PALO ALTO, Calif. and PORTON DOWN, England -- Genencor International, Inc. and the United Kingdom's Health Protection Agency, Business Division (HPA) announced today that its two-year collaboration to develop a commercially viable technology to eradicate infectious prions is in advanced stages and results to date are very encouraging. The process developed by HPA, formerly the Centre for Applied Microbiology & Research (CAMR), uses a proprietary thermostable Genencor protease enzyme to destroy infectious prions that are now widely seen as the causative agent of Bovine Spongiform Encephalopathy (BSE) and its human form, variant Creutzfelt-Jakob Disease (CJD).
Several patents have recently been filed in the United States, Europe, Canada, Japan and Australia with claims describing the inactivation and detection of transmissible spongiform encephalopathy (TSE) agents. The partners are preparing a data package, including ongoing bioassay studies, for discussion with regulatory authorities in the European Union. Once the remaining long-term experiments have been completed, the partners will seek regulatory guidance for the application of the process in decontaminating surgical instruments.
In the United Kingdom (UK), surgical instruments used in procedures involving patients suspected of CJD are disposed of rather than sterilized and re-used in order to minimize the risk of exposure to other surgical patients. The new process is expected to offer a safe and cost effective alternative.
"While the long-term experiments are still ongoing, the preliminary results strongly suggest the efficacy of our process to substantially reduce the risk of infectivity by prions," said Neil Raven, PhD, prion research director at HPA, Porton Down. "Based on these encouraging results, we are now reasonably confident that our process will enable a new solution to prion elimination."
The partners expect the final decontamination study results within 12 to 18 months. The study employs an in-vivo model that is widely recognized as a standard assay. While waiting for the results, commercial discussions will continue with potential partners. A dialogue will begin soon with the UK Department of Health to identify the optimum way to validate this process for surgical instrument decontamination.
The technical collaboration with the Health Protection Agency has been very successful," said Tom Pekich, group vice president of bioproducts for Genencor. "We want to be properly positioned with regulators and with potential commercial collaborators to bring this technology to the market as soon as possible."
Genencor International is a diversified biotechnology company that develops and delivers innovative products and services into the healthcare, agri-processing, industrial and consumer markets.
The Health Protection Agency is a new national organization for England and Wales, established April 1, 2003. It is dedicated to protecting people's health and reducing the impact of infectious diseases, chemical hazards, poisons and radiation hazards. It brings together the expertise of health and scientific professionals working in public health, communicable disease, emergency planning, infection control, laboratories, poisons, chemical, and radiation hazards. The expert group in new infectious diseases is the former Centre for Applied Microbiology & Research (CAMR) now a part of the HPA Business Division based at Porton Down.
Source: Genencor International