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From: TSS ()
Subject: Pall Prion Removal Technology Presented to FDA Blood Products Advisory Committee
Date: March 17, 2005 at 11:59 am PST

-------- Original Message --------
Subject: Pall Prion Removal Technology Presented to FDA Blood Products Advisory Committee
Date: Thu, 17 Mar 2005 10:18:04 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@KALIV.UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

La technologie d'ablation du prion de Pall Corporation soumise à
l'examen du Comité consultatif sur les produits sanguins de la FDA
CPN - 17/03/05 15:39

Presse économique / Santé / Médical
EAST HILLS, New York -- (BUSINESS WIRE) -- March 17, 2005 -- Le Comité
consultatif de la FDA sur les produits sanguins a placé au coeur des
discussions la mise à jourdes données actuellement connues concernant
les encéphalopathies spongiformes transmissibles (EST), dont le variant
de la maladie de Creutzfeldt-Jakob (vMCJ), la forme humaine de la
maladie de la « vache folle », lors de sa réunion qui s'est tenue ce
jour à Gaithersburg, dans le Maryland.
(BW)(NY-PALL)(PLL) Pall Prion Removal Technology Presented to FDA Blood
Products Advisory Committee
Business Editors/Health/Medical Writers
EAST HILLS, N.Y.--(BUSINESS WIRE)--March 17, 2005--An update on
Transmissible Spongiform Encephalopathies (TSEs), including variant
Creutzfeldt-Jakob Disease (vCJD), the human form of "mad cow" disease,
was a key topic at the Food & Drug Administration's Blood Products
Advisory Committee meeting in Gaithersburg, Maryland today.
Issues such as the number of people that could be harboring vCJD as
carriers, the impact on the blood supply and new risk reduction measures
were addressed.
Pall Corporation (NYSE:PLL) presented an overview of the latest research
on its prion reduction technology as a new risk reduction measure to
help prevent transfusion transmission of infectious prions that can
cause vCJD.
The Company expects to launch the new filter commercially in Europe this
spring. TSEs, also called prion diseases, are fatal neurodegenerative
diseases that include vCJD in humans; bovine spongiform encephalopathy
(BSE) in cattle; chronic wasting disease (CWD) in deer, elk and moose;
and scrapie in sheep.
These diseases are believed to be caused by prions, which are misfolded,
or "rogue", infectious proteins.
"So much remains unknown about prion diseases even as new information
comes to light practically daily.
No one really knows how many people may be harboring vCJD without
clinical symptoms and could potentially transmit the infection via blood
transfusion," according to Joseph Cervia, MD, a leading infectious
disease expert and medical director of Pall Corporation. He outlined the
myriad questions and uncertainties surrounding vCJD and other prion
diseases.
These include the length of the incubation period from time of exposure
to the onset of symptoms; the number of people potentially harboring
vCJD who are asymptomatic; the relationship to other neurodegenerative
diseases including Alzheimer's Disease; and whether other prion
diseases, such as CWD found in elk and deer across the U.S., can also
cross the species barrier to humans, as is the case with BSE in cows.
"We do, however, know for certain that vCJD is a devastating, invariably
fatal disease and that everything possible should be done to prevent its
spread and ensure the safety of the blood supply," he stated.
"Removing prions from blood prior to transfusion is an approach that can
lead to a greater reduction of risk and also mitigate the issue of blood
availability due to donor deferrals."
The Pall Leukotrap(R) Affinity Prion Reduction Filter simultaneously
reduces leukocytes (white blood cells) and all types of prions from red
blood cells in a single step.
Red cells are the most widely transfused blood component.
Leukoreduction of blood is approximately 40 percent effective in
reducing risk of vCJD infection, but is not sufficient since prions can
be both cell-associated (in leukocytes) and non-cell associated.
Dr. Cervia described the results of studies that show the novel
technology concurrently reduces both leukocytes and prions (cell and
non- cell associated) from red cell concentrates with a 99 percent
reduction of the infectious agent.
The research, conducted with vCJD and scrapie prions, showed that the
new filter removed the infectious prions to below the limit of detection
of the Western blot assay.
Dr. Cervia also described the results of studies demonstrating that the
filter does not damage red cells thereby not impacting their efficacy,
purity and therapeutic value.
Dr. Cervia emphasized the need to balance the efficacy of current
measures to prevent the transmission of vCJD via blood transfusion --
specifically donor deferral -- against the safety and availability of
life-saving blood components.
A loss of one percent of donors involves approximately 75,000 to 85,000
individuals in just the first year with a reverberating impact on blood
availability.
Currently, several nations, including the U.S. and Canada, defer blood
donors who have stayed in some countries where BSE has been found.
Japan, which recently confirmed its first vCJD patient, expanded its ban
on blood donations to anyone who stayed in Great Britain or France for
one day or longer between 1980 and 1996.
According to the Japanese Red Cross Society, this ban would cut
potential blood donors by several hundred thousand people per year and
may have a serious impact on the blood supply.
"We can no longer afford to view vCJD as a disease that is limited to a
few countries but must seriously consider new and better approaches to
prevent this devastating problem from escalating here," added Dr. Cervia.
"Combined filtration of leukocytes and prions is a cost efficient
approach to mitigate potential exposure and it can be easily integrated
with current blood handling logistics and good manufacturing practices."
Following CE mark and commercialization of the filter in Europe, Pall
Corporation plans to discuss this technology with regulatory agencies in
Canada and the U.S.
The Company is also studying the new filter as a 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,
semiconductor, water purification, aerospace and broad industrial markets.
Total revenues for fiscal 2004 were $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 inenforcing 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.
Editor's Note: Interviews with Dr. Cervia and other experts are
available upon request.
Photos and additional information on prions, the technology and research
studies can be found on http://www.pall.com/corporate_35914.asp.
CONTACT: Pall Corporation
Patricia Iannucci, 516-801-9100
Email: piannucci@pall.com
KEYWORD: NEW YORK
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL MEDICAL DEVICES BIOTECHNOLOGY
ALTERNATIVE MEDICINE
SOURCE: Pall Corporation
© CompanynewsGroup


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TSS

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