HOUSTON and VANCOUVER, BC, Sept.
14, 2020 /CNW/ - ESSA Pharma Inc. (NASDAQ: EPIX)
(TSXV: EPI) ("ESSA" or the "Company"), a clinical-stage
pharmaceutical company focused on developing novel therapies for
the treatment of prostate cancer today announced that the U.S. Food
and Drug Administration ("FDA") granted Fast Track
Designation to EPI-7386, its oral and highly-selective N-terminal
domain inhibitor of the androgen receptor, for the treatment of
adult male patients with metastatic castration-resistant prostate
cancer ("mCRPC") resistant to standard-of-care
treatment.
"We are pleased with the FDA's decision to grant Fast Track
designation for development of EPI-7386 to treat mCRPC patients
resistant to standard-of-care treatments," said Dr. David R.
Parkinson, Chief Executive Officer of ESSA Pharma. "This
designation signifies recognition of the unmet medical need for new
and effective treatments for this patient population. EPI-7386 may
represent a promising novel treatment option for these patients and
the designation offers the opportunity to interact more closely
with the FDA during the development of EPI-7386."
Fast Track is a designation granted by the FDA that is intended
to facilitate development and expedite review of drugs to address
an unmet medical need in the treatment of a serious
life-threatening condition, and for which nonclinical or clinical
data has demonstrated the potential of the drug to address this
medical need.
A drug that receives Fast track Designation is eligible for
some, or all, of the following:
- Eligibility for accelerated approval and priority review, if
relevant criteria are met
- Rolling review, enabling ESSA Pharma to submit completed
sections of its New Drug Application ("NDA") for review by
the FDA, rather than waiting until every section of the NDA is
completed before the entire application can be reviewed (NDA review
usually does not begin until the Company has submitted the entire
NDA to the FDA)
- More frequent meetings with the FDA to discuss the drug's
development plan and ensure collection of appropriate data to
support drug approval
- More frequent written communication from the FDA about such
things as the design of the proposed clinical trials and use of
biomarkers
About EPI-7386 Phase 1 Study
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. The Company filed an IND with the U.S. Food and
Drug Administration for EPI-7386 in the first calendar quarter of
2020 and clearance was received April
30,2020. A Clinical Trial Application was filed with Health
Canada in April 2020 and
authorization was received June
3rd, 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, the belief
that EPI-7386 may represent a promising novel new treatment option,
the potential benefits of the Fast Track designation including
eligibility for accelerated approval and priority FDA review,
planned enrollment of a Phase 1 study of EPI-7386, 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.
View original
content:http://www.prnewswire.com/news-releases/essa-pharma-announces-fast-track-designation-granted-by-the-fda-to-epi-7386-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-301129748.html
SOURCE ESSA Pharma Inc