Novel Technology That Reduces Infectious Prions `Mad Cow Disease' from Blood Unveiled at International Transfusion Meeting.EAST HILLS, N.Y. -- Pall Provides Prion prion (prī`ŏn), infectious agent thought to cause a group of diseases known as
prion diseases or transmissible spongiform encephalopathies. Research Update in Preparation for European Availability
Pall Corporation (NYSE NYSE
See: New York Stock Exchange : PLL PLL - phase-locked loop ) unveiled an innovative, proprietary technology that reduces prions from blood prior to a transfusion at the annual meeting of the International Society for Blood Transfusion (ISBT ISBT International Society of Blood Transfusion
ISBT International Society of Beverage Technologists
ISBT Integrated Science, Business, and Technology
ISBT Interstate Bus Terminus (Delhi)
ISBT International School of Bowen Therapy ) in Edinburgh, Scotland today. The soon to be released Leukotrap(R) Affinity Prion Reduction Filter will provide the dual benefit of reducing harmful white blood cells White blood cells
A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system.
Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies while also reducing infectious prions, the rogue proteins that cause variant Creutzfeldt-Jakob Disease (vCJD). The Company presented the latest animal model research results in anticipation of launching the new filter in Europe in early 2005, where the problem of vCJD, the human form of bovine spongiform encephalopathy bovine spongiform encephalopathy: see prion. (BSE See Bombay Stock Exchange.
See Boston Stock Exchange (BSE). ) or mad cow disease mad cow disease: see prion.
mad cow disease
or bovine spongiform encephalopathy (BSE)
Fatal neurodegenerative disease of cattle. Symptoms include behavioral changes (e.g. , is most critical.
The Pall prion reduction technology will provide a multi-targeted approach to blood safety by reducing leukocytes and infectious prions that are either cell associated or non-cell associated. In blood, about 60 percent of prion infectivity resides in leukocytes (cell-associated) and about 40 percent in plasma (non-cell associated). Research results show that the new filter has an affinity to all types of prions, including aggregated, denatured de·na·ture
tr.v. de·na·tured, de·na·tur·ing, de·na·tures
1. To change the nature or natural qualities of.
2. and normal.
"This is a major milestone in the quest to protect the public from this insidious and always fatal neurodegenerative disease," said Eric Krasnoff, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Pall Corporation. "We are moving this technology forward rapidly. This is a seminal event in the international effort to stop the spread of vCJD. Blood centers and hospitals will soon be able to combine both prion and leukocyte reduction in a single, simple step."
The specter of prion transmission from human-to-human via a blood transfusion came to the forefront in December 2003 when a case of vCJD was identified in a person who received a blood transfusion six years earlier from a donor who later died of the disease. Since vCJD has an unknown, albeit lengthy, incubation period that is asymptomatic, there is no way to know how many people already have the disease and how many could have already transmitted it via blood transfusion.
Prion Removal Research Results
With support from the New York Institute of Basic Research, Pall Corporation is studying the new filter using three different assays -- Western blot assay, bioassay Bioassay
A method for the quantitation of the effects on a biological system by its exposure to a substance, as well as the quantitation of the concentration of a substance by some observable effect on a biological system. and animal models of prion disease -- to validate reduction of infectious prions.
An endogenous infectivity study evaluated the efficacy of a prototype filter for the removal of scrapie-infected prions from red blood cell red blood cell: see blood. concentrates. After a 300-day incubation period, none of the hamsters (20) that received the filtered red cells developed scrapie scrapie: see prion. , a transmissible spongiform encephalopathy Transmissible spongiform encephalopathies (TSEs, also known as prion diseases) are a group of progressive conditions that affect the brain and nervous system of humans and animals and are transmitted by prions. . During the same period, two out of the 18 hamsters that received unfiltered red cells developed scrapie, exhibiting the clinical signs and symptoms of the disease.
It was found that the prototype Pall prion removal filter removed infectious prions from red cell concentrates below the limit of detection of the Western blot assay, the gold standard used to determine the presence of prions. A bioassay was also used to quantify the amount of prion removal. It was found that the filter removed approximately 4 logs of scrapie-infected prions. The evidence to date, as demonstrated in the animal model, suggests the reduction of prions, both free and leukocyte leukocyte (l`kəsīt'): see blood.
or white blood cell or white corpuscle bound, may provide a higher margin of transfusion safety.
Mr. Graham Rowe, head of Laboratory Services of the Welsh Blood Service, also reported at ISBT the results of a study he conducted to determine what, if any, effects the new filter may have on red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.
Mentioned in: Bone Marrow Transplantation
red blood cells following the usual storage periods and procedures. This study evaluated the filter using three commonly used but different anticoagulants Anticoagulants
Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms.
Mentioned in: Embolism, Heart Valve Replacement and their associated storage times. He compared the effects of prion and leukocyte filtered red cells to leukocyte only filtered red cells, and also compared these results to historical data. These preliminary results have demonstrated that blood filtered with the Pall Leukotrap Affinity prion reduction filter is substantially equivalent to control blood units from a safety and efficacy point of view.
Since a majority of blood transfused in the industrialized in·dus·tri·al·ize
v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es
1. To develop industry in (a country or society, for example).
2. world is currently leukocyte reduced, a filtration approach can swiftly and easily fit into routine operating (cGMP) practice already in use in blood centers around the world.
It is expected that the new technology will meet the requirements of the Council of Europe Council of Europe, international organization founded in 1949 to promote greater unity within Europe and to safeguard its political and cultural heritage by promoting human rights and democracy. The council is headquartered in Strasbourg, France. for a CE mark and will be ready for operational trial in Europe beginning in early 2005. The Company continues to study the new technology and will release additional results on the animal model research in the coming months. The Company is also planning to conduct clinical surveillance studies after receiving the CE mark to continue to advance knowledge about transmission of prion diseases.
A Boon to Public Health and Safety
Although the incidence of new cases of vCJD have appeared to slow down over the past few years, many experts believe we should not be lulled into a false sense of security. Since the disease has an unknown incubation period without clinical sign or symptoms, a proportion of the population could be harboring vCJD and acting as blood donors. The existence of sub-clinical prion carriers raises concerns of a human-to-human wave of transmission, posing a potential threat to the safety of the blood supply. These experts contend that the possibility of further increases in the number of cases, even a human epidemic of vCJD, cannot be dismissed. Since the risk of vCJD is not restricted to the UK, the examination of the history of blood donation may be required in other European countries and elsewhere.
Pall is also studying the new technology as a potential detection device to identify mad cow disease in cattle, as a means to help protect the food supply. According to an April 2004 Consensus Conference on TSEs, there is currently no reliable or practical way available to determine the presence of BSE and vCJD in food or in living asymptomatic animals or people.
Prion diseases are fatal, neurodegenerative diseases, referred to as Transmissible Spongiform Encephalopathies (TSEs) that affect both humans and animals. They include scrapie in sheep, bovine spongiform encephalopathy in cattle and variant CJD CJD
CJD Creutzfeldt-Jakob disease, see there in humans. It is estimated that the incubation period (prior to clinical symptoms) for variant CJD may be anywhere between 10 to 20 years. Since the first human case of vCJD was identified in 1994, there have been 154 confirmed cases worldwide with the vast majority (143) in the United Kingdom. On December 17, 2003, the Secretary of Health of the United Kingdom announced the first case of a patient dying from variant CJD received from a blood transfusion during an operation.
About Pall Corporation:
Pall Corporation is the leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, municipal drinking water, aerospace and broad industrial markets. Total revenues are $1.6 billion. The Company headquarters are in East Hills, New York East Hills is a village in Nassau County, New York on the North Shore of Long Island. It is considered part of the Greater Roslyn area, which is anchored by the Village of Roslyn. As of the United States 2000 Census, the village population was 6,842. with operations in more than 30 countries. Further information is available at www.pall.com.
This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements are based on current Company expectations and are subject to risks and uncertainties which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at www.pall.com and is included in the Company's reports filed with U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at: www.sec.gov.
Photos of the Leukotrap Affinity Prion Reduction Filter, video and abstracts of studies are available at www.pall.com/pressroom.
Interviews with Pall researchers and executives are available at Edinburgh International Conference Center (Cromdale Hall--Pall Stand # 26) and/or by calling Patricia Iannucci at 516-801-9100.
Samuel Coker, PhD, Technical Director and Principal Scientist, R&D, Pall Corp. gave an oral presentation on the research results "Removal of Infectious Prion from Naturally Infected Red Blood Cell Concentrates" on July 13, 2004 at the Balmoral Hotel, The Sir Walter Scott Suite, One Princes Street, Edinburgh, Scotland.