Blood Safety Innovations Announced by Pall At American Association of Blood Banks Annual Meeting; A New Era in Blood Safety Rapidly Approaches.

Business Editors, Health/Medical Writers

WASHINGTON--(BW HealthWire)--Nov. 3, 2000

Blood transfusion leaders reviewed the latest developments on new technologies designed to improve blood transfusion safety at the symposium Leading Edge Technologies--Advancing Blood Safety Worldwide, at the American Association of Blood Banks (AABB) annual meeting.

Panelists spoke on state-of-the-art blood safety measures from the rapid adoption of universal leukocyte (white blood cell) filtration around the globe to the newest developments in detection of bacterial contamination of platelets and revolutionary pathogen inactivation technology to prevent transfusion transmission of viruses, bacteria and protozoa. "We are at the center of a medical revolution in blood safety," said Eric Krasnoff, Chairman and CEO of Pall Corporation (NYSE:PLL), which hosted the meeting. "We are proud to be on the leading edge of developments that will help bring an improved standard of care to everyone who needs a blood transfusion."

Paul M. Ness, MD, President of AABB and Director of Transfusion Medicine at Johns Hopkins Medical Institutions and President of AABB, noted that the shift to this new generation of blood components is challenging the transfusion medicine specialists' ability to provide the highest quality care, especially in a financially constrained health care environment.

"The role of the transfusion medicine specialist must change from gatekeeper to an aggressive patient advocate for improved patient care," he stated. "Unlike medical conditions, such as AIDS and hemophilia, which have a strong physician and patient advocacy to ensure that the latest innovations are made available to all patients, transfusion recipients do not have an obvious champion." Dr. Ness added, "We must fulfill our primary medical responsibility of providing the best and safest transfusion care for our patients without being eclipsed by cost reimbursement or legal issues."

"Mark Brecher, MD, Professor of Pathology and Laboratory Medicine at the University of North Carolina (UNC) and Director of Transplantation and Transfusion Service at McLendon Laboratories UNC Hospitals, spoke on the need for new technology to combat bacterial contamination of blood products, the greatest infection threat in transfusion medicine today. The incidence of platelet bacterial contamination is about 1 in 2,000 units and severe morbidity or death may occur in as many as 150 cases per year in the U.S. This is a persistent but often overlooked problem because it is commonly under recognized and underreported.

The key concern, according to Dr. Brecher, is to identify a method with enough sensitivity to detect bacterial contamination of platelets in the shortest period of time. Unlike most viruses, which can be detected at the time of donation, bacteria frequently require time to proliferate during storage before they can be detected.

"If we could achieve a highly sensitive system that detects a majority of the organisms by day 3 storage, it might also enable us to extend the shelf life of platelets from 5 to 7 days," Dr. Brecher said. "By extending shelf life, we will be able to reduce the outdating of platelet inventories, use this limited medical resource more efficiently and save lives."

Jerry Ortolano, Ph.D., VP Scientific and Laboratory Services, Pall Corporation, affirmed Dr. Brecher's presentation in an overview of several new and innovative approaches Pall Corp. is undertaking to detect bacterial contamination of transfused platelets. Diagnostic systems are being developed using O2 levels in the test sample as a surrogate marker for the presence of bacteria. The systems use a specially designed filter that reduces white blood cells and platelets but allows plasma and bacteria to be transmitted into a sample pouch. The closed system device is able to detect whether or not the platelets are contaminated. One of the systems being developed measures the O2 change in the headspace (airspace) of the sample pouch to indicate the presence of bacteria.

Another system stemming from this technology platform also under development uses the fundamental principle of reduction oxidation (redox) combined with microelectronics. As the O2 rate of change exceeds a predetermined threshold, a microchip sends a signal illuminating a red light on the device indicating the presence of bacteria establishing that these platelets should not be transfused. Conversely, if the O2 rate of change remains below the predetermined threshold, the microchip sends a signal illuminating a green light confirming that the platelets are suitable for transfusion.

Dr. Ortolano concluded by stating, "We believe this approach will result in highly sensitive, rapid detection of bacterial contamination of platelets in a closed processing device that can be easily integrated into hospital blood banking systems."

INACTINE(TM) Pathogen Inactivation Technology, a revolutionary technology with the potential to safeguard the blood supply from bacterial and viral contaminants including known viruses, such as HIV and hepatitis C, and emerging pathogens was the focus of the presentation by John Chapman, Ph.D., VP, Blood Products Research, V.I. Technologies, Inc. (VITEX) (Nasdaq: VITX). INACTINE(TM) Pathogen Inactivation Technology, the result of a collaborative effort between VITEX and Pall Corporation, recently received approval to commence a Phase II clinical trial. The study is a randomized, controlled, parallel-group evaluation of the safety and maximum storage time of a unit of INACTINE(TM) technology treated red blood cells when administered to normal adult subjects. The storage time is determined by the in vivo survival of the unit of INACTINE(TM) technology treated red blood cells relative to a control red blood cell unit. The novel INACTINE(TM) Pathogen Inactivation Compound is designed to inactivate viruses, bacteria and protozoa by disrupting the replication of the nucleic acid without diminishing the therapeutic value of red cells.

Dr. Chapman presented the results of studies that investigated the survival of red blood cells treated with INACTINE(TM) Pathogen Inactivation Compound. The in vitro data showed the INACTINE(TM) Compound's ability to inactivate a broad spectrum of viruses (enveloped and non-enveloped) and bacteria that account for a majority of transfusion associated infections.

"In preclinical in vitro laboratory tests with red blood cells, the INACTINE(TM) Compound has been shown to have an inactivation effect on a broad spectrum of pathogens while preserving the quality and oxygen-carrying function of the red blood cells. Further, animal studies have shown that the INACTINE(TM) treated red cells are well tolerated," Dr. Chapman said. Phase I clinical trial results in humans will be released in December at the American Society of Hematology meeting.

Graham Sher, MD, VP Medical, Scientific, Clinical Management for Canadian Blood Services reviewed Canada's experience as the first and only country in North America to mandate universal leukocyte reduction. Canada is one of ten nations around the world implementing routine blood filtration as a standard of care for all patients. He explained that donor white blood cells are responsible for a majority of transfusion reaction complications. Pall blood filters can reduce donor white blood cells from transfused blood, improve patient outcomes, shorten hospital stays and lower health care costs. Dr. Sher stated, "Universal leukocyte reduction is an important component of our commitment to provide Canadians with safe, secure and reliable blood components and blood products."

In concluding remarks, Barry Wenz, MD, Executive Medical Director at Pall Corp. and symposium moderator, stated, "Pall is moving full-speed ahead with these initiatives that have placed us on the forefront of blood safety from our leadership in blood filtration, and our ongoing efforts in bacterial detection and pathogen inactivation technology to ensure an even safer blood transfusion for all people around the world."

Editors Note: Pall is the acknowledged technology leader in the increasingly complex and demanding filtration industry and has been for more than 50 years. Pall serves customers throughout the health care and industrial marketplace. In addition to providing leading-edge products for transfusion medicine, Pall is a primary supplier to the biopharmaceuticals, semiconductor, and municipal drinking water industries, to name a few.

Pall blood filters are used in all ten countries that have mandated universal leukocyte reduction and in the 13 countries, including the US, that are moving toward routine blood filtration. In addition to co-developing INACTINE(TM) Pathogen Inactivation, Pall will be the exclusive marketer of the INACTINE(TM) product for both red cells and platelets. Pall is also involved in extensive research and development in many other areas of blood safety including devices designed for sensitive and early detection of bacterial contamination of platelets, considered to be one of the greatest transfusion risks today.

Pall (NYSE:PLL) has annual sales of over $1 billion. The Company is headquartered in East Hills, New York and has operations in over 30 countries. Further information can be found at http://www.pall.com.

Pall is the acknowledged technology leader in the increasingly complex and demanding filtration industry and has been for more than 50 years. The Company serves more markets with more proprietary products than any other company in the $31 billion filtration industry. With annual sales over $1 billion, Pall Corporation is based in East Hills, New York, USA and operates directly in 30 countries. The Company's shares are listed on the New York Stock Exchange (PLL). Further information is available on the Company's web site at http://www.pall.com.