Press Release Details

Cerus and Baxter Begin Enrollment in U.S. Phase 3 Trial of System to Improve the Safety of Platelet Transfusions

July, 22 1999
Cerus Corporation (Nasdaq: CERS) and its development and marketing partner, Baxter Healthcare Corporation, today announced that they have initiated enrollment of patients in a Phase 3 clinical trial of a system developed to inactivate viruses, bacteria and other pathogens that may be present in platelet concentrates for transfusion. The system, which is also in a Phase 3 clinical trial in Europe, is the first pathogen inactivation system for platelets to enter human clinical trials.

The multi-center study is designed to evaluate the ability of platelets treated with the company's pathogen inactivation system to control clinical bleeding. The U.S. Phase 3 trial will include approximately 600 patients, who will receive either treated or untreated platelets for a specified period of time. The primary endpoint to be evaluated is the incidence of clinical bleeding events while the patients are receiving platelet support.

“We are very pleased with the potential of our systems to enhance the safety of the blood supply,” said Cerus President and Chief Executive Officer Stephen Isaacs. “Our systems represent a fundamentally different approach to transfusion safety in that they inactivate a broad range of viruses, bacteria and other pathogens in blood, rather than merely test for the most serious known viral pathogens.”

The Cerus platelet system is based on the company's proprietary light-activated psoralen compound, S-59. This compound has been developed to target and inactivate blood-borne pathogens, such as hepatitis B and C, while leaving the therapeutic properties of platelets intact. An estimated 3.5 million units of platelets are transfused annually worldwide to prevent bleeding in a broad range of patients, including those undergoing cancer therapy and surgical procedures.

Cerus is also developing pathogen inactivation systems for fresh frozen plasma (FFP) and for red blood cells. The FFP system, also based on the S-59 compound, has been cleared to proceed into a Phase 3 patient study. The red blood cell system, based on the company's proprietary pH-activated anchor-linker-effector (ALE) compound, S-303, is in a Phase 1b clinical trial in healthy subjects.

Cerus Corporation is developing systems designed to enhance the safety of blood transfusions by inactivating pathogens in blood components (platelets, FFP and red blood cells used for transfusion) and by inactivating white blood cells, which are responsible for a variety of adverse transfusion reactions. Cerus is also collaborating with the Consortium for Plasma Science to develop a system to treat source plasma used for fractionation into various plasma products. The company's platform technologies, which prevent viral, bacterial and cellular replication, have potential applications in the health care field beyond pathogen inactivation in blood components.

Cerus Corporation is collaborating with the Fenwal Division of Baxter Healthcare Corporation to develop, manufacture and market pathogen inactivation systems for blood components used for transfusion. Baxter, a global medical products and services company, focuses on critical therapies for life-threatening conditions. Baxter is a leader in technologies related to blood and the circulatory system. The Fenwal Division develops, manufactures and markets products and services for the collection, separation, storage and transfusion of blood and its components.

Statements in this news release regarding product development and clinical development 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, regulation by the FDA, the uncertainty of replication of animal data in humans, the uncertainty of market acceptance of any products, competitive conditions, the uncertainty of future financing and other factors discussed in the company's 1997 Annual Report on Form 10-K.

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