Cerus and Baxter Initiate Clinical Site in Pivotal Phase III Trial for Intercept Red Blood Cell System.Business Editors/Health & Medical Writers CONCORD, Calif.--(BW HealthWire)--Jan. 9, 2002 Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation today announced they have initiated the first clinical trial site for their pivotal Phase III clinical trial Noun 1. phase III clinical trial - 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 of the INTERCEPT Red Blood Cell red blood cell: see blood. System and have received Institutional Review Board (IRB IRB See: Industrial Revenue Bond ) approvals at two other clinical trial sites. Last quarter, the companies received U.S. Food and Drug Administration concurrence CONCURRENCE, French law. The equality of rights, or privilege which several persons-have over the same thing; as, for example, the right which two judgment creditors, Whose judgments were rendered at the same time, have to be paid out of the proceeds of real estate bound by them. Dict. de Jur. h.t. on this acute protocol, and with IRB approvals now in place, the first transfusions are expected to begin shortly. The INTERCEPT Red Blood Cell System is being developed to protect against transmission of infectious diseases infectious diseases: see communicable diseases. through red blood cell transfusions. "Initiating the first clinical trial site for this Phase III trial is a significant milestone and clearly demonstrates our leadership in addressing the substantial red blood cell market," said Stephen T. Isaacs, president and chief executive officer of Cerus. "We maintain a unique position in the industry with the INTERCEPT Blood Systems, the only technology in late-stage development for all three blood components: platelets, plasma and 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 ." The multi-center, double-blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Phase III protocol is expected to enroll approximately 200 patients requiring acute red blood cell support as a result of cardiac surgery. The primary endpoint of the trial is a comparison of the clinical performance of INTERCEPT red blood cells to control red blood cells, which are not prepared with a 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. process. The acute Phase III protocol is one of two pivotal trials the company intends to conduct for the INTERCEPT Red Blood Cell System. The second trial, which is expected to be initiated shortly, will be a 50 patient trial to compare the use of INTERCEPT red blood cells to control red blood cells in support of patients with chronic anemia due to hereditary disorders such as sickle cell disease sickle cell disease or sickle cell anemia, inherited disorder of the blood in which the oxygen-carrying hemoglobin pigment in erythrocytes (red blood cells) is abnormal. or thalassemia Thalassemia Definition Thalassemia describes a group of inherited disorders characterized by reduced or absent amounts of hemoglobin, the oxygen-carrying protein inside the red blood cells. . Red blood cells are disc-shaped cells containing hemoglobin, which enables the cells to deliver oxygen from the lungs to the rest of the body. Red blood cells are the most frequently transfused blood component, with an estimated 30 million units being transfused each year in North America, Europe and Japan. Patients typically receive red blood cell transfusions to offset blood loss after severe accidents and during surgery, or to increase hemoglobin levels in patients with anemia. Cerus and Baxter are collaborating on the development of INTERCEPT Blood Systems to enhance the safety of blood transfusions. In addition to the INTERCEPT Red Blood Cell System, Cerus and Baxter are developing pathogen inactivation systems for platelets and plasma. A CE Mark application seeking European approval for the INTERCEPT Platelet System has been submitted and the companies have begun the regulatory submission process in the United States. The companies are preparing to begin the U.S. regulatory submission process for the INTERCEPT Plasma System, which will be followed by a CE Mark application for this product. About Cerus Cerus Corporation is developing medical systems and therapeutics based on its proprietary Helinx(TM) technology for controlling biological replication. Cerus' most advanced programs are focused on systems to enhance the safety of blood products used for transfusion. The INTERCEPT Blood Systems, based on the company's Helinx technology, are 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 . The Concord, Calif.-based company also is pursuing therapeutic applications of Helinx technology to treat and prevent serious diseases. About Baxter Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE NYSE See: New York Stock Exchange :BAX). Baxter is a global medical products and services company that, through its subsidiaries, provides critical therapies for people with life-threatening conditions. The company's products and services in bioscience (biopharmaceuticals, vaccines, biosurgery and transfusion therapies), medication delivery and renal therapy are used by health-care providers and their patients more than 100 countries. Note to Editors: Helinx is a trademark of Cerus Corporation INTERCEPT Blood System, INTERCEPT Platelet System, INTERCEPT Plasma System and INTERCEPT Red Blood Cell System are trademarks of Baxter International Inc. Statements in this news release regarding clinical trials, regulatory filings, product development and product potential are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risks and uncertainty of the timing and results of clinical trials and other development activities, actions by regulatory authorities at any stage of the development process, additional financing activities, market acceptance of any products, competitive conditions and other factors discussed in the companies' most recent filings with the Securities and Exchange Commission. |
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