Androgen receptor splice
variant V7 data will be included in such information.
Details relating to the Phase 1/2 clinical trial are now
available on the US National Institutes of Health clinical trials
website (https://clinicaltrials.gov).
About ESSA Pharma Inc.
ESSA Pharma is a clinical-stage pharmaceutical company focused
on developing novel and proprietary therapies for the treatment of
castration resistant prostate cancer ("CRPC") in patients whose
disease is progressing despite treatment with current therapies.
ESSA believes that its product candidate, EPI-506, can
significantly expand the interval of time in which patients
suffering from CRPC can benefit from hormone-based therapies.
EPI-506 acts by disrupting the androgen receptor ("AR") signaling
pathway, which is the primary pathway that drives prostate cancer
growth. We have shown that EPI-002, the primary metabolite of
EPI-506, prevents AR activation by binding selectively to the
N-terminal domain ("NTD") of the AR. A functional NTD is essential
for activation of the AR. Blocking the NTD prevents activation of
the AR by all of the three known mechanisms of activation. In
pre-clinical studies, blocking the NTD has demonstrated the
capability to overcome the known AR-dependent mechanisms of CRPC.
ESSA was founded in 2009 and is located in Vancouver, British Columbia and Houston Texas.
About Prostate Cancer
Prostate cancer is the second-most commonly diagnosed cancer
among men and the fifth most common cause of male cancer death
worldwide (Globocan, 2012). Adenocarcinoma of the prostate is
dependent on androgen for tumor progression and depleting or
blocking androgen action has been a mainstay of hormonal treatment
for over six decades. Although tumors are often initially sensitive
to medical or surgical therapies that decrease levels of
testosterone (for example, ADT), disease progression despite
castrate levels of testosterone generally represents a transition
to the lethal variant of the disease (mCRPC) and most patients
ultimately succumb to the illness. The treatment of mCRPC patients
has evolved rapidly over the past five years; despite these
advances, additional treatment options are needed to improve
clinical outcomes in patients, particularly those who fail existing
treatments including abiraterone or enzalutamide, or those that
have contraindications to receive those drugs. Over time, patients
with mCRPC generally experience continued disease progression,
worsening pain, leading to substantial morbidity and limited
survival rates. In both in vitro and in vivo studies, ESSA's novel
approach to blocking the androgen pathway has been shown to be
effective in blocking tumor growth when current therapies are no
longer effective.
Forward-Looking Statement Disclaimer
This release contains certain information which, as
presented, constitutes "forward-looking information" within the
meaning of applicable Canadian securities laws. Forward-looking
information involves statements that relate to future events and
often addresses expected future business and financial performance,
containing words such as "anticipate", "believe", "plan",
"estimate", "expect", and "intend", statements that an action or
event "may", "might", "could", "should", or "will" be taken or
occur, or other similar expressions and includes, but is not
limited to, statements about the Company's upcoming Phase 1/2
clinical trial; receipt of CPRIT funds; and the implementation of
the Company's business model and strategic plans.
Forward-looking statements and information are subject to
various known and unknown risks and uncertainties, many of which
are beyond the ability of ESSA to control or predict, and which may
cause ESSA's actual results, performance or achievements to be
materially different from those expressed or implied thereby. Such
statements reflect ESSA's current views with respect to future
events, are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while
considered reasonable by ESSA as of the date of such statements,
are inherently subject to significant medical, scientific,
business, economic, competitive, political and social uncertainties
and contingencies. In making forward looking statements, ESSA may
make various material assumptions, including but not limited to (i)
obtaining positive results of clinical trials; (ii) obtaining
regulatory approvals; and (iii) general business, market and
economic conditions.
Forward-looking information is developed based on assumptions
about such risks, uncertainties and other factors set out herein
and in ESSA's prospectus dated December 5,
2014 under the heading "Risk Factors", a copy of which is
available on ESSA's profile at the SEDAR website at www.sedar.com,
and as otherwise disclosed from time to time on ESSA's SEDAR
profile. Forward-looking statements are made based on management's
beliefs, estimates and opinions on the date that statements are
made and ESSA undertakes no obligation to update forward-looking
statements if these beliefs, estimates and opinions or other
circumstances should change, except as may be required by
applicable Canadian securities laws. Readers are cautioned against
attributing undue certainty to forward-looking statements.
SOURCE ESSA Pharma Inc