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Protox Receives Approval from Health Canada for BPH Clinical Trial

Vancouver, British Columbia, October 11, 2006 – ProtoxTM Therapeutics Inc. (TSX-V:PRX) announced today that it has received approval of their Clinical Trial Application (CTA) from Health Canada to initiate a Phase I human clinical trial of PRX302 to treat adult men with benign prostatic hyperplasia (BPH), or enlarged prostates.

“This approval marks another major milestone for the Company and we are hopeful that PRX302 will be the first drug to target what is believed to be the root cause of BPH, instead of only treating the symptoms” said Dr. Fahar Merchant, President and CEO of Protox. “PRX302 could represent a revolutionary new approach to treating a condition that affects millions of men who suffer from this disease.”

BPH is a condition in which the prostate gland becomes enlarged, placing increased pressure around the urethra resulting in difficult and painful urinary flow. Over half of all men over the age of 60 will experience symptoms of BPH and up to 90% of men over the age of 70 suffer from symptoms of BPH. Current drug and surgical therapies for BPH are not very effective, often having slow onset and with side effects such as decreased libido, sexual dysfunction, incontinence, hypotension and/or surgical complications.

PRX302 is a targeted toxin-based therapy that destroys diseased cells without harming surrounding healthy tissue. The pro-toxin is delivered directly into the prostate, using a minimally invasive technique, where it is activated by prostate specific antigen (PSA), an enzyme overproduced in men with BPH and prostate cancer. Once activated, the drug forms pores on the cell’s surface, through which the contents leak out causing the cell to die.

In addition to determining safety and tolerability of PRX302, the planned Phase I clinical trial will also investigate the effects of PRX302 on clinically important parameters, including impact on symptoms, prostate volume, PSA levels, urinary flow and change in post-void residual volume of urine. Pre-clinical studies have shown that PRX302 dramatically reduces prostate size. Decrease in prostate size may reduce the pressure around the urethra and possibly restore normal urine flow. In addition to BPH, the Company is also developing PRX302 for the treatment of prostate cancer and plans to announce interim results from the Phase 1 prostate cancer trial later this year.

About BPH
Benign prostatic hyperplasia (BPH), also known as enlargement of the prostate, is the most common urological problem among older men and affects over 50 million men throughout North America, Europe and Japan. BPH can restrict the flow of urine, resulting in urine retention and weakening of the bladder wall due to an inability to empty the bladder completely. The painful and bothersome symptoms of BPH include difficulty in initiating a urine stream, a sense of urgency, frequent urination, repeated awakening at night to urinate, and even leaking, dribbling and presence of blood in the urine. It can also be progressively severe, with the risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. In some cases, if left untreated, BPH may develop into prostate cancer. It is estimated that current annual sales of drug therapies used to treat BPH exceed $2.5 billion

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, INxin™ and PORxin™, and currently has three clinical programs in development. A Phase IIa clinical trial into the use of 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. In addition, a Phase I trial has been completed for PRX321 to treat patients with renal cell carcinoma and non-small cell lung cancer. Patient enrolment is underway for a Phase I clinical study into the use of PRX302 (PORxin) to treat localized prostate cancer. A clinical program is also being developed for PRX302 to treat benign prostatic hyperplasia (BPH).

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 visit our website at www.protoxtherapeutics.com, or 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

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February 4, 2010
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Events

January 11, 2010 - 8:45 am ET
Protox Therapeutics Conference Call - Webcast Link

 

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