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Protox receives FDA clearance to begin Phase I prostate cancer trial
Monday, January 16, 2006 - Vancouver, British Columbia - Protox Therapeutics
Inc. announced today that the Investigational New Drug (IND) application for
PRX302, the Company’s lead product for the treatment of recurrent localized
prostate cancer, has been cleared by the US Food and Drug Administration (FDA).
As reported previously, the IND application was filed in December, 2005 and
its clearance means that the Company may now proceed with the initiation of
its Phase I clinical trial. PRX302 is the first of a novel class of targeted
prodrugs based on the Company’s PORxin™ platform. It is a therapeutic
pore-forming toxin designed to be activated by prostate specific antigen (PSA),
an enzyme which is produced and is active only in the prostate.
“Receiving FDA approval to proceed with our first Phase I clinical trial
is a significant and exciting milestone for the growth of Protox and its clinical
development programme,” stated Dr. Fahar Merchant, President and CEO
of Protox. " This milestone underscores the potential therapeutic benefit
of our targeted PORxin™ platform originally developed by Dr. Tom Buckley,
our Chief Scientific Officer.”
Dr. Merchant added that, “our ability to successfully reach this important
goal was due to the commitment and considerable effort by Rosemina Merchant,
our Vice President for Development and Regulatory Affairs, and the support
from our development partners. We expect to leverage our advances with PRX302
to file an additional IND this year for the treatment of benign prostatic
hyperplasia (BPH or enlarged prostate), an indication that is not adequately
served by current treatments.”
The Phase I clinical trial will be an open-label, dose-escalation study of
PRX302 in patients with locally recurrent prostate cancer. Patient enrollment
will commence in the next few weeks. The Phase I trial will be conducted at
Scott & White Memorial Hospital in Temple, Texas and at least one additional
site in the United States. The trial is expected to enroll approximately 24
patients and has been designed to determine safety, tolerability and therapeutic
activity of PRX302.
About Prostate Cancer
Prostate cancer is one of the most common malignancies in North American men.
It is estimated that nearly 250,000 men in North America will be diagnosed
with prostate cancer this year. Every year, more then 30,000 men die of prostate
cancer in the US alone.
Current treatment options for localized prostate cancer include surgery (radical
prostatectomy), brachytherapy (implantation of radioactive seeds), and external
beam irradiation. Unfortunately each of these therapies can result in erectile
dysfunction, incontinence, urinary toxicity and rectal toxicity. PRX302 is
being developed for the treatment of localized recurrent prostate cancer.
At present there are no licensed drugs available for salvage therapy of purely
local recurrence of prostate cancer.
About Protox Therapeutics
Protox Therapeutics Inc. is developing novel targeted cancer therapeutics
based on engineered protein toxins. Its lead programme (PORxin™) is based
on pore forming protoxins such as modified proaerolysin. PORxins™ are
inactive pro-drugs that are preferentially activated at the tumour site into
potent toxins by cancer specific proteases, thereby causing cancer cell death.
The Company works in partnership with research groups at the University of
Victoria, Johns Hopkins University, Scott & White Hospital and other research
institutions.
For more information, contact:
Terry Vanderkruyk
Director, Investor Relations, Protox Therapeutics Inc.
Tel: 604-688-4376
Cell: 604-789-0844
Fax: 604-688-0173
tvanderkruyk@protoxtherapeutics.com
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