Dr. Peter Pommerville, M.D., Principal Investigator from the lead site at Can-Med Clinical Research Centre (Victoria, B.C.), will present the data. The moderated poster presentation entitled “A PSA-activated Protoxin (PRX302) Administered Transperineally to Men with BPH is Well Tolerated and Induces Reduction in Prostate Volume and Symptomatic Relief”, details the 90-day results from Protox’s open-label Phase 2 BPH study. The paper concludes that PRX302 is safe and well tolerated and provides dramatic improvements in International Prostate Symptom Scores and Quality of Life, which were observed along with reductions in prostate volume.
Based on the promising results from the open-label Phase 2 study, the Company has commenced patient enrolment in a randomized, double-blinded, placebo controlled Phase 2 trial called TRIUMPH. Top-line results from TRIUMPH are expected before the end of this year.
About PRX302
PRX302 is the lead drug in the company’s PORxinTM 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 prostate cancer and BPH (benign prostatic hyperplasia or enlarged prostate). 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™ and PORxin™ 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). Final 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.
