BioManufacturing Facility in Wisconsin TSX-V:PRX VANCOUVER, Oct. 7 /CNW/ - Protox Therapeutics Incorporated ("Protox") today announced that it has entered into a manufacturing agreement with the Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison to manufacture clinical batches of PSA-PA1, its lead product in development for the treatment of localized prostate cancer. Production of PSA-PA1 under Good Manufacturing Practice (cGMP) conditions will be a requirement when the Company files an Investigational New Drug (IND) application with the United States FDA by mid-2005 to initiate Phase I Human trials. "Protox is planning to file an Investigational New Drug application with the FDA for PSA-PA1, our lead product in development as soon as possible in order to proceed with Phase I Human Trials. We are keen to move forward with our planned progressive research to demonstrate, both in further pre-clinical trials and in later human trials, the unique potential of our technology in treating localized prostate cancer," said Dr. Tom Buckley, Chief Scientific Officer of Protox. "WCBF appears to be most suited to produce our lead product in development within our budget and timelines. This contract work, along with our recently announced CTBR agreement to conduct expanded pre-clinical trials (August 17, 2004) are key major milestones which will keep our aggressive development plans on track." "This is a very exciting project for our facility and we are confident in our ability to produce PSA-PA1 in a timely and cost effective manner," said Derek Hei, Technical Director at the WCBF, (formerly Director of Biomedical Engineering at Cerus Corp.). We are very impressed with the scalable manufacturing process that the Protox scientists have developed for the production of PSA-PA1." ABOUT THE WAISMAN CLINICAL BIOMANUFACTURING FACILITY: The Waisman Clinical BioManufacturing Facility (WCBF) is a state-of-the-art facility that is equipped with experienced staff and specialized equipment that are necessary for producing experimental human biotherapeutics in compliance with the FDA (cGMP) requirements. The WCBF is designed to manufacture clinical-grade biological pharmaceuticals for early stage (Phase I and Phase II) human clinical trials. 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. has developed, and has licensed from third parties, technologies intended to transform the naturally occurring bacterial toxin, Aerolysin, into novel, cancer therapeutics. Once altered using Protox' proprietary technology, Aerolysin has demonstrated the ability to target and kill cancer cells by forming holes in their membranes while leaving healthy 'bystander' cells intact. The Company anticipates that this approach will produce therapeutics that may have greater efficacy and lower side effects than current methods of treating cancer. The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this News Release. This News Release contains forward-looking statements about Protox's future drug research and development plans, which statements can be identified by the use of forward-looking terminology such as "planned", "to proceed", "move forward", "to demonstrate", "potential", "to produce", "development", "designed to", or the negative thereof or any other variations thereon or comparable terminology referring to future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and Protox's actual results could differ materially from those anticipated in those forward-looking statements as a result of numerous factors, including without limitation, uncertainty as to whether Protox's products will be further developed and marketed successfully as a drug or at all; the fact that results from preclinical studies may not be predictive of results obtained in clinical trials; the need for regulatory approvals prior to undertaking clinical trials and prior to marketing a final product, which approvals may not be obtained on acceptable terms or at all; uncertainty as to whether Protox will file an IND by mid-2005 or at all; the fact that Protox is currently negotiating licenses from third parties necessary to market its product, which licenses may not be obtained upon acceptable terms or at all, including a license of the technology on which its product PSA-P1A is based; the fact that Protox will be required to undertake additional pre-clinical studies before it will be able to proceed to clinical trials and there can be no assurance regarding the timing or outcome of such studies, whether the results of such studies will enable the Protox to proceed with clinical trials, or as to the timing or outcome of any clinical trials; general research and development risks; the risk of technical obsolescence; product liability risks; insurance risks; manufacturing risks and the need to manufacture to regulatory standards; the effect of competition; the risk of adverse side effects; intellectual property risks; the need for additional capital, the availability of which is not assured; changes in business strategy or development plans; the dependency of Protox on key personnel; uncertainty as to future market size and market acceptance of Protox's products; and partnership/strategic alliance risks; as well as a description of other risks and uncertainties affecting Protox and its business, as contained in news releases and filings with regulatory authorities, any of which could cause actual results to vary materially from current results or Protox's anticipated future results. Forward-looking statements are based on the beliefs, opinions and expectations of Protox's management at the time they are made, and Protox does not assume any obligation to update its forward-looking statement if those beliefs, opinions or expectations, or other circumstances should change. /For further information: regarding Protox, contact: Terry Vanderkruyk, Director, Investor Relations, Protox Therapeutics Inc., Tel: (604) 688-4376, Cell: (604) 789-0844, Fax: (604) 688-0173, tvanderkruyk(at)protoxtherapeutics.com/ (PRX.) CO: Protox Therapeutics Inc. ST: British Columbia IN: MTC SU: CON -30-
Protox Therapeutics signs manufacturing agreement with Waisman
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