Pall technology featured at FDA advisory meeting
East Hills, NY (February 8, 2005) - - Assessing the risk of potential exposure to variant Creutzfeldt-Jakob Disease (vCJD), the human form of 'mad cow disease,' from blood transfusion was the focus of the Food & Drug Administration (FDA) Transmissible Spongiform Encephalopathies (TSEs) Advisory Committee in Silver Spring, Maryland today. In response to the Committee's encouragement that new technologies should be considered that might lead to greater reduction of risk while not deferring many donors unnecessarily, Pall Corporation (NYSE: PLL) presented the latest scientific data on its new prion reduction technology. The Leukotrap® Affinity Prion Reduction Filter, expected to be launched commercially in Europe this spring, removes infectious prions from red cells, the most widely transfused blood component. Prions are associated with causing vCJD and other fatal neurodegenerative diseases, known as TSEs.
Sam Coker PhD, Principal Scientist and Technical Director of Pall Medical, acknowledged the public health community's heightened concern about the possibility of a second wave of mad cow disease in humans of unknown magnitude globally, including North America. Japan is the latest nation to confirm a human case of mad cow disease.
The unknown time interval between exposure to the infected prion and onset of symptoms exacerbates the challenge of determining the size of a second wave or epidemic. This asymptomatic characteristic poses the key question: How many dormant carriers of vCJD are out there who are at risk of developing clinical disease and who also may be blood donors?
There is currently a ban on blood donations from people who lived in countries with bovine spongiform encephalopathy (BSE) infected cattle, which can have an impact on availability and result in shortages of lifesaving blood components. A loss of one percent of donors involves approximately 75,000 to 85,000 individuals in the first year, not to mention their future potential donations. Leukocyte (white blood cell) reduction, which has been adopted by several nations to help decrease the risk of vCJD transfusion-transmission, removes only about 42 percent of TSE infectivity of blood.
The Pall Leukotrap Affinity Prion Reduction Filter was developed in response to these problems as part of the Company's mission to help ensure safety of the blood supply. It can remove leukocytes and all types of prions -- both cell and non cell-associated -- from blood prior to transfusion in a single step. Dr. Coker presented an overview of the key study results that show that the novel technology concurrently reduces leukocytes and prions with a 99 percent reduction of the infectious agent. He concluded that the new filter could be used to remove different strains of infectious prions, including those that cause vCJD.
He reviewed a study where it was found that the new filter reduces the human form of vCJD prions from red cells below the limit of detection of the Western blot assay, the gold standard of prion detection. He also discussed a study with the infectious scrapie prion that causes disease in sheep, which showed that the new filter removed all the infectious prions below the limit of detection of the Western blot assay.
Dr. Coker described in detail an animal infectivity study comparing filtered and unfiltered blood infected with scrapie prion. After the 300-day study, three of the 18 control hamsters that received the unfiltered blood developed scrapie. Only two of these animals had displayed clinical signs of the disease. None of the hamsters receiving filtered blood developed scrapie.
Dr. Coker also described the results of studies demonstrating that the filter does not damage red cells thereby not impacting their efficacy, purity and therapeutic value.
Pall Corporation expects to introduce the Leukotrap Affinity Prion Reduction Filter commercially in Europe this spring followed by submission to regulatory agencies in both Canada and the United States. The Company is also working on applying the basic technology to a diagnostic device to aid in the detection of (BSE) in cattle before entering the food supply.
About Pall Corporation
Pall Corporation is the global 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, pharmaceutical, transfusion medicine, semiconductors, water purification, aerospace and broad industrial markets. Total revenues are $1.8 billion. The Company headquarters are in East Hills, New York with extensive operations throughout the world. Visit Pall at www.pall.com.
Forward Looking Statement
This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act 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 the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at www.sec.gov.
Management uses certain non-GAAP measurements to assess Pall's current and future financial performance. The non-GAAP measurements do not replace the presentation of Pall's GAAP financial results. These measurements provide supplemental information to assist management in analyzing Pall's financial position and results of operations. Pall has chosen to provide this information to facilitate meaningful comparisons of past, present and future operating results and as a means to emphasize the results of ongoing operations.
Dr. Coker's FDA TSE Advisory Committee presentation along with photos and additional information on prions and The Leukotrap Affinity Prion Reduction Filter can be found at www.pall.com/corporate_45354.asp Interviews with Pall scientists and executives are available upon request.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
Published on PsychCentral.com. All rights reserved.
Problems are not stop signs, they are guidelines.
~ Robert Schuller