Press Release Details

Cerus Continues European Phase 3 Trial of Platelet System After Independent Review of Safety and Efficacy Data

January, 27 2000
Cerus Corporation (Nasdaq: CERS) today announced that the European clinical trial of their pathogen inactivation system for platelets has clearance to continue to enroll patients following a routine review of safety and efficacy data from the trial by an independent review board. The system, designed to inactivate viruses, bacteria and other pathogens that may be present in platelet concentrates for transfusion, is also in a Phase 3 clinical trial in the United States and is the only pathogen inactivation system for platelets to enter human clinical trials.

The role of the independent Data and Safety Monitoring Board (DSMB), is to evaluate the safety and efficacy data from the ongoing trial to determine whether there are safety or efficacy issues that would warrant modification or early termination of the study. This committee, comprising transfusion medicine experts from the European Union and the United States, recently completed its second scheduled meeting, which was conducted to review the safety and efficacy data from the first 41 patients enrolled in the trial.

"We were very pleased that the DSMB concurred that the safety and efficacy data supports continuation of the trial," said Cerus Vice President of Medical Affairs Laurence Corash, M.D. "We are very near completion of enrollment in this trial and we look forward to reporting the data from the completed trial later this year."

The multi-center European study is designed to evaluate the therapeutic efficacy of platelets treated with the company's pathogen inactivation system to support patients who require platelet transfusion and to control clinical bleeding. The trial will include approximately 100 patients, who will receive either treated or untreated platelets for a specified period of time. The primary endpoint to be evaluated is the change in the patients' post-transfusion platelet counts.

Cerus Corporation is developing systems designed to enhance the safety of blood transfusions by inactivating pathogens in blood components (platelets, fresh frozen plasma (FFP) and red blood cells) used for transfusion and for source plasma used for fractionation into various plasma products. 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 four 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'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 has ongoing clinical trials of its S-59 technology in the field of stem cell transplantation to treat leukemia and other hematologic malignancies. 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 and is a leader in technologies related to blood and the circulatory system.

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 1998 Annual Report on Form 10-K.

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