HOUSTON and VANCOUVER, BC, Jan. 13,
2021 /CNW/ - ESSA Pharma Inc. (Nasdaq: EPIX) ("ESSA"
or the "Company"), a clinical-stage pharmaceutical company focused
on developing novel therapies for the treatment of prostate cancer,
today announced that the Company has entered into a clinical
collaboration and supply agreement with Janssen Research &
Development, LLC (Janssen) to evaluate ESSA's first-in-class
N-terminal domain androgen receptor inhibitor, EPI-7386, in
combination with apalutamide as well as the combination of EPI-7386
with abiraterone acetate plus prednisone in patients with
metastatic castration-resistant prostate cancer ("mCRPC").
Under the terms of the agreement, Janssen may sponsor and
conduct up to two Phase 1/2 studies evaluating the safety,
tolerability and preliminary efficacy of the combination of
EPI-7386 and apalutamide as well as the combination of EPI-7386
with abiraterone acetate plus prednisone in patients with mCRPC who
have failed a current second-generation antiandrogen therapy.
Janssen will assume all costs associated with the studies, other
than the manufacturing costs associated with the clinical drug
supply of EPI-7386. The parties will form a joint oversight
committee for the clinical studies, which are planned to start in
2021. ESSA will retain all rights to EPI-7386.
"We are delighted to collaborate with Janssen to explore the
potential clinical role of EPI-7386 in combination with the
antiandrogens apalutamide and abiraterone acetate plus prednisone
in patients with metastatic castration-resistant prostate cancer,"
said Dr. David. R. Parkinson, Chief Executive Officer, ESSA Pharma
Inc. "EPI-7386 binds to the androgen receptor targeting the
opposite end of the androgen receptor from current therapies. In
preclinical models, we have seen that combining EPI-7386 with
current antiandrogens can lead to deeper and broader inhibition of
androgen biology. We look forward to investigating these
combination therapies and their potential to improve the treatment
of prostate cancer."
About EPI-7386
EPI-7386 is an investigational,
highly-selective, oral, small molecule inhibitor of the N-terminal
domain of the androgen receptor. EPI-7386 is currently being
studied in a Phase 1 clinical trial (NCT04421222) in men with
metastatic castration-resistant prostate cancer ("mCRPC") whose
tumors have progressed on current standard-of-care therapies. The
Phase I clinical trial of EPI-7386 began in Q3 of 2020 following
FDA allowance of the IND and Health Canada acceptance. The U.S. FDA
has granted Fast Track designation to EPI-7386 for the treatment of
adult male patients with mCRPC resistant to standard-of-care
treatment. ESSA retains all rights to EPI-7386 worldwide.
About ESSA Pharma Inc.
ESSA is a clinical-stage
pharmaceutical company focused on developing novel and proprietary
therapies for the treatment of patients with prostate cancer. 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 can lead to metastatic
castration-resistant prostate cancer ("mCRPC"). The treatment of
mCRPC patients has evolved rapidly over the past ten years. Despite
these advances, many patients with mCRPC fail or develop resistance
to existing treatments, leading to continued disease progression
and limited survival rates.
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 sponsorship by Janssen of up to two Phase 1/2
studies, Janssen's assumption of all costs associated with the
studies, the formation of a joint oversight committee, the
anticipated start date in 2021 of the clinical studies 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 10-K dated December 15, 2021 under the heading "Risk
Factors", a copy of which is available on ESSA's profile on
EDGAR at www.sec.gov, and as otherwise disclosed from time to time
on ESSA's SEDAR profile www.sedar.com.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.
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