Cerus and Baxter Report Positive Results in Trial of INTERCEPT Red Blood Cells; Companies Prepare for Phase III Clinical Trials.Business Editors/Health & Medical Writers SAN ANTONIO--(BW HealthWire)--Oct. 17, 2001 Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation (NYSE NYSE See: New York Stock Exchange :BAX) today announced preliminary results from the Phase Ic clinical trial of their INTERCEPT Red Blood Cell red blood cell: see blood. 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 diseases infectious diseases: see communicable diseases. through red blood cell transfusions. The results showed that INTERCEPT 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 were well tolerated and demonstrated comparable recovery and survival performance to red blood cells which had not been treated with the pathogen inactivation process. The data were presented by Jorge Rios Jorge Paes Rios was born in Rio de Janeiro, Brazil, on April, 1945. He is an hydraulics and sanitary engineer and professor. He is a Brazilian researcher and Professor at the Federal University of Rio de Janeiro. He is also a scientific leader. He lives in Rio de Janeiro. , M.D., assistant medical director, American Red Cross American Red Cross: see Red Cross. , New England New England, name applied to the region comprising six states of the NE United States—Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, and Connecticut. The region is thought to have been so named by Capt. Region at the American Association American Association refers to one of the following professional baseball leagues:
"We are pleased with the preliminary results from this trial, which mark the completion of a very thorough Phase I clinical program for the INTERCEPT Red Blood Cell System," said Stephen T. Isaacs, president and chief executive officer of Cerus. "Based on these results and discussions with the U.S. Food and Drug Administration, we are moving directly to Phase III trials of this product, which we expect to begin shortly." The two-part Phase Ic trial included 40 individuals, 29 of whom participated in a study designed to evaluate the performance of INTERCEPT red blood cells compared to untreated red blood cells. Preliminary results from this study showed that mean survival of INTERCEPT red blood cells following infusion was 62.2 days, which did not show statistical difference from the 61.1 days of survival of untreated red blood cells. In addition, the two groups showed comparable mean recovery, with 79.4 percent of INTERCEPT red blood cells surviving 24 hours after infusion compared to 84.7 percent in the untreated group. The remaining 11 individuals participated in a study to evaluate the tolerability of full transfusions of INTERCEPT red blood cells. The data showed that INTERCEPT red blood cells were well tolerated with no serious adverse events observed. Cerus and Baxter are collaborating on the development of the INTERCEPT Blood Systems to enhance the safety of blood transfusions. The companies are seeking U.S. and European approval of the INTERCEPT Platelet System and are conducting a 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 Plasma 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, utilizing 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, 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: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. 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion