San Diego, California and Vancouver, British Columbia, April 2, 2012 – Protox Therapeutics Inc. (TSX: PRX) announced that it has changed its name to Sophiris Bio, Inc. effective today, and the symbol “SHS” has been reserved for its use on the Toronto Stock Exchange. Trading under the new ticker symbol “SHS” is expected to commence on or about April 5, 2012.
The change is part of an operational realignment that began in 2011 led by Executive Chairman and President Lars Ekman, M.D., Ph.D., to focus on the development of a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with blockbuster potential. Sophiris, located in San Diego, has recruited a management team that has achieved more than twenty drug approvals and expects to initiate pivotal Phase 3 trials for its lead drug candidate for BPH called PRX302 before the end of 2012. “The science behind Sophiris and PRX302 is biotechnology at its finest, with a novel, highly selective approach for patients with BPH without the unwanted side effects” said Dr. Lars Ekman, Executive Chairman and President of Sophiris.
BPH is a $5 billion market with more than 4 million patients treated each year in the U.S. alone. Despite available medical treatments and surgical options, no single solution provides quick, long-term relief of symptoms without serious unwanted side effects. Pharmaceutical product sales in the U.S for BPH are $4 billion annually, however they lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH but can also result in nerve damage and sexual dysfunction.
PRX302 is designed to be a single treatment for the long-term relief of BPH symptoms, such as restricted urinary flow from enlarged prostate, without causing sexual dysfunction or sacrificing quality of life.
PRX302 is highly targeted to prostate tissue. It is delivered directly to the prostate tissue via localized injection and it is activated selectively by active Prostate Specific Antigen (PSA) found only in prostate tissue. PRX302 has shown meaningful improvements in the International Prostate Symptom Score (IPSS) and urinary flow (Qmax) at 3 and 6 months in a randomized controlled Phase IIb trial (TRIUMPH study). IPSS has been a primary endpoint and Qmax has been a secondary or co-primary endpoint for prior BPH drug approvals. To date 126 patients with BPH have been treated with PRX302, and no drug related sexual adverse events have been reported in the studies completed.
About Sophiris Bio Inc.
Sophiris is a San Diego based urology company developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), an unsatisfied market with blockbuster potential. PRX302, the company’s lead candidate for BPH, 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 is planning to begin a pivotal trial by the end of 2012. The pivotal trial is supported by a randomized, controlled Phase IIb study (TRIUMPH) that met the objective and subjective endpoints used as the basis for current BPH drug approvals. Sophiris is advised by world-leading urologists, backed by experienced investors, and led by a team that has achieved more than twenty drug approvals including several blockbusters. For more information, please visit www.sophirisbio.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 as well as assumptions made by and information currently available to Sophiris and relate to, among other things, the commencement of trading under the symbol “SHS”, results of the transrectal study, anticipated financial performance, business prospects, strategies, regulatory developments, 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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