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Protox Therapeutics today announced the enrolment and successful dosing of the first patient in a Phase 2 clinical trial evaluating PRX302 to treat benign prostatic hyperplasia (BPH)
Vancouver, British Columbia, Canada | May 15, 2008 | Protox Therapeutics Inc. (TSX:PRX), a leader in the development of receptor targeted fusion proteins, today announced the enrolment and successful dosing of the first patient in a Phase 2 clinical trial evaluating PRX302 to treat benign prostatic hyperplasia (BPH), or enlarged prostate, a common and bothersome urological condition that affects over 1 million men in Canada and over 50 million men worldwide.
“This milestone sets the stage for a very exciting time for Protox this year as we embark upon dosing patients in as many as three Phase 2 clinical trials” said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. “We are very pleased with the rapid advances we have made on this important project and look forward to completing patient enrolment and releasing results before the end of this year. We believe that PRX302 has the potential of establishing a new standard of care for a disease that affects millions of men worldwide.”
BPH is characterized by difficulties in initiating or completing a urine stream and is often accompanied by painful and bothersome symptoms such as the need to wake several times during the night to urinate. Oral medications used to treat BPH can cause side effects such as sexual dysfunction and dizziness and become ineffective over time. Surgical procedures to treat males with BPH are often associated with complications and lengthy recovery times. Results from a recently completed 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.
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 (3µg/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 and prostate shrinkage at 3 months following a single treatment with PRX302.
About PRX302
PRX302 is the lead drug candidate in the company’s PORxinTM 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 mainly 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™ 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 also 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.
SOURCE: Protox Therapeutics |
