Protox Advances Phase I Prostate Cancer Study and Planned BPH Clinical Trial
Vancouver, British Columbia, August 10, 2006 – ProtoxTM Therapeutics Inc. (TSX-V:PRX) announced today that the first two cohorts of patients in its Phase 1 clinical trial for prostate cancer using PRX302 have been treated safely and that dose escalation to the third cohort will commence this month.
The Company also reported that the University of Vermont will participate in the clinical trial, joining Scott & White Memorial Hospital, the lead center in the trial, which began treating patients in May 2006.
“The participation of the University of Vermont and Dr. Mark Plante, the Principal Investigator, will ensure completion of patient recruitment for this trial by the end of the year,” said Dr. Fahar Merchant, President and Chief Executive Officer of Protox Therapeutics. “We look forward to reporting interim results based on a larger number of patients in the fourth quarter.”
The Phase I trial is intended to examine the safety, tolerability and therapeutic activity of PRX302 in patients with localized recurrent prostate cancer. PRX302 is injected into the prostate under sonographic guidance. Each new cohort receives a higher dose of PRX302 once safety of the drug is established in the previous cohort. Changes in PSA levels are measured and prostate biopsies are performed after 30 days to monitor therapeutic activity.
The Company today also announced the completion of a Pre-Clinical Trial Application (CTA) meeting with Health Canada regarding a planned Phase I clinical trial using PRX302 for the treatment of benign prostatic hyperplasia (BPH) or enlarged prostate. Based on feedback from Health Canada, Protox intends to submit a CTA in the third quarter of 2006.
Pre-clinical studies have shown that PRX302 can destroy prostate tissue in the presence of prostate specific antigen (PSA), an enzyme that is found at elevated levels in both BPH and prostate cancer. The purpose of the destruction is to reduce the size of the prostate and relieve the pressure exerted by the enlarged prostate on the urethra which causes a number of painful and bothersome urinary symptoms associated with the disease.
About Prostate Cancer
Prostate cancer is one of the most common malignancies in North American men. One in every six men is diagnosed with prostate cancer during their lifetime. It is estimated that during 2006 approximately 250,000 new cases of prostate cancer will be diagnosed and some 30,000 men will die from the disease throughout North America. Current treatment options for localized prostate cancer include surgery (radical prostatectomy), brachytherapy (implantation of radioactive seeds), and external beam irradiation. Serious side effects are associated with all these therapies including erectile dysfunction, incontinence and bowel problems.
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 nearly 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% may suffer from BPH after the age of 70. Current treatment includes watchful waiting, drug therapy, and surgery ranging from minimally invasive therapies to radical surgery. The most common surgical procedure performed for BPH is transurethral resection of the prostate (TURP), however all currently available therapies only treat symptoms of the condition and are not curative.
About Protox
Protox Therapeutics is a product-focused development-stage company and a leader in advancing novel, targeted protein toxin therapeutics for treatment of cancer and other proliferative diseases. The company currently has three clinical programs in various stages of development for the treatment of primary brain cancers, localized prostate cancer and cancers that over-express IL-4 receptors. The company also has a pre-clinical program for benign prostatic hyperplasia (BPH) that is expected to enter clinical trials.
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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 contact:
Anthony Boone
Director, Investor Relations and Corporate Communications
Protox Therapeutics Inc.
604-688-0199
aboone@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
