SAN DIEGO and VANCOUVER, British Columbia, Oct. 2, 2017 /PRNewswire/ -- Sophiris Bio
Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris") today provided an
update on clinical trial enrollment of its Phase 2b study of
topsalysin as a treatment for men with clinically significant
localized prostate cancer. Patient enrollment is near completion,
and the remaining patients are being scheduled to receive treatment
within the next few weeks. Sophiris expects the study will be fully
enrolled by the end of October. The Company expects biopsy data
from all patients dosed with the first administration of topsalysin
to be available late in the first quarter of 2018.
"Interest in this study has been strong, and the remaining
patients are being scheduled for treatment in the next few weeks,"
said Randall E. Woods, president and
CEO of Sophiris. "We look forward to completing enrollment, and,
assuming enrollment is completed as expected, initial biopsy
results will be available toward the end of the first quarter of
2018."
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 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
View original content with
multimedia:http://www.prnewswire.com/news-releases/sophiris-bio-provides-enrollment-update-on-topsalysin-phase-2b-study-in-localized-prostate-cancer-300528874.html
SOURCE Sophiris Bio Inc.