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.gmpbio.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.