VANCOUVER and HOUSTON, March 31,
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 it has submitted an Investigational New Drug
(IND) application to the U.S. Food and Drug Administration (FDA) to
evaluate its lead clinical candidate, EPI-7386, in a Phase 1
clinical study for the treatment of patients with metastatic
castration-resistant prostate cancer (mCRPC).
"We believe that EPI-7386 has the potential to be an important
new therapy for men with prostate cancer. All of the preclinical
data accumulated to date leads us to believe that it will be an
active agent with a good PK profile," commented David R. Parkinson, MD, CEO of ESSA. "We
remain focused on conducting a clinical trial of this unique
inhibitor of the N-terminal domain of the androgen receptor in
adult male patients with mCRPC resistant to standard of care
treatments. We are pleased that we were able to file the IND as
planned. This is a significant milestone for the Company and we
look forward to beginning clinical testing of EPI-7386 in patients
as soon as possible."
The Company also provided a business update as the COVID-19
situation rapidly evolves. To date, the global coronavirus outbreak
has not had a material impact on the Company's business
operations. At present, ESSA does not anticipate changes to
planned achievement of key clinical milestones in calendar year
2020, but is continuing to monitor the situation.
Business Updates:
- We remain on track to commence the monotherapy clinical study
of EPI-7386 in mCRPC patients resistant to standard of care
treatments in Q2 2020.
- Enrollment will be approximately 18 patients at multiple US and
Canadian medical institutions in a standard 3+3 trial design with
up to 10 additional patients enrolled in the dose expansion
cohort.
- Clinical sites are being finalized and we are preparing for
clinical trial initiation. We are working with our contract
research organization ("CRO") to prepare for clinical trial
initiation, despite the current limitations on travel. We will also
augment our trial risk management plan including mitigation
strategies to deal with clinical trial sites that may be impacted
by the COVID-19 situation. This plan will incorporate the latest
FDA guidance regarding clinical trial conduct during the COVID-19
pandemic.
- Although our in-person lab activities are affected by COVID-19,
we have conducted extensive gene expression studies demonstrating
differentiation of our N-terminal domain (NTD) inhibition mechanism
from ligand binding domain (LBD) inhibition by anti-androgens as
well as the unique quantitative and qualitative effects of the
combination of NTD and LBD androgen receptor inhibition. The full
analysis of these results will be presented at a future scientific
meeting.
- The Company ended December 31,
2019 with $45.9 million cash,
which we believe provides operating funds through fiscal year end
2022 (September 30) and will allow
ESSA to complete the Phase 1 monotherapy dose-escalation study, an
expansion phase to that study, and a combination study of EPI-7386
with currently utilized antiandrogens in metastatic prostate cancer
patients with earlier stages of the disease.
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 filed an IND with the U.S.
Food and Drug Administration ("FDA") for EPI-7386 in the first
calendar quarter of 2020. 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
regarding the preparation and expected timing of a Phase 1 study of
EPI-7386, a combination study of EPI-7386 and other statements
surrounding the Company's clinical evaluation of, and beliefs with
respect to, EPI-7386, as well as statements regarding the Company's
liquidity profile and the impact of the global coronavirus outbreak
on the Company's operations.
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