VANCOUVER, Dec. 9 /CNW/ - Protox Therapeutics Inc. (the "Company" or "Protox") (TSX: PRX), a leader in the development of receptor targeted therapeutic fusion proteins, today announced publication of positive safety and efficacy results from the previously reported Phase 1 and 2 trials with PRX302 in men with moderate to severe BPH (benign prostatic hyperplasia). Senior author, Dr Sam Denmeade, together with his colleagues at Protox and Study Investigators, published the results in the Journal, European Urology.
"Having the results of our PRX302 clinical program published in a prestigious journal such as European Urology is a testament to the importance of this underserved indication and the need to advance treatments such as PRX302," said Dr. Fahar Merchant, President and CEO of Protox.
The article, entitled "Phase 1 and 2 Studies Demonstrate the Safety and Efficacy of Intraprostatic Injection of PRX302 for the Targeted Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia" is available on-line and can be viewed at:
"In these studies, intraprostatic administration of PRX302 produced an excellent safety profile with evidence of sustained relief of urinary symptoms in men with moderate to severe BPH," said Dr. Sam Denmeade, Chief Scientific Advisor of Protox. "These promising results have been further supported by a randomized BPH study showing that PRX302 produced significant improvement in urinary symptoms compared to an injected placebo. I believe that PRX302 is an exciting new approach to an extremely common problem." Dr Denmeade is co-inventor of PRX302 and Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine.
The reduction in IPSS (International Prostate Symptom Score) with PRX302 in these studies was superior in magnitude to that observed with medical therapies, which typically produce 3-6-point reductions in IPSS values. The IPSS reduction resulting from PRX302 approached that observed for minimally invasive surgical treatments (MIST), which typically reduce IPSS values by 10-12 points. Unlike MIST, PRX302 had no deleterious effect on erectile function, blood pressure spikes or the need for catheterization. Adverse events were mild to moderate and transient in nature. Ongoing follow-up of the open label and placebo controlled study patients will provide further information as to the expected duration of treatment effect on lower urinary tract symptoms associated with BPH.
PRX302 is a prostate specific antigen (PSA)-activated pore-forming protein toxin under development as a novel approach for improving lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) without affecting sexual function. PSA is a protease uniquely produced by the prostate, making PRX302 a novel, first-in-class, targeted pro-drug therapy for BPH and prostate cancer.
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 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. $4 billion of sales each year. Surgical options, including minimally invasive surgical treatments (MIST), can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require hospitalization, significant recovery time and requires catheterization for variable time intervals. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets.
Protox Therapeutics is a leader in advancing novel, receptor targeted therapeutic fusion proteins. Two drug candidates derived from the company's INxin™ and PORxin™ platforms are in clinical development. 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. PRX321 (INxin) is being developed for the treatment of various cancers and has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA for the treatment of primary brain cancer. 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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