VANCOUVER and HOUSTON, April 30,
2020 /CNW/ - ESSA Pharma Inc. ("ESSA", or the
"Company") (Nasdaq: EPIX, TSX-V: EPI), a pharmaceutical company
focused on developing novel therapies for the treatment of prostate
cancer, today announced that the U.S. Food and Drug Administration
("FDA") has notified the Company that it may proceed with its
proposed clinical investigation of EPI-7386 for the treatment of
metastatic castration-resistant prostate cancer ("mCRPC"). ESSA
previously announced on March
30th, 2020 that it had filed an Investigational
New Drug ("IND") application for EPI-7386 with the FDA. EPI-7386 is
a first-in-class N-terminal domain inhibitor of the androgen
receptor.
"This is an important milestone for ESSA and we look forward to
commencing our clinical trial with EPI-7386 as a potential new
therapy for the treatment of prostrate cancer," commented
David R. Parkinson, MD, CEO of ESSA.
"The timing of this IND acceptance keeps us on track with our
initial clinical development timeline. We are working with our
initial clinical sites to ensure compliance with COVID-19 risk
management guidance as provided by the FDA as well as site
emergency plan policies to minimize any potential impact COVID-19
may have on site activation and patient enrollment."
ESSA expects the Phase 1 clinical trial to enroll approximately
18 mCRPC patients who are progressing on standard of care at
selected clinical sites, with up to 10 additional patients enrolled
in a dose expansion cohort. The study will evaluate safety
and tolerability of EPI-7386 while additionally characterizing the
pharmacokinetic, biological and anti-tumor effects of therapy. A
clinical trial application ("CTA") has been submitted to Health
Canada and is pending authorization.
About ESSA Pharma Inc.
ESSA is a 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 plans to commence a phase
1 clinical trial of EPI-7386 in the second calendar quarter of
2020.
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
regarding the expected commencement, timing and enrollment of the
Phase 1 clinical trial of EPI-7386, the potential for EPI-7386 to
be a new therapy for the treatment of prostate cancer, the
potential impact of COVID-19 and risk management measures adopted
by the Company and expectations as to the Company meeting its
initial clinical development timeline..
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 the 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