VANCOUVER, Jan. 15 /CNW/ - Protox Therapeutics Inc. (TSX-V:PRX), a leader
in the development of targeted therapeutic proteins, today announced that the
Company has received Institutional Review Board (IRB) approvals to proceed
with its Phase 2a clinical trial evaluating PRX302 for the treatment of
localized recurrent prostate cancer. Activities associated with patient
screening have commenced and the Company expects to enroll the first patient
in the first quarter of 2008.
"This is the first of three Phase 2 trials planned to commence this
year," said Dr. Fahar Merchant, President and CEO of Protox. "The Phase 2a
study will enable us to build upon the favourable results from our recently
completed Phase 1 studies and allow us to develop the most effective
development strategy to support commercialization of PRX302."
PRX302, a targeted PSA activated pore-forming pro-toxin, has shown
promising signs of clinical and biologic activity in two Phase 1 trials. The
goal of this Phase 2a study will be to optimize dosing in order to fully
exploit the therapeutic potential of PRX302, while maintaining its excellent
"The impressive results reported earlier on the Phase 1 studies provides
us with the confidence that PRX302 represents a significant opportunity for
the treatment of not only prostate cancer, but also BPH," commented Dr. Samuel
Denmeade, Chief Scientific Officer of Protox and co-inventor of PRX302.
About the Phase 2a Study
A total of up to 30 patients with recurrent localized prostate cancer
following primary radiation therapy will be enrolled in this Phase 2a,
single-arm, open-label, multi-centre study. The trial is designed to determine
the optimal injection regimen that provides the maximal therapeutic benefit,
while maintaining safety and tolerability of a single intra-prostatic
treatment of PRX302. By increasing the volume and/or number of deposits, it is
anticipated that the treatment effects of PRX302 may extend to larger volumes
of the prostate and, consequently, enhance its therapeutic activity. Measure
of therapeutic activity will be based on changes in PSA levels, PSA doubling
time and tumour burden.
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
About Prostate Cancer
Prostate cancer is a leading cause of cancer death in North American men.
One in every six men is diagnosed with prostate cancer during their lifetime.
The American Cancer Society estimates that during 2007 approximately 219,000
new cases of prostate cancer will be diagnosed and over 27,000 men will die
from the disease in the U.S. Current treatment options for localized prostate
cancer include surgery and radiation therapy. Serious side effects are
associated with these therapies including erectile dysfunction, incontinence,
urinary dysfunction and bowel problems.
Protox Therapeutics is a leader in advancing novel, targeted protein
toxin therapeutics for the treatment of cancer and other proliferative
diseases. 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. Patient enrollment for a
Phase 2a study evaluating PRX302 for the treatment of localized prostate
cancer is underway, while patient enrollment for a Phase 2 study evaluating
PRX302 for the treatment of benign prostatic hyperplasia (enlarged prostate)
is due to commence in the first quarter of 2008.
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:
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,