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Protox reports efficacy data of prostate cancer drug in animals

Wednesday, April 20th, 2005 - Vancouver, British Columbia - Protox Therapeutics Inc. announces completion of a set of animal studies that provide further evidence of the efficacy of its lead product, which is being developed for the treatment of localized prostate cancer. The product is a genetically engineered form of the naturally occurring protein Aerolysin, which kills cells by forming holes in them.

The studies were conducted at Johns Hopkins Kimmel Cancer Center under the direction of Sam Denmeade, M.D., and will be presented on Wednesday, April 20 at the 96th Meeting of the American Association of Cancer Research (AACR) held in Anaheim, California. Simon Williams, Ph.D., who was awarded the AARC-AFLAC Scholar in Training Award for this research, will present the paper entitled Tumoricidal effects of a PSA-activated pore forming toxin. Protox' Chief Scientific Officer, Tom Buckley, Ph.D., is a co-author of the paper. A brief summary of the results are as follows:

  • Preliminary studies with cell lines confirmed that engineered proaerolysin preferentially killed prostate cancer cells.
  • An in vivo study showed that a series of intratumoural injections of engineered proaerolysin into human prostate tumours growing in mice resulted in large reduction in tumour volume and the mice showed no signs of toxicity.
  • Decrease in prostate specific antigen (PSA) levels is one of the key markers now used to determine response of prostate cancer to therapy. The effect of intratumoural injection on blood PSA levels was studied in human prostate tumour-bearing mice by injecting microgram doses of engineered protein into the tumours every 72 hours. The results showed complete cessation of tumour growth and a substantial decrease in blood PSA levels.

These studies establish for the first time the potential to use a modified pore-forming toxin for prostate cancer therapy. They demonstrate the efficacy of the Company's lead product with cell lines and human prostate tumours growing in mice, and provide considerable preclinical support for its use in the treatment of localized prostate cancer.

"We are very pleased with the pace of the company's pre-clinical development program", said Dr. Fahar Merchant, President and CEO of Protox. He adds, "These data validate the strength of our platform technology. The results are particularly satisfying when taken together with the safety data we are getting from our pilot and GLP animal studies."

Protox expects to file an Investigational New Drug Application (IND) application with the United States Food and Drug Administration (FDA) this summer for its first product designed for the treatment of localized prostate cancer. Subject to FDA approval, the Company intends to proceed with Phase I clinical trials.

A copy of the abstract can be obtained by visiting the Protox website www.protoxtherapeutics.com under the Publications section.

ABOUT PROTOX: Protox Therapeutics Inc. is developing novel cancer therapeutics by engineering the naturally occurring bacterial toxin Aerolysin, which kills cells by forming pores in them. The Company believes that its engineering approach will produce targeted cancer therapeutics that have greater efficacy and fewer side effects than existing cancer treatments.

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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