SAN DIEGO and VANCOUVER, British Columbia, June 19, 2019 /PRNewswire/ -- Sophiris Bio
Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a
biopharmaceutical company studying topsalysin (PRX302), a
first-in-class, pore-forming protein, in late-stage clinical trials
for the treatment of patients with urological diseases, today
announced that it has received formal scientific advice from
the European Medicines Agency (EMA) regarding a proposed design of
a Phase 3 clinical trial to evaluate the potential of topsalysin as
a targeted focal therapy to treat patients with intermediate risk
localized prostate cancer.
"Based on the safety profile of topsalysin in 451 patients in
our clinical development program along with the efficacy seen in
our Phase 2 studies in localized prostate cancer, we approached the
EMA with our proposed study design for a single Phase 3 trial to
support registration in Europe,
and we are pleased to have now obtained formal feedback from the
Agency," said Randall Woods,
president and CEO of Sophiris. "We believe that data from a single
Phase 3 trial, if successful, will be sufficient to support market
approval in Europe."
The Phase 3 study design, agreed upon by the EMA, will enroll
patients with a confirmed diagnosis of intermediate risk disease.
Approximately 700 men who meet the eligibility criteria will be
equally randomized to receive a single administration of either
topsalysin or placebo. The primary endpoint for the study will be
the proportion of patients at 12 months who have failed treatment,
defined as histological progression of disease resulting in the
need for alternative intervention, per an independent central
adjudication panel.
Webcast scheduled for today at 9:30 a.m. Eastern
Time
The Sophiris management team will host a conference call and
webcast today, June 19, at 9:30 a.m. Eastern Time to
review the key details of the proposed Phase 3 clinical trial
design and to address the potential commercial opportunity for
topsalysin, along with Professor Hashim Ahmed, Faculty of
Medicine Department of Surgery & Cancer, Chair in Urology,
Imperial College of London &
Imperial College Healthcare NHS Trust and a member of the
Scientific Advisory Board at Sophiris.
A live audio webcast will be accessible on the "Investor
Relations" page of the Sophiris corporate website
at www.sophirisbio.com. A replay will be available at the
same location.
About Localized Prostate Cancer
Prostate cancer is the second most common form of cancer in men
in the United States with an
estimated 175,000 new cases in 2019. Approximately 77 percent of
patients in the United States are
diagnosed with localized disease. Research has shown that patients
with early, localized disease have a low likelihood of the cancer
spreading beyond the confines of the prostate; however, many men
with clinically-significant localized disease choose to undergo
radical treatment. Radical therapies include surgery to remove the
entire prostate and/or radiation. Potential toxicities from radical
treatments can be significant and permanent and include erectile
dysfunction, urinary incontinence and rectal toxicity.
About Topsalysin
Topsalysin (PRX302), an innovative, "First-in-Class"
transmembrane pore-forming protein, was genetically modified to be
activated only by enzymatically-active PSA, which is produced in
large quantities within the prostate of men with prostate cancer.
The targeted focal treatment of prostate cancer is in line with
current treatment trends for solid tumors such as breast and liver,
where the goal is to remove the tumor and preserve as much of the
organ and organ function as possible.
Topsalysin has the potential to provide a targeted focal therapy
for the ablation of localized prostate cancer lesions while
potentially avoiding many of the complications and side effects
associated with whole gland radical treatments. The increasing use
of multiparametric magnetic resonance imaging (mpMRI) and advances
in software to co-register previously obtained mpMRI images with
real-time three-dimensional ultrasound images enables urologists to
more accurately locate tumors within the prostate when taking
biopsies. This increases the accuracy with which men with
clinically significant lesions are identified. It also enables the
injection of an ablative agent, such as topsalysin, directly into
previously identified clinically significant tumors located within
the prostate.
About Sophiris
Sophiris Bio Inc. is a late-stage clinical biopharmaceutical
company developing topsalysin (PRX302) for the treatment of
patients with urological diseases. Topsalysin has completed two
Phase 2 clinical trials for the focal treatment of localized
prostate cancer and has completed one Phase 3 study of topsalysin
for the treatment of the lower urinary tract symptoms of benign
prostatic hyperplasia (BPH). Topsalysin is a highly potent ablative
agent that is selective and targeted in that it is only activated
by enzymatically active PSA which is found in high concentrations
in the transition zone of the prostate and in and around prostate
tumor cells. Our continuing development of topsalysin is depending
on obtaining additional financing and/or entering into partnering
or other strategic transactions. For more information, please
visit www.sophirisbio.com.
Certain statements included in this press release may be
considered forward-looking, including the quote from the CEO
and expectations about further development of topsalysin
(PRX302), plans relating to execution of a Phase 3 clinical trial
in localized prostate cancer, Sophiris' liquidity or capital
requirements and the ability to obtain additional financing or
execute other strategic alternatives. Such statements involve known
and unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements to be materially
different from those implied by such statements, and therefore
these statements should not be read as guarantees of future
performance or results. Some of the risks and uncertainties that
could cause actual results, performance or achievements to differ
include without limitation, risks associated with clinical
development, risks that the Company will be able to fund future
clinical trials or enter into a strategic transaction, risks about
the Company's ability to continue as a going concern and other
risks and uncertainties identified by Sophiris in its public
securities filings with the Securities and Exchange
Commission. All forward-looking statements are based on Sophiris'
current beliefs as well as assumptions made by and information
currently available to Sophiris and relate to, among other things,
anticipated financial performance, business prospects, strategies,
regulatory developments, clinical trial results, market acceptance,
ability to raise capital and future commitments. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Due to risks and uncertainties, including the risks and
uncertainties identified by Sophiris in its public securities
filings; actual events may differ materially from current
expectations. Sophiris disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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SOURCE Sophiris Bio Inc.
