San Diego, California and Vancouver, British Columbia, March 28, 2012 – Protox Therapeutics Inc. (“Protox”, TSX: PRX), a developer of innovative products for the treatment of urological diseases, today announced that it has completed dosing of all four cohorts of patients in its previously announced transrectal study of PRX302 for the treatment of benign prostatic hyperplasia (BPH).
The primary objective of this study is to gather safety information regarding the transrectal route of administration for the intraprostatic injection of PRX302. There were no safety issues identified by the Independent Data Monitoring Committee based on data for all patients through at least the first 15 days after dosing. Patients will continue to be followed for up to 12 months with the 3 month safety data on all patients expected in Q3 2012. “We are very pleased to have completed the enrollment of this study according to the timeline, which is an important milestone advancing the PRX302 development program.” said Dr. Lars Ekman, Executive Chairman and President of Protox.
PRX302 is a genetically engineered version of the naturally occurring pore forming protein proaerolysin. The replacement of the native activation sequence recognized by furin (found ubiquitously in mammalian cells) with one that is selectively recognized and cleaved by enzymatically active PSA, a serine protease produced only by prostate epithelial cells, has created a pathway for specific activation of the pore forming protein only within the prostate tissue (PSA found in circulation is in an inactive form). Thus once activated by PSA, PRX302 inserts itself into the membranes of cells specifically within the prostate, forming stable pores that lead to the disruption of membrane integrity, resulting in leakage of intracellular ions and ultimately cell death.
Protox Therapeutics is a developer of innovative products for the treatment of urological diseases. Protox’s lead program, PRX302 (PORxin), achieved positive results from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). Protox has partnered with Kissei Pharmaceuticals for the development and commercialization of PRX302 in Japan. For more information, please visit www.protoxtherapuetics.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 forwardlooking statements are based on Protox’ current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, closing of the Subsequent Investment, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forwardlooking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox 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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