Cerus and Baxter Report Positive Phase III Results for the INTERCEPT Platelet System; Data Support Therapeutic Effectiveness of INTERCEPT Platelets.Business Editors/Medical Writers CONCORD, Calif. & DEERFIELD, Ill.--(BUSINESS WIRE)--Aug. 17, 2001 Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation today reported that the primary endpoint has been successfully met in their U.S. 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 of the INTERCEPT Platelet System. The results support the effectiveness of INTERCEPT platelets to treat and prevent bleeding during severe thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. , a medical condition characterized by a persistent reduction in platelet levels. The companies are jointly developing the INTERCEPT Platelet System, 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. system being developed to protect against transmission of infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. and occurrence of transfusion reactions, which may result from blood transfusions. "We are very excited about these results which were collected from a broad and thorough clinical experience," said Stephen T. Isaacs, president and chief executive officer of Cerus. "These data show that our INTERCEPT Platelet System maintains the therapeutic performance of platelets which have undergone pathogen inactivation using our proprietary technology. We look forward to completing our modular PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy submission to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. seeking U.S. marketing approval of the product." The 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. , controlled, double blind 671-patient clinical trial was designed to evaluate the therapeutic efficacy and safety of INTERCEPT platelets. In the trial, platelet transfusions were administered to reduce the risk of bleeding during severe thrombocytopenia and to treat active bleeding. The primary endpoint of the study was a comparison of the proportion of patients with moderate bleeding (Grade 2 World Health Organization criteria) following platelet transfusion with either INTERCEPT platelets or platelets that had not been treated with a pathogen inactivation process. The data showed that the proportion of patients with moderate bleeding between the patients who received INTERCEPT platelets and control groups was statistically equivalent and within 1% of each other, solidly achieving the trial's goal of a less than 12.5% difference between the two groups. The study also evaluated a number of secondary endpoints comparing INTERCEPT platelets to untreated platelets, including those intended to detect differences in numbers in numbered parts; as, a book published in numbers. See also: Number of platelets transfused and increases in platelet counts post-transfusion. These data, some of which showed statistically significant differences, will provide physicians with additional information on INTERCEPT platelets. Data on secondary endpoints are undergoing further analysis. The companies will submit the data from this study for presentation at a forthcoming scientific meeting. More than four million platelet transfusions are performed annually in Western Europe Western Europe The countries of western Europe, especially those that are allied with the United States and Canada in the North Atlantic Treaty Organization (established 1949 and usually known as NATO). , North America and Japan to prevent bleeding in a variety of patients, including those undergoing cancer therapy and surgical procedures. While donated platelets are generally tested for a limited number of specific pathogens, testing does not eliminate the risk of viral contamination, and there are no routine tests to screen for bacteria. Bacterial contamination in collected platelets is of particular concern as bacteria quickly multiply in nutrient-rich platelet concentrates, which are stored at room temperature. Also, white blood cells White blood cells A 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 platelet transfusions can potentially result in graft-vs-host disease and other severe immune reactions in the transfusion recipient. The INTERCEPT Platelet System is being developed to target the nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. of viruses, bacteria, other pathogens and white blood cells to improve the safety of platelet transfusions. In a separate release today, the companies announced results from the Phase IIIb trial of the INTERCEPT Plasma System, which demonstrated that the primary endpoint of that study also was successfully met. Cerus and Baxter also are conducting a Phase IIIc trial for the INTERCEPT Plasma System and are preparing to begin a Phase III trial with their INTERCEPT Red Blood Cell red blood cell: see blood. System. 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 the blood products used for transfusion. These 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. The Concord, California-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. Statements in this news release regarding 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 reports on Forms 10K, 10Q and other filings with the Securities and Exchange Commission. More detailed information on the results of the Phase III trial of the INTERCEPT Platelet System are contained in a report on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. , being filed with the Securities and Exchange Commission by Cerus concurrently with this news release. 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. |
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