SAN DIEGO and VANCOUVER, British Columbia, Aug. 29, 2018 /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 the
conclusion of the ongoing investigation into the previously
reported death of a patient in the Company's Phase 2b trial for the treatment of localized prostate
cancer is unlikely to be related to either topsalysin or the
procedure. The regulatory authorities in the United States and the United Kingdom where the study is being
conducted have been notified.
Following a comprehensive review of the recently received
autopsy report, together with hospital records and the negative
serology results for acute hypersensitivity, the Investigator and
Company believe that the cause of death is consistent with the
autopsy finding of Sudden Cardiac Death (SCD) probably due to an
arrhythmia. The autopsy found that the patient had multiple risk
factors for SCD. The investigator and the Company concur that the
event is unlikely related to topsalysin or the procedure.
"As we have previously reported, over 450 patients have received
topsalysin at various doses. Topsalysin continues to appear to be
well-tolerated with no new safety signals reported," said
Randall E. Woods, President and
Chief Executive Officer of Sophiris. "We are very encouraged with
the results from the single administration of topsalysin in our
Phase 2b study that were reported in
June 2018. We continue to plan and
move forward with a potential Phase 3 study design based on the
response rates and safety profile we have observed to date. We look
forward to reporting the complete efficacy and safety data from the
Phase 2b study by the end of the year
which will include the biopsy and safety data from the 10 patients
who received a second administration of topsalysin."
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 450 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 quotes of Sophiris'
President and CEO and expectations about further development of
topsalysin (PRX302), including the timing of expected results, the
expected safety or efficacy results for the full study, the
administration of a second dose and plans relating to the design
and execution of a Phase 3 clinical trial. 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 results of the final Phase
2b study will not be available when
expected, risks that the administration of a second dose will not
be included in further development, risk that the study endpoint[s]
will not be achieved, risks relating to the design of a possible
Phase 3 clinical trial, risks that the manufacturing of clinical
drug supply for Phase 3 clinical trials will not be completed when
expected or at the expected costs, risks that the Company will be
able to fund future clinical trials 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 and Media
Contact:
Jason Spark
Canale Communications
(619) 849-6005
jason@canalecomm.com
Investor Contact:
Bill
Slattery, Jr.
Burns McClellan
(212) 213-0006
bslattery@burnsmc.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/sophiris-bio-updates-on-phase-2b-localized-prostate-cancer-trial-300703992.html
SOURCE Sophiris Bio Inc.