SAN DIEGO AND VANCOUVER, Oct. 28, 2013 /CNW/ - Sophiris Bio Inc.
(NASDAQ: SPHS) (TSX: SHS) today announced that enrollment has begun and
the first patients have been dosed in a Phase 3 trial of PRX302
(topsalysin) as a treatment for lower urinary tract symptoms of benign
prostatic hyperplasia (BPH or enlarged prostate). The Phase 3
international, multi-center study, called the PLUS-1 study, will enroll
approximately 440 patients. The randomized, double-blind and
vehicle-controlled study will assess the safety and efficacy of a
single intraprostatic injection of PRX302 (0.6 µg/g prostate) for the
treatment of BPH. The primary endpoint is the International Prostate
Symptom Score (IPSS) total score change from baseline over 52 weeks.
Secondary endpoints include Qmax change from baseline (maximum urine
flow) over 52 weeks.
PRX302 is highly targeted to prostate tissue and is delivered directly
to the prostate via a localized injection. PRX302 is designed to be at
least as efficacious as oral pharmaceuticals while being less invasive
than surgical interventions, and without the sexual side effects that
may be seen with existing treatments. In a previously completed
randomized, double-blind, vehicle-controlled Phase 2b trial, PRX302
produced sustained clinically meaningful and significant improvement in
both subjective and objective measures of BPH symptoms. In total, 126
patients with BPH have been treated with PRX302 and no drug-related
erectile dysfunction or cardiovascular side effects have been reported.
BPH is an enlarged prostate gland often resulting in a constricted or
partially blocked urethra that can lead to frequent and difficult
urination, discomfort, and other complications with urinating. It is
estimated that more than 5 million men in the United States alone are
bothered by symptoms of BPH. Current oral drugs for BPH, which are
taken daily, often lack sustainable efficacy and may be associated with
undesirable side effects including sexual dysfunction. More aggressive
treatment options include invasive surgical procedures, which may also
cause sexual dysfunction.
Sophiris Bio Inc. is a biopharmaceutical company developing a
clinical-stage, targeted treatment for the symptoms of benign prostatic
hyperplasia (BPH or enlarged prostate), which it believes is an
unsatisfied market with significant market potential. Sophiris' lead
candidate for BPH, PRX302, is designed to be as efficacious as
pharmaceuticals, less invasive than the surgical interventions, and
without the sexual side effects seen with existing treatments. For more
information, please visit www.sophiris.com.
Certain statements included in this press release may be considered
forward-looking. 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. All
forward-looking statements are based on Sophiris' current beliefs and
involve assumptions made by and information currently available to
Sophiris and relate to, among other things, risk associated with the
process of developing and commercializing treatments that are safe and
effective for use, business prospects, strategies, regulatory
developments, market acceptance and future commitments that may never
materialize or may prove to be incorrect. 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.
SOURCE: Sophiris Bio, Inc.
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