News Releases

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