VANCOUVER, March 28 /CNW/ - 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
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
"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
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
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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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
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acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
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whether as a result of new information, future events or otherwise.
For further information:
For further information: James Beesley, Director, Investor Relations,
Protox Therapeutics, (604) 688-0199, firstname.lastname@example.org; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,