N@N

Protox completes enrollment of Phase 2b BPH trial

^{Published on 2009-09-08 04:11:14 - Market Wire}
 

 VANCOUVER, Sept. 8 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has completed patient enrollment in its multi-centre, double-blinded, placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. "We look forward with great anticipation, the potential to report top-line results from the TRIUMPH study before the end of 2009," said Dr Fahar Merchant, President and CEO of Protox. "This is a significant milestone for the company and we are delighted with the rapid enrollment as it underscores the enthusiasm for PRX302 among the physician and patient communities." TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study. About TRIUMPH In this multi-centre, double-blinded placebo controlled Phase 2b study, approximately 90 patients with moderate to severe BPH were randomized 2:1 (treatment : placebo). Each patient received PRX302 (3(micro)g/mL) or placebo at a volume equivalent to 20 percent of the total prostate volume. Dosing for each arm was delivered via a single ultrasound-guided injection into each lobe of the prostate. The primary objective of this study is to evaluate the efficacy of PRX302 compared to placebo as measured by the changes in IPSS (International Prostate Symptom Score) in subjects with moderate to severe BPH at 90 days post-treatment. In addition, the study will also compare efficacy of PRX302 with respect to changes from baseline in Quality of Life scores (QoL), urodynamic parameters (Qmax, PVR), proportion of responders and prostate size. The co-principal investigators of this trial are Dr Mostafa M. Elhilali, OC, M.D., Ph.D, Stephen Jarislowsky Chair in Urology at McGill University and Dr. Peter Pommerville, M.D., Director of Research at Can-Med Clinical Research Centre in Victoria, B.C. The study is being conducted at 9 sites across Canada. About PRX302 PRX302 is the lead drug in the company's PORxin(TM) technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death. About BPH BPH is a common urological condition characterized by painful and bothersome symptoms that include difficulty in initiating a urine stream, a sense of urgency, dribbling, incomplete emptying of the bladder, waking several times during the night to urinate and sometimes the presence of blood in the urine. More than half of all men will have symptoms of BPH by the age of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral therapies mainly provide symptomatic relief, may take months before they take effect and can trigger a range of side effects including sexual dysfunction and hypotension. It is estimated that in the seven largest global markets approximately 10 million men are treated annually with oral therapies and these products encompass approximately U.S. $3 billion of sales each year. Surgical options, including minimally invasive procedures, can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require significant recovery time and may require catheterization for up to several weeks post-treatment. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets. About Protox Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company's INxin(TM) and PORxin(TM) platforms are being developed in three clinical programs. Protox's lead program, PRX302 (PORxin), is currently being studied in a Phase 2b placebo controlled trial to treat benign prostatic hyperplasia (BPH or enlarged prostate). Positive Phase 2a results treating BPH patients were released at the end of 2008 and a phase 2a clinical trial evaluating PRX302 for the treatment of localized prostate cancer is ongoing. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics. 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. 

For further information: James Beesley, Senior Director, Investor Relations, Protox Therapeutics, (604) 484-0975, [ jbeesley@protoxtherapeutics.com ]; Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241, [ mmoore@equicomgroup.com ]