Cerus Moves Forward With U.S. Phase III Platelet Pathogen Inactivation Trial Following Monitoring Board Report; Company Cleared to Complete 600 Patient Pivotal Trial.Business Editors/Health & Medical Writers CONCORD, Calif.--(BW HealthWire)--December 5, 2000 Cerus Corporation (Nasdaq:CERS) today announced that it has received final clearance from an independent Data and Safety Monitoring Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ) to complete enrollment in its ongoing U.S. 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 Platelet System. The system, designed to inactivate in·ac·ti·vate v. 1. To render nonfunctional. 2. To make quiescent. in·ac  ti·va viruses, bacteria and other pathogens in platelets intended for transfusion, is being jointly developed by Cerus and Baxter Healthcare Corporation. The review by the DSMB is intended to provide independent evaluation or identification of potential safety or efficacy issues that might warrant protocol modification or early termination of ongoing trials. Based on a review of data that included the first 300 patients to complete all transfusions in the Phase III trial, the DSMB determined that the data supported continuation of the trial as planned, with no need for additional DSMB reviews. "This final DSMB review is a significant milestone in our pivotal U.S. Phase III Intercept Platelet System clinical trial," said Laurence Corash, M.D., vice president of Medical Affairs at Cerus. "We look forward to completing the trial, which we believe will support a regulatory submission to the U.S. Food and Drug Administration." In collaboration with Baxter, Cerus is conducting the multicenter 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 trial. The trial is designed to evaluate the safety and efficacy of transfusing Intercept platelets compared to platelets prepared without 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. . Recently, the company reported favorable results from a European Phase III trial of the Intercept Platelet System. Cerus and Baxter are preparing a CE Mark Application for the system, seeking registration in Europe. About Cerus Cerus Corporation is developing medical systems and therapeutics based on the company's proprietary Helinx technology for targeting 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. and 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 to control biological replication. 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 completed a European Phase III clinical trial of the Intercept Platelet System and is conducting further clinical trials of the Intercept Blood Systems in the United States: a Phase III 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 . About Baxter 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 in 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 red blood cell: see blood. System are trademarks of Baxter International, Inc. Statements in this news release regarding product development, clinical development, regulatory activity 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 uncertainty of the timing and results of any clinical trials, action by regulatory authorities, the uncertainty of market acceptance of any products, competitive conditions, the uncertainty of future financing and other factors discussed in the companies' 1999 Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and Cerus' Prospectus dated November 1, 2000. |
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