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Protox Therapeutics achieves manufacturing milestone towards an IND Filing

Tuesday, January 11, 2005 - Vancouver, British Columbia - Protox Therapeutics Inc. ("Protox" or "the Company") announced today that it has achieved a critical milestone in its preparations for the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). The IND application relates to initiation of Phase I clinical trials of its lead product, PSA-PAH1, for the treatment of localized prostate cancer. The Company has transferred its manufacturing process for PSA-PAH1 to the Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison and WCBF has quickly and successfully produced the necessary clinical batches of the drug candidate under current Good Manufacturing Practice (cGMP) conditions.

"Completion of this important manufacturing milestone is a key requirement of the FDA and it takes us one step closer to the filing of our first IND. This achievement, and the positive results we are continuing to see in our expanded pre-clinical trials, give us comfort that we will be able to achieve our goal of filing an IND for PSA-PAH1 by mid-2005," said Tazdin Esmail, President and CEO of Protox. "Protox has succeeded at the manufacturing phase where many early stage biotech companies fail. This success demonstrates that the manufacturing process developed by Dr. Tom Buckley, our Chief Scientific Officer and his scientific group, can be both reproduced and scaled up by a third party under cGMP conditions."

"We have been impressed with the functional process transferred to us by Dr. Buckley and Protox," said Derek Hei, Technical Director at the WCBF. "His process has allowed us to make large quantities of clinical grade PSA-PAH1 under cGMP conditions in a highly efficient manner".

PSA-PAH1 was created for the treatment of prostate cancer by engineering the naturally occurring protein Aerolysin. The Company plans to use its Aerolysin technology platform to develop additional therapeutic products for the treatment of other types of cancer.

About the Waisman Clinical BioManufacturing Facility: WCBF is a state-of-the-art facility for the production of experimental human biotherapeutics in compliance with cGMP requirements. Located at the University of Wisconsin-Madison's Waisman Center, the WCBF also provides services to UW-Madison investigators and their external collaborators in advancing cutting-edge experimental therapeutics from basic research to testing in human clinic trials. For more information, visit their website www.gmpbiomanufacturing.org.

About Protox: Protox Therapeutics Inc. is developing novel, cancer therapeutics based on modified proteins engineered from the naturally occurring bacterial toxin, Aerolysin. These modified Aerolysin proteins have demonstrated the ability to selectively target and kill cancer cells while leaving healthy "bystander" cells and tissues intact. The Company believes that its targeted approach may produce 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

What's New

November 13, 2008
Protox Reports 2008 Third Quarter Results

November 5, 2008
Protox Announces Amendments To Certain Outstanding Warrants

October 8, 2008
Protox Announces Positive 12 Month Data From BPH Study

September 30, 2008
Protox Appoints Dr. Jack Geltosky to its Board of Directors

Events

Bio-Europe 2008
When:
November 17-19
Where: Mannheim, Germany

 

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