VANCOUVER, April 8 /CNW/ - Protox Therapeutics Inc. (TSX:PRX - News), a leader in the development of receptor targeted fusion proteins, today announced that the Company has received Institutional Review Board (IRB) and Health Canada approvals to proceed with its Phase 2 clinical trial evaluating PRX302 for the treatment of benign prostatic hyperplasia (BPH). Activities associated with patient screening have commenced and the Company expects to enroll the first patient during the second quarter of 2008.
Results from the Phase 1 BPH study indicate that PRX302 is safe and well tolerated and shows very encouraging signs of therapeutic activity. The goal of this Phase 2 study will be to optimize dosing in order to fully exploit the therapeutic potential of PRX302, while maintaining its excellent safety profile.
“This is a significant milestone for the company and we look forward to building upon the very promising results that we released from the Phase 1 BPH study earlier this year,” said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. “We believe that PRX302 represents a significant opportunity for the treatment of BPH, a disease that impacts the quality of life of over 1 million men in Canada and over 50 million men worldwide.”
About the Phase 2 Study
In this study up to 30 patients with moderate to severe BPH will receive a volume of PRX302 dosing solution equivalent to 10, 20 or 30 percent of the total prostate volume. A fixed concentration of PRX302 (3(micro)g/ml) will be delivered in 3 distinct deposition points along the urethra through a single ultrasound-guided transperineal injection into each lobe of the prostate. Therapeutic activity will be assessed based on symptomatic relief, prostate shrinkage and uroflow measurements at 3 months following a single treatment with PRX302.
About PRX302
PRX302 is the lead drug candidate in the company’s PORxin(TM) technology platform. PORxin drugs are 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 to create a potent agent with a distinct mode of action. The drug has been engineered 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 target 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, leaking, dribbling and presence of blood in the urine. The condition affects over 50 million men throughout North America, Europe and Japan. More than half of all men will have symptoms of BPH by age 60 and as many as 90 percent may suffer from BPH after the age of 70. Current drug therapies only provide symptomatic relief and may trigger a range of side effects including impotence and hypotension. Surgical options such as TURP (transurethral resection of the prostate), which constitute the second-largest item in the US Medicare budget, can cause impotence, incontinence as well as other more serious procedure-related effects. According to Wood Mackenzie (2007), the market opportunity for therapies used to treat BPH was US $5.5 billion in drug therapies and US $4 billion in surgical procedures.
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 platforms are being developed in three clinical programs. 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. Phase 2a clinical trials evaluating PRX302 (PORxin) for the treatment of localized prostate cancer and benign prostatic hyperplasia (enlarged prostate) have been initiated. 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, 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
Source: Protox Therapeutics Inc.
