SAN DIEGO & VANCOUVER, British Columbia -- (BUSINESS WIRE) -- 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.