Protox Announces the Dosing of Patients in Transrectal Study
SAN DIEGO, CA and VANCOUVER, BC, Oct. 20, 2011 /CNW/ - 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 the first cohort of patients in its transrectal study of PRX302 for the treatment of benign prostatic hyperplasia (BPH).
"We are pleased to have initiated the study and to have completed the dosing of the first cohort of patients" said Dr. Lars Ekman, Executive Chairman and President of Protox. "The experienced team that we have put in place is well positioned to drive the development of PRX302 and its continued clinical progress".
In this US based, double-blind, multi-center, placebo controlled study, approximately 56 patients with moderate to severe BPH will be randomized to one of four planned dose cohorts. The decision to escalate dose levels will take place when all the patients in a cohort have been administered study drug in accordance with the protocol and have been followed for safety for at least 15 days post study drug administration. In this study, PRX302 is administered as a single treatment via transrectal ultrasound guided (TRUS) intraprostactic injection, the traditional route of assessment of prostate health. The primary endpoint of the study is to evaluate the 3-month safety and tolerability of escalating doses of PRX302. The safety data from this new route of administration of PRX302 will be compared with the safety profile obtained from the previously conducted Phase I and II studies utilizing a transperineal route of administration.
PRX302 is a genetically engineered version of the naturally occurring pore forming protein proaerolysin, in which the native furin cleavage and activation sequence has been replaced with a sequence that is activated by prostate-specific antigen (PSA). The replacement of the 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 forward-looking 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, 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 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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Posted: October 2011