SAN DIEGO and VANCOUVER, British Columbia, Oct. 21, 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 following an End of Phase 2/ Pre-Phase 3 meeting
with the United States Food and Drug Administration (FDA), there is
agreement regarding the design of a single Phase 3 clinical trial
to evaluate the potential of topsalysin as a targeted focal therapy
to treat patients with intermediate risk localized prostate
cancer.
The Phase 3 study design agreed upon with the FDA is consistent
with the design previously agreed upon with the European Medicines
Agency, as reported in June of this year. The study will enroll
approximately 700 patients with a confirmed diagnosis of localized
intermediate risk disease, to 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
therapy, as assessed by an independent central adjudication panel.
In addition, the FDA has indicated that in order to receive
approval, Sophiris will evaluate all patients that progress to
alternative treatments for an additional 12 months, for a total of
24 months of data, post the administration of study drug.
"The meeting with the FDA was positive, confirming the proposed
Phase 3 study design is an acceptable approach to targeted focal
therapy in the proposed patient population. The FDA's request to
provide data on patients progressing to alternative therapy for an
additional 12 months – for a total of 24 months – will, we believe,
strengthen the overall data package for approval, providing
valuable information on the durability of response following
targeted focal therapy with topsalysin," said 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.
"The meeting with the FDA was productive and it was clear that
if the proposed study were positive and the safety profile were to
continue as observed in clinical trials to date, a single study has
the potential to provide the clinical data to support regulatory
approval in both the US and Europe," said Professor Scott Eggener, Faculty of Surgery and
Radiobiology University of Chicago
Medicine and a member of the Scientific Advisory Board at
Sophiris.
"Now that there is a clear and agreed upon regulatory pathway
forward for localized prostate cancer, we can now focus on our plan
to fund this study and the Company going forward," said
Randall E. Woods, our president and
chief executive officer. "With the uncertainty of the regulatory
pathway removed, we are advancing our discussions with multiple
parties capable of funding the continued development of
topsalysin."
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. There is no assurance that we will
be able to enter into partnering or other strategic transactions or
obtain additional financing. For more information, please visit
www.sophirisbio.com.
Certain statements included in this press release may be
considered forward-looking, including the 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.
