Protox Initiates Phase I Study of PRX302 for Benign Prostatic Hyperplasia
- Category: Proteins and Peptides
- Published on Thursday, 29 March 2007 03:00
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VANCOUVER, Canada | Mar 28, 2007 | Protox(TM) Therapeutics Inc. (TSX-V:PRX) announced today that it has initiated a Phase 1 clinical study of PRX302 for the treatment of benign prostatic hyperplasia (BPH, commonly known as enlarged prostate) at two Canadian sites.
The Urology Associates-Urologic Medical Research center in Kitchener,
Ontario and Can-Med Clinical Research Centre in Victoria, British Columbia have been granted approval by their respective Institutional Review Boards and are now ready to begin recruiting patients. Protox had previously received authorization from Health Canada to start the study.
"We are pleased to have started this trial ahead of schedule," said Dr.
Fahar Merchant, President and CEO of Protox. "With promising interim data in prostate cancer patients, the commencement of a second trial with PRX302 in BPH positions the company as a leader in developing novel and potentially effective therapies for prostatic diseases that affect millions of men every year."
Principal investigators for the study are Dr. Russell B. Egerdie at the
Kitchener site and Dr. Peter J. Pommerville at the Victoria site. Dr. Egerdie
is the Surgical Program Medical Director and Staff Urologist at St. Mary's
General Hospital, Staff Urologist at Grand River Hospital and Adjunct
Professor of Urology at the University of Western Ontario. Dr. Pommerville is Director of Research at Can-Med Clinical Research and an active staff member at the Royal Jubilee Hospital, Victoria General Hospital and the BC Cancer Agency.
"This is an exciting and novel method for the treatment of enlargement of
the prostate gland, a condition that affects approximately a million men in
Canada," said Dr. Egerdie. "PRX302 is a new compound that may allow urologists to relieve a patient's prostatic obstruction without the need for surgery thereby avoiding the risks that are associated with surgery."
Dr. Pommerville concurred, adding, "The unique action of PRX302 could
revolutionize the treatment of benign prostatic enlargement. Men with symptoms can now be effectively treated under local anaesthesia in their urologists' office and return to work quickly. The use of PRX302 to treat histological BPH will eliminate hospital stay, reduce the morbidity of formal transurethral resection surgery and eliminate the sexual side effects common to this type of surgery."
The objective of this Phase 1 trial will be to examine the safety and
tolerability of PRX302. Secondary endpoints will include evidence of
therapeutic activity, pharmacokinetic data and antibody response to PRX302.
The study is designed to determine the therapeutic dose in male patients with symptomatic benign prostatic hyperplasia who are not currently taking oral medication for their condition. Twelve to eighteen patients are expected to take part in the open-label, dose-escalation study with each cohort of three patients receiving successively higher doses of the drug. Patients will be followed for 90 days plus three additional visits over twelve months.
Protox Therapeutics is a leader in advancing novel, targeted therapeutics for treatment of cancer and other proliferative diseases. The company is actively developing two distinct but complementary platforms, INxin(TM) and PORxin(TM), and currently has four 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 two Phase I clinical trials using PRX302 (PORxin) for prostatic disease: one to treat localized prostate cancer and the other to treat benign prostatic hyperplasia.
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% may suffer from BPH after the age of 70. Left untreated, it can result in serious and possibly irreversible bladder damage. 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 as well as other more serious procedure-related effects.
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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.
SOURCE: Protox(TM) Therapeutics Inc.