SAN DIEGO and VANCOUVER, British Columbia, June 8, 2017 /PRNewswire/ -- Sophiris Bio
Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris") today announced
that the first patient has been dosed in its Phase 2b study to
evaluate the safety and tolerability of topsalysin in focally
treating men with clinically significant localized prostate cancer.
Topsalysin (PRX302) is an innovative, first-in-class pore-forming
protein engineered to be activated only in the presence of
enzymatically-active PSA, which is only found within the
prostate.
This Phase 2b study will build on the successful Phase 2a
proof-of-concept study for the treatment of localized prostate
cancer which demonstrated that a targeted intraprostatic
administration of topsalysin has the potential to safely ablate
prostate tumor cells.
"Topsalysin has the potential to provide a much-needed
opportunity to treat the patients who have clinically significant
localized prostate cancer in a targeted focal manner, ablate
pre-identified lesions and downgrade the patient to non-significant
cancer," said Dr. Hashim Ahmed,
professor and chair of urology, Imperial College London. "This
would be extremely exciting and clinically meaningful for men, as
it could help them either avoid or delay the need for radical
therapies and significant side effects associated with radical
therapy."
"We have the potential to provide an efficacious, less invasive
treatment option for patients with clinically significant localized
prostate cancer," said Randall E.
Woods, president and CEO of Sophiris Bio. "Our goal with
this international Phase 2b clinical study is to confirm the dose
and optimize the delivery of topsalysin and to evaluate the safety
and efficacy of a second dose of topsalysin in a clinical
setting."
About the Phase 2b Study
The study is a multi-center, open-label, Phase 2b study
evaluating the safety and efficacy of targeted intraprostatic
administration of topsalysin for the treatment of histologically
proven, clinically significant, localized prostate cancer.
Approximately 40 patients will be enrolled in the study at multiple
sites in the United States and the
United Kingdom. The study will
utilize previously obtained MRI images of each patient's prostate
mapped to real time 3D ultrasound to target the delivery of
topsalysin directly into and around a pre-identified clinically
significant tumor. Safety and tolerability will be assessed
post-treatment over 26 weeks. Efficacy will be assessed by biopsy
and imaging (mpMRI) at 24 weeks. The Company expects to
receive six month biopsy data for all patients in the first quarter
of 2018 assuming enrollment is completed as expected.
Importantly, the Phase 2b study includes an option to re-treat
patients with a second dose of topsalysin, with a targeted biopsy
to occur six months following the second dose. In order to be
eligible for a second dose, the patient cannot have experienced a
significant adverse event attributable to topsalysin or the dosing
procedure from the first dose and the patient will need to have had
a clinical response from the first dose but still have the presence
of a clinically significant lesion area. The Company expects to
have final biopsy data on all patients who receive a second dose in
the fourth quarter of 2018.
About Localized Prostate Cancer
Prostate cancer is the second most common form of cancer in men
in the US with an estimated 161,000 new cases in 2017.
Approximately 80 percent of patients in the US 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"
pore-forming protein, was engineered to be activated only by
enzymatically-active PSA, which is produced in large quantities
exclusively 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 focal targeted therapy
for the ablation of localized prostate cancer 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
mapping 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 biopharmaceutical company developing
topsalysin (PRX302) for the treatment of patients with urological
diseases. Topsalysin is in Phase 2 clinical development for the
focal treatment of localized prostate cancer as well as Phase 3
clinical development for the treatment of 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. More than 400 patients have
received treatment with topsalysin, which continues to appear to be
safe and well tolerated. For more information, please visit
www.sophirisbio.com.
Certain statements included in this press release may be
considered forward-looking, including the quote of Sophiris'
President and CEO, expectations about clinical trial results,
including the timing of expected results and expectations about
further development of topsalysin. 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, including the risk that enrollment will not be
completed on the expected timeline, the results of the Phase 2b
study will not be available when expected and risks that the
results of the Phase 2b study will not replicate the results of the
completed Phase 2a study of topsalysin for the treatment of
localized low to intermediate risk prostate cancer or the study
endpoint[s] will not be achieved, and other risks and uncertainties
identified by Sophiris in its public securities filings with the
SEC. 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.
Company Contact:
Peter Slover
Chief Financial Officer
(858) 777-1760
Corporate Communications Contact:
Jason Spark
Canale Communications
(619) 849-6005
jason@canalecomm.com
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SOURCE Sophiris Bio Inc.