Protox Therapeutics announced today that it has completed enrollment of patients for its Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH)

VANCOUVER, CANADA | September 3, 2008 | Protox Therapeutics Inc. (TSX:PRX), a leader in the development of receptor targeted fusion proteins, announced today that it has completed enrollment of patients for its Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 1 million men in Canada and over 50 million men worldwide.

"Protox is very pleased to have completed this clinical trial ahead of schedule and looks forward to releasing top line data from this study in the fourth quarter of 2008," said Dr. Fahar Merchant, President and CEO of Protox. "The results from the company's Phase 1 BPH study demonstrated that PRX302 has an excellent safety and tolerability profile and also showed substantial symptomatic benefit in the majority of patients treated. This Phase 2 study  will provide Protox with valuable information as we continue to advance this exciting project that we believe has the potential of establishing a new standard of care for this disease."

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 and othermore 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 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 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. 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. Phase 2a clinical trials evaluating PRX302 (PORxin) for the treatment of localized prostate cancer and benign prostatic hyperplasia (enlarged prostate) are ongoing. 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.

SOURCE: Protox Therapeutics

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