VANCOUVER, Oct. 24, 2006 (Canada NewsWire via COMTEX) -- First patient treated with PRX302 at prestigious cancer center
Protox(TM) Therapeutics Inc. (TSX-V:PRX) today announced that the University of Texas M. D. Anderson Cancer Center, following Institutional Review Board (IRB) approval, has initiated treatment of its first patient in the Company's ongoing Phase I clinical trial using PRX302 for localized recurrent prostate cancer. M. D. Anderson joins the University of Vermont and Scott & White Memorial Hospital, lead center in the trial, which began treating patients in May 2006.
"The addition of a world-renowned center like M. D. Anderson further confirms our commitment to realizing the full potential that we believe this therapeutic approach will provide for men suffering from prostate cancer," said Dr. Fahar Merchant, President and Chief Executive Officer of Protox Therapeutics. "We look forward to reporting interim results later this year."
PRX302 is a pro-drug activated by prostate specific antigen (PSA), an enzyme produced in high levels by prostate cancer cells. Once activated, PRX302 reduces the size of a tumor by destroying cancer cells by creating a hole or pore in the cell membrane. PRX302 is expected to have fewer side effects than traditional or current systemic treatments because it is delivered locally to the prostate.
The Phase I trial is intended to examine the safety, tolerability and therapeutic activity of PRX302 in patients with localized recurrent prostate cancer. PRX302 is injected into the prostate under sonographic guidance. Each new cohort of patients receives a higher dose of PRX302 once safety of the drug is established in the previous cohort. Changes in PSA levels are measured and prostate biopsies are performed after 30 days to monitor therapeutic activity. The Company expects to report interim data from the trial before the end of 2006.
About M. D. Anderson Cancer Center,
The University of Texas M. D. Anderson Cancer Center, has established an international reputation as one of the world's preeminent centers for cancer patient care, research, education and prevention. M. D. Anderson was designated by the National Cancer Institute (NCI) as one of the first three Comprehensive Cancer Centers in the United States. Named the nation's top cancer hospital by U.S. News and World Report's four out of the past six years, more than 70,000 cancer patients receive care at M. D. Anderson each year.
About Prostate Cancer
Prostate cancer is one of the most common malignancies in North American men. One in every six men is diagnosed with prostate cancer during their lifetime. It is estimated that during 2006 approximately 250,000 new cases of prostate cancer will be diagnosed and some 30,000 men will die from the disease throughout North America. Current treatment options for localized prostate cancer include surgery (radical prostatectomy), brachytherapy (implantation of radioactive seeds), and external beam irradiation. Serious side effects are associated with all these therapies including erectile dysfunction, incontinence and bowel problems.
Protox Therapeutics is a product-focused clinical-stage company and a leader in advancing novel, targeted protein toxin therapeutics for treatment of cancer and other proliferative diseases. The company is actively developing two distinct but complementary platforms, INxin(TM) and PORxin(TM), and currently has three clinical programs in development. A Phase IIa clinical trial into the use of 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. In addition, a Phase I trial has been completed for PRX321 to treat patients with renal cell carcinoma and non-small cell lung cancer. Patient enrolment is underway for a Phase I clinical study into the use of PRX302 (PORxin) to treat localized prostate cancer. A second Phase I clinical trial will commence early next year for PRX302 to treat benign prostatic hyperplasia.
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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.
SOURCE: Protox Therapeutics Inc.
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