Protox Doses First Patient in Benign Prostatic Hyperplasia Trial using PRX302

    VANCOUVER, April 24 /CNW/ - Protox(TM) Therapeutics Inc. (TSX-V:PRX)
today announced the enrolment and successful dosing of the first patient in a
Phase I clinical study evaluating PRX302 to treat benign prostatic hyperplasia
(BPH), commonly called enlarged prostate, a disease that affects one million
Canadian men.
    "This milestone represents a significant step towards a curative
therapeutic option compared to currently available therapies," said Dr. Fahar
Merchant, President and CEO of Protox Therapeutics. "PRX302 may offer a
dramatic improvement in patient treatment and could therefore establish a new
standard of care for a disease that affects tens of millions of men
    BPH is characterized by difficulties in initiating or completing a urine
stream and is often accompanied by painful symptoms. Oral medications, which
address symptoms only, can cause unwanted side effects and become ineffective
over time. Surgical procedures to treat elderly males with BPH are associated
with complications and lengthy recovery times.
    The first patient was treated at Can-Med Clinical Research in Victoria,
British Columbia. A second clinical site has also been initiated at Urology
Associates-Urologic Medical Research in Kitchener, Ontario.
    Dr. Peter Pommerville, Principal Investigator at the Victoria site said,
"The procedure went quite smoothly taking just ten minutes to conduct, under
local anesthesia. The ease of administration means patients can resume their
normal daily routine quite quickly and, more importantly, avoid the risks
associated with surgery, notably the loss of sexual function."
    PRX302 is a pro-drug which is selectively activated by prostate specific
antigen (PSA), an enzyme produced at elevated levels in patients with BPH or
prostate cancer. Preclinical studies have shown that PRX302 can safely and
effectively reduce prostate size, potentially decreasing pressure around the
urethra and helping to restore normal urine flow. Interim results from an
on-going Phase I trial to treat patients with prostate cancer show that PRX302
is safe and well-tolerated with encouraging signs of therapeutic activity.
    In this new clinical study, PRX302 is being tested in a multi-centre,
open-label dose escalation trial among male patients with symptomatic BPH who
are not currently taking oral medication for their condition. The drug is
delivered via two intraprostatic injections delivered transperineally. The
primary objectives are to assess safety of and tolerability to PRX302 while
secondary objectives will examine therapeutic activity including impact on
symptoms and urinary flow. Up to 18 patients will be treated and actively
followed for 90 days. Patient enrolment is expected to be completed before the
end of the year.

    About Protox
    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

    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 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.


    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:

For further information: James Beesley, Director, Investor Relations,
Protox Therapeutics, (604) 688-0199,; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,

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