CERUS/BAXTER APPLY FOR CE MARK FOR INTERCEPT PLATELET SYSTEM.Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation have submitted a CE Mark application for approval to market the Intercept Platelet System in Europe. The system, which is being jointly developed by Cerus and Baxter Healthcare Corporation, is designed to inactivate in·ac·ti·vate v. 1. To render nonfunctional. 2. To make quiescent. in·ac ti·va viruses, bacteria, other pathogens and white blood cells White blood cellsA 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 in platelets intended for transfusion. If approved, the Intercept Platelet System will be the only system commercially available to enhance the safety of platelet transfusions through pathogen inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent. . "This is a landmark achievement which was accomplished through a concerted effort between both Baxter and Cerus," said Stephen T. Isaacs, president and chief executive officer of Cerus. "We look forward to the approval of the Intercept Platelet System and working with Baxter to launch the first system to inactivate pathogens in platelets." Harry M. Jansen Kraemer, Jr., chairman and chief executive officer of Baxter said, "We are very pleased with the significant progress of the Cerus and Baxter teams. This is a very important step toward enhancing the safety of platelet transfusions in Europe." Approximately 1.3 million platelet transfusions are performed annually in Europe to prevent bleeding in a variety of patients, including those undergoing cancer therapy and surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. . While donated platelets are generally tested for a limited number of specific pathogens, testing does not eliminate the risk of viral contamination, and most tests are not designed to screen for bacteria. Bacterial contamination is of particular concern as bacteria quickly grow in nutrient-rich platelet concentrates, which are stored at room temperature. Also, white blood cells from donated platelets can potentially result in graft-vs-host disease and other severe immune reactions in the transfusion recipient. The Intercept Platelet System is designed to inactivate viruses, bacteria, other pathogens and white blood cells in donated platelets prior to transfusion. Cerus Corporation is developing medical systems and therapeutics based on the company's proprietary Helinx technology for inactivating disease-causing agents. Helinx is designed to target and lock DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. or RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic , and has the ability to prevent the replication of viruses, bacteria and other pathogens and to control cellular proliferation. The company's most advanced programs are focused on systems to enhance the safety of the world's blood supply. These Intercept Blood Systems, based on the Helinx technology, are designed to inactivate viruses, bacteria and other pathogens. The Concord, California-based biopharmaceutical company, in collaboration with its development and commercialization partner Baxter Healthcare Corporation, has submitted a CE Mark Application for marketing approval of the Intercept Platelet System in Europe. In addition, the company is conducting clinical trials of the Intercept Blood Systems in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. : a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial for platelets, a Phase III trial for plasma and a Phase Ic trial for 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 . Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International (NYSE NYSE See: New York Stock Exchange :BAX). Baxter International, through its subsidiaries, is a global medical products and services company that provides critical therapies for people with life-threatening conditions. The company's products and services in bioscience (biopharmaceuticals and blood collection, separation and storage devices), medication delivery and renal therapy are used by health-care providers and their patients more than 100 countries. For more information, call 925/288-6061. |
|
||||||||||||||

ti·va
Printer friendly
Cite/link
Email
Feedback
Reader Opinion