Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare Corporation today announced that they have received United States Food and Drug Administration concurrence to proceed with their second pivotal Phase III trial for the INTERCEPT Red Blood Cell System. This trial will evaluate INTERCEPT red blood cell use for chronic transfusion support (transfusions occurring over an extended period of time), and will run simultaneously with the companies' Phase III trial for acute transfusion support, which is already underway. The INTERCEPT Red Blood Cell System is a pathogen inactivation system being developed to protect against transmission of infectious diseases through red blood cell transfusions.
“With both of our Phase III red blood cell trials proceeding, we continue to move toward commercialization,” said Stephen T. Isaacs, president and chief executive officer of Cerus. “We plan to enter the marketplace with the INTERCEPT Red Blood Cell System after launches of INTERCEPT Blood Systems for platelets and plasma.”
The multicenter, double-blind, randomized Phase III trial is expected to enroll approximately 50 patients who require red blood cell transfusion support for the treatment of chronic anemia due to hereditary disorders such as sickle cell disease or thalassemia. In this crossover trial, each patient will receive, in random order, red blood cells treated with the INTERCEPT process and control red blood cells which are not prepared with a pathogen inactivation process. The primary endpoint of the trial is a comparison of the amount of INTERCEPT red blood cells and control red blood cells transfused to manage the patients' chronic anemia.
The chronic Phase III trial is the second of two pivotal trials the companies intend to conduct for the INTERCEPT Red Blood Cell System. The first trial, which is currently underway, is a 200 patient trial comparing the use of INTERCEPT red blood cells to control red blood cells in an acute transfusion support setting. Data from the two trials are expected to support both European CE Mark and U.S. PMA registration applications.
Red blood cells are disc-shaped cells containing hemoglobin, which delivers 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 trauma and during surgery, or to increase hemoglobin levels in patients with chronic 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. Separately, the companies are preparing the U.S. regulatory submission 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™ 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 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: 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 in more than 100 countries.
Helinx is a trademark of Cerus Corporation
INTERCEPT is a trademark of Baxter International, Inc.
Statements in this news release regarding clinical trials, regulatory filings, product development and commercial 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, manufacturing, 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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