SAN DIEGO and VANCOUVER, British Columbia, Dec. 11, 2017 /PRNewswire/ -- Sophiris Bio Inc.
(NASDAQ: SPHS) (the "Company" or "Sophiris") today announced that
it has completed enrollment in its Phase 2b study to evaluate the safety and tolerability
of topsalysin in treating men with clinically significant localized
prostate cancer. Topsalysin (PRX302) is an innovative,
first-in-class transmembrane pore-forming protein genetically
modified to be activated only in the presence of
enzymatically-active PSA, which is only found within the
prostate.
"I am delighted that Sophiris has completed enrollment into its
multi-center Phase 2b study. My
thanks to the men and my colleagues in each clinical trial center
for recognizing the potential of topsalysin to focally treat
localized, clinically significant prostate cancer with a minimally
invasive, targeted, short duration procedure," said Professor
Hashim Ahmed, Chair of
Urology, Imperial College London & Imperial College
Healthcare NHS Trust and an investigator in the study. "Over the
next few months, men in the trial will undergo follow-up biopsies
of the prostate and, if necessary, may undergo repeat topsalysin
dosing."
About the Phase 2b
Study
The Phase 2b study is a
multi-center, open-label, clinical study evaluating the safety and
efficacy of targeted intraprostatic administration of topsalysin
for the treatment of histologically proven, clinically significant,
localized prostate cancer. The study utilizes previously obtained
MRI images of each patient's prostate co-registered to real time 3D
ultrasound to target the delivery of topsalysin directly into and
around a pre-identified clinically significant tumor. The Company
expects biopsy data from all patients dosed with the first
administration of topsalysin to be available in the first half of
2018.
Importantly, the Phase 2b study
includes an option to re-treat patients with a second dose of
topsalysin, with an additional 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 clinically 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. Patients who have a
complete response to the first dose will not receive a second dose.
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"
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 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
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. 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 the Chair of
Urology, Imperial College London & Imperial College
Healthcare NHS Trust, 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
SOURCE Sophiris Bio Inc.