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Release issued 5th August 2003
Genencor International (Nasdaq: GCOR) and the UK's Centre for Applied Microbiology & Research (CAMR) announced today they have signed an exclusive collaboration to develop technology to detect and eliminate prions. Prions are thought to be the infectious agent that causes Bovine Spongiform Encephalopathy (BSE), also known as mad cow disease and its human form, variant Creutzfeld-Jakob Disease (CJD). The two-year collaboration is focused on an enzyme-based process for treating surgical equipment, rendered animal material and blood products to eliminate prion infectivity. The collaboration will also investigate developing an effective rapid detection test.
CAMR has discovered a process using a proprietary Genencor enzyme that reduces prion infectivity and shows promising results in bioassays. The process treats the infected material under relatively mild temperature and pH conditions. This work will be of potential value in relation to sterilization procedures in hospital practices and in decontaminating rendered animal material. The research was research funded by the UK's Department of Health and the Ministry of Agriculture, Fisheries and Food (MAFF) and the European Commission.
European Union governments are strictly controlling the disposal of animal remains over concerns that the prions could contaminate the environment. Currently, carcasses and rendered material are being stored in cold storage units and warehouses throughout Europe. There are over 600,000 tons of rendered contaminated cattle byproducts in the UK. Estimates are that by year-end, up to 3 million tons of potentially contaminated material could be stored in the European Union.
The collaboration combines Genencor's leading protease platform, targeting technology, assay development and protein engineering with CAMR's expertise in exotic infectious disease, biological containment, vaccine development and prion expertise. The program will build on preliminary work on a rapid detection technology carried out by CAMR. Genencor will provide CAMR with upfront funding, milestones and royalty payments as part of their collaboration to commercialize enzyme-based prion treatment technologies. Genencor will receive exclusive rights to commercialize any protease enzyme product resulting from the collaboration.
"CAMR is pleased to be collaborating with one of the world's leading biotechnology companies to address this critical health problem," said Roger Gilmour, PhD, CEO of CAMR. "The combined assets and special talents of our two organizations are well suited to solving the riddles of prions, a new and very tough transmissible agent." CAMR has tested its process with biochemical analysis and a bioassay. This is the first evidence that specifically designed proteases may have the ability to degrade the normally protease-resistant prions. An additional set of candidates from Genencor's proprietary protease collection is being investigated. Once a final candidate is chosen, Genencor will work to optimize the candidate for the specific applications.
"The results of our bioassays show encouraging positive data about the inactivation of prions," said Neil Raven, PhD, prion research program director, CAMR. "Our efforts will focus on further testing, using Genencor's specially designed proteases to find the optimal agent, as well as investigating the development of a reliable and sensitive diagnostic tool." The collaborators bring complementary skills to the investigation of a rapid diagnostic assay. Genencor has successful proprietary targeting technology. CAMR brings expertise in developing ELISA-based analytical methods and bioassay validation models.
"The emergence of prions as an unconventional infectious agent has caught the world by surprise. We are pleased that the protease technology franchise we've built over the past 19 years could contribute to solving this difficult problem," said W. Thomas Mitchell, chairman and CEO of Genencor. "With the skills and world class expertise that CAMR brings, we believe that real progress can be made."
"CAMR has made significant progress in understanding the basic science of prions," said Michael Arbige, PhD, senior vice president and chief technology officer, "we hope to leverage our i-biotech platform of protein engineering and molecular evolution and design expertise to help take their discoveries to the next level and ultimately, to the market."
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