Protox Files Clinical Trial Application With Health Canada For BPH
Vancouver, British Columbia, September 21, 2006 – ProtoxTM Therapeutics Inc. (TSX-V:PRX) announced today that it has submitted a Clinical Trial Application (CTA) to Health Canada for PRX302, lead candidate in the Company’s PORxin™ technology platform. Upon clearance from Health Canada, Protox intends to commence a Phase I clinical trial of PRX302 for the treatment of benign prostatic hyperplasia (BPH), a condition commonly known as enlarged prostate.
“With this filing we continue to advance PRX302 by taking full advantage of the dramatic reduction in prostate size shown in pre-clinical studies,” said Dr. Fahar Merchant, President and Chief Executive Officer of Protox Therapeutics. “We believe that PRX302 could represent a simple, safe and effective treatment of BPH by treating the underlying cause of the condition and significantly improving the quality of life for men who suffer from this debilitating disease.”
BPH is a challenging disease to live with because it causes frequent and painful urination. Current drug treatments only address symptoms and are associated with a host of side effects including hypotension, impotence and incontinence. Despite modest therapeutic benefit, sales of drug therapies for BPH now exceed $4 billion. The most common surgical procedure for BPH – transurethral resection of the prostate (TURP) – is the second-most frequent surgical procedure in North America.
Pre-clinical studies have shown that PRX302 significantly reduces prostate size by destroying tissue in the presence of prostate specific antigen (PSA), an enzyme found at elevated levels in patients with BPH. By reducing the prostate size, pressure on the urethra is reduced thereby eliminating painful effects of the condition and restoring normal urine flow.
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 drug therapies only treat symptoms of the condition and are not curative.
About Protox
Protox Therapeutics is a product-focused clinical-stage company and a leader in advancing novel, targeted protein toxin therapeutics for treatment of cancer and other proliferative diseases. The company is actively developing two distinct but complementary platforms, INxinTM and PORxin, and currently has three clinical programs in development. PRX321 (INxin) has completed a Phase IIa clinical trial for the treatment of primary brain cancer and has received Fast Track Designation and Orphan Drug Status by the US FDA. In addition, PRX321 has also completed a Phase I study in patients with renal cell carcinoma and non-small cell lung cancer. PRX302 (PORxin) is currently enrolling patients with localized prostate cancer in a Phase I clinical trial and is also being developed for the treatment of benign prostatic hyperplasia.
NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
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
604-688-4369
aboone@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
