VANCOUVER, May 15 /CNW/ - Protox Therapeutics Inc. (TSX:PRX), a leader in
the development of receptor targeted fusion proteins, today announced the
enrolment and successful dosing of the first patient in a Phase 2 clinical
trial evaluating PRX302 to treat benign prostatic hyperplasia (BPH), or
enlarged prostate, a common and bothersome urological condition that affects
over 1 million men in Canada and over 50 million men worldwide.
"This milestone sets the stage for a very exciting time for Protox this
year as we embark upon dosing patients in as many as three Phase 2 clinical
trials," said Dr. Fahar Merchant, President and Chief Executive Officer of
Protox. "We are very pleased with the rapid advances we have made on this
important project and look forward to completing patient enrolment and
releasing results before the end of this year. We believe that PRX302 has the
potential of establishing a new standard of care for a disease that affects
millions of men worldwide."
BPH is characterized by difficulties in initiating or completing a urine
stream and is often accompanied by painful and bothersome symptoms such as the
need to wake several times during the night to urinate. Oral medications used
to treat BPH can cause side effects such as sexual dysfunction and dizziness
and become ineffective over time. Surgical procedures to treat males with BPH
are often associated with complications and lengthy recovery times. Results
from a recently completed Phase 1 BPH study indicate that PRX302 is safe and
well tolerated and shows very encouraging signs of therapeutic activity. The
goal of this Phase 2 study will be to optimize dosing in order to fully
exploit the therapeutic potential of PRX302, while maintaining its excellent
safety profile.
About the Phase 2 Study
In this study up to 30 patients with moderate to severe BPH will receive
a volume of PRX302 dosing solution equivalent to 10, 20 or 30 percent of the
total prostate volume. A fixed concentration of PRX302 (3(micro)g/ml) will be
delivered in 3 distinct deposition points along the urethra through a single
ultrasound-guided transperineal injection into each lobe of the prostate.
Therapeutic activity will be assessed based on symptomatic relief and prostate
shrinkage at 3 months following a single treatment with PRX302.
About PRX302
PRX302 is the lead drug candidate in the company's PORxin(TM) technology
platform. PORxin drugs are pro-drugs that are activated by specific proteases
produced at elevated levels on the surface of target cells. PRX302 has been
generated by engineering the naturally occurring toxin proaerolysin to create
a potent agent with a distinct mode of action. The drug has been engineered so
that it is activated by prostate-specific antigen (PSA), an enzyme that is
overproduced in patients suffering from prostate cancer and BPH (benign
prostatic hyperplasia or enlarged prostate). Once activated, the drug punches
holes in the target cells causing the contents to leak out and ultimately cell
death.
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 percent may suffer from BPH after the age of 70. Current drug
therapies mainly 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. According to Wood Mackenzie
(2007), the market opportunity for therapies used to treat BPH was US
$5.5 billion in drug therapies and US $4 billion in surgical procedures.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin (TM) and PORxin(TM) platforms are being developed in three clinical
programs. A Phase 2a clinical trial evaluating 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. Phase 2a
clinical trials evaluating PRX302 (PORxin) for the treatment of localized
prostate cancer and benign prostatic hyperplasia (enlarged prostate) have also
been initiated. Protox is also collaborating with the U.S. National Institutes
of Health (NIH) on a research program focused on the discovery of next
generation fully human targeted therapeutics.
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: James Beesley, Director, Investor Relations,
Protox Therapeutics, (604) 484-0975, jbeesley@protoxtherapeutics.com; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,
mmoore@equicomgroup.com
