HOUSTON and VANCOUVER, BC, July 15,
2020 /CNW/ - ESSA Pharma Inc. (Nasdaq: EPIX) (TSXV:
EPI), a clinical-stage pharmaceutical company focused on developing
novel therapies for the treatment of prostate cancer, today
announced the first patient dosed in a Phase 1 clinical trial
designed to demonstrate the safety and tolerability of EPI-7386 in
metastatic castration-resistant prostate cancer ("mCRPC") patients
who failed standard of care treatments, including second generation
anti-androgens. EPI-7386 is a small molecule inhibitor of the
N-terminal domain of the androgen receptor (AR) which has shown
preclinical activity in both anti-androgen sensitive and
anti-androgen resistant prostate cancer
models.
"The initiation of this study represents a significant milestone
for ESSA as it brings us a step closer to offering a potentially
meaningful new therapeutic option to prostate cancer patients,"
said Dr. David Parkinson MD, Chief
Executive Officer of ESSA. "The fact that EPI-7386 was first
synthesized less than two years ago and yesterday began dosing in
patients is a testament to the efficiency of our team and our
collaborators". Dr. Parkinson continued, "The results from this
trial will guide our future development plans and confirm the
potential contribution of N-terminal domain AR inhibition to the
treatment of prostate cancer".
The Phase 1 clinical trial (NCT04421222) expects to enroll
approximately 18 mCRPC patients in the dose escalation part of the
study at selected clinical sites in the
United States and Canada,
with an additional ten patients planned to be enrolled in a dose
expansion cohort involving additional clinical sites. The study
will evaluate the safety and tolerability of EPI-7386 while
additionally characterizing the pharmacokinetic, biological and
anti-tumor effects of therapy.
About ESSA Pharma Inc.
ESSA is a clinical-stage
pharmaceutical company focused on developing novel and proprietary
therapies for the treatment of castration-resistant prostate cancer
in patients whose disease is progressing despite treatment with
current therapies. ESSA's proprietary "aniten" compounds bind to
the N-terminal domain of the androgen receptor ("AR"),
inhibiting AR driven transcription and the AR signaling pathway in
a unique manner which bypasses the drug resistance mechanisms
associated with current anti-androgens. The Company is currently
conducting a phase 1 study of EPI-7386 in patients with mCRPC who
are failing current standard-of-care therapies. For more
information, please visit www.essapharma.com and follow us on
Twitter under @ESSAPharma.
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, 2018).
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, 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 who 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 animal 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 the
Private Securities Litigation Reform Act of 1995 and/or 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
that the Company is a step closer to offering a potentially
meaningful new therapeutic option to prostate cancer patients with
few treatment options, as to the potential results of a clinical
study of EPI-7836 and enrollment particulars and other statements
surrounding the Company's clinical evaluation of EPI-7386.
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)
the accuracy of ESSA's financial projections; (ii) obtaining
positive results of clinical trials; (iii) obtaining necessary
regulatory approvals; and (iv) 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 Annual Report on Form 20-F dated December 19, 2019 under the heading "Risk
Factors", a copy of which is available on ESSA's profile on the
SEDAR website at www.sedar.com, ESSA's profile on EDGAR at
www.sec.gov, 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 and United
States securities laws. Readers are cautioned against
attributing undue certainty to forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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SOURCE ESSA Pharma Inc