Press Release Details

Cerus Sets Preliminary Parameters For U.S. Phase 3 Platelet Trial

January, 26 1999
Cerus Corporation (Nasdaq: CERS) today announced that, in consultation with the U.S. Food and Drug Administration (FDA), it has determined the preliminary framework governing the company's Phase 3 clinical trial protocol for its platelet pathogen inactivation system. This determination triggers a commitment by the company's development and marketing partner, Baxter Healthcare Corporation, to purchase $2 million of Cerus common stock at 120% of the market price. Cerus is the first company to complete a U.S. Phase 2 clinical trial of a pathogen inactivation system for platelets, and is the first to have commenced a Phase 3 trial for platelets in Europe.

Based on recent discussions with the FDA, Cerus believes that the multiple site trial will be a randomized, controlled study designed to evaluate the ability of platelets treated with the company's pathogen inactivation system to control clinical bleeding. While the details of the final protocol are not complete, the Company believes 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 clinical bleeding events while the patients are receiving platelet support.

“We are very pleased with our progress toward commencement of a U.S. Phase 3 trial and with Baxter's commitment to make the milestone payment,” said Cerus President and Chief Executive Officer Stephen Isaacs. “Now that we have determined the principal parameters of the trial, our focus turns to finalizing the details of the protocol and preparing to initiate the study as soon as possible. Our goal is to introduce a pathogen inactivation system that can significantly reduce the risk of viral and bacterial transmission through platelet transfusions.”

“We are pleased to have reached consensus on a readily measurable hemostatic endpoint,” said Cerus vice president of medical affairs Laurence Corash, M.D. “Though the size is larger than trials we have previously conducted, we believe our experience in managing our multiple site Phase 3 trial for platelets in Europe and our ability to draw upon Baxter's expertise will be very valuable resources in conducting this trial.”

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.

The company also is developing pathogen inactivation systems for fresh frozen plasma (FFP) and for red blood cells. The FFP system also is based on the same S-59 compound, and the company has received clearance to proceed into a Phase 2b patient study. The red blood cell system, based on its proprietary pH-activated anchor-linker-effector (ALE) compound, S-303, is in a Phase 1a 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, plasma and red blood cells used for transfusion) and by inactivating white blood cells, which are responsible for a variety of adverse transfusion reactions. The company's platform technologies, which prevent viral, bacterial and cellular replication, may 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 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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