News ReleasesPrinter friendly version
Protox files IND for the treatment of prostate cancer
Wednesday, December 14, 2005 - Vancouver, British Columbia - Protox Therapeutics
Inc. announced today that it has submitted an investigational new drug (IND)
application to the U.S. Food and Drug Administration (FDA) for the Company’s
lead product, PRX302. Protox plans to initiate Phase 1 clinical trials of
PRX302, for the treatment of recurrent localized prostate cancer, early next
year upon approval of the IND by the FDA.
“Filing our first IND with the FDA is the most important milestone for
2005 and brings us closer to fulfilling the unmet needs resulting from a cancer
that afflicts more than 230,000 North American men every year,” stated
Dr. Fahar Merchant, President and CEO of Protox. “This accomplishment
reflects our Company’s capability and commitment to advance PRX302 for
not only prostate cancer but also BPH (benign prostatic hyperplasia), and
ultimately to commercialize the PORxin™ platform for these and other
cancers.”
“At present there are no licensed drugs available for salvage therapy
of purely local recurrence of prostate cancer,” continued Dr. Merchant.
“PRX302 is a novel, first-in-class pore-forming prodrug that is activated
by prostate specific antigen (PSA), an enzyme that is produced by, and only
active in, the prostate. We believe that the combined use of image-guided
local delivery and a pro-toxin targeted for PSA-producing cells may allow
us to effectively treat localized prostate cancer without the side effects
usually associated with current treatments.”
The Phase I trial will be an open-label, dose-escalation clinical trial of
PRX302 in patients with locally recurrent prostate cancer and enrollment of
patients is planned to begin immediately after IND activation by the FDA.
Phase I trials 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 18-24 patients and has been designed to determine safety,
tolerability and therapeutic activity of PRX302. The company plans to file
an IND for PRX302B for the treatment of BPH in 2006.
About Prostate Cancer
Prostate cancer is one of the most common malignancies in American men. It
is estimated that nearly 232,090 men in the United States will be diagnosed
with prostate cancer in 2005. In most men with prostate cancer, the disease
grows very slowly and is initially found to be localized and confined to the
gland. Nearly 30,250 men will die of prostate cancer in 2005. PRX302 is being
developed for the treatment of localized recurrent prostate cancer in men
with locally progressing disease without evidence of metastases. The intended
route of administration for PRX302 in humans is by intra-prostatic injection.
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. To improve
the outcomes for patients with localized prostate cancer, adjuvant hormonal
therapy or chemotherapy may also be used.
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
| 
