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Sophiris Bio Reports Completion of Enrollment in the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia

SAN DIEGO & VANCOUVER, British Columbia--(BUSINESS WIRE)--Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of the symptoms of benign prostatic hyperplasia (BPH, enlarged prostate) and for the treatment of localized prostate cancer, today announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH.

“We reached our targeted enrollment in this first of our Phase 3 studies on schedule”

The PLUS-1 trial is an international, multi-center, randomized, double-blind and vehicle-controlled Phase 3 study that will assess the safety and efficacy of a single intraprostatic administration 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 (maximum urine flow) change from baseline over 52 weeks.

“We reached our targeted enrollment in this first of our Phase 3 studies on schedule,” stated Randall Woods, president and chief executive officer of Sophiris. “We are on track to complete an administrative interim analysis around the end of 2014. The complete data analysis is expected to be available in the second half of 2015.”

BPH is an enlargement of the 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 five 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.

About Sophiris Bio

Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of the symptoms of BPH and treatment of localized prostate cancer. PRX302 is in Phase 3 clinical development for the treatment of the symptoms of BPH and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris plans to initiate a Phase 2 proof of concept study of PRX302 for the treatment of localized prostate cancer in the second half of 2014. For more information, please visit www.sophiris.com.

Certain statements included in this press release may be considered forward-looking, including the quote of our President and CEO and any expectations relating to our Phase 3 trial of PRX302, or the proof of concept study for the treatment of localized prostate cancer. 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, risk associated with the process of developing, obtaining regulatory approval of and commercializing treatments that are safe and effective, and in the endeavor of building a business around such treatments and risks relating to our ability to raise sufficient capital to fund these activities. 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 enrollment and results, market acceptance 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.


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