Press Release Details

Cerus Receives FDA Clearance to Proceed with Phase 3 Study of Its Fresh Frozen Plasma Pathogen Inactivation System

May, 12 1999

CONCORD, Calif., May 12 /PRNewswire/ -- Cerus Corporation (Nasdaq: CERS) today announced that, in consultation with the U.S. Food and Drug Administration (FDA), it has received clearance to proceed with a Phase 3 clinical trial of its proprietary system to inactivate viruses, bacteria and other pathogens in fresh frozen plasma (FFP). The Cerus FFP pathogen inactivation system is based on the company's proprietary light-activated compound, S-59.

The single-arm, open-label study is designed to evaluate coagulation factor function following transfusion of FFP treated with the company's pathogen inactivation system. Approximately 30 patients will be enrolled in the study, and will receive FFP for treatment of certain types of congenital clotting factor deficiencies. Cerus also intends to conduct Phase 3 clinical trials in patients receiving FFP to treat acquired clotting factor deficiencies and in patients requiring large volume FFP exchange to treat diseases such as thrombotic thrombocytopenic purpura.

"We are pleased with the rapid progress we have made in this program over the past year," said Cerus President and Chief Executive Officer Stephen Isaacs. "This milestone is not only the result of the leadership and hard work of our FFP team, but also of the groundwork laid by our experience in the platelet program, which is based on similar technology and the same proprietary compound, S-59."

"The system is very complementary to our pathogen inactivation system for platelets," said Cerus Vice President of Medical Affairs Laurence Corash, M.D. "We developed our FFP pathogen inactivation system as a single unit process which can be performed in the local blood centers without the introduction of risks associated with the pooling of thousands of units of plasma."

The Cerus pathogen inactivation system has been developed to target and inactivate blood-borne pathogens while leaving the therapeutic properties of FFP intact. An estimated 10 million units of FFP worldwide are transfused annually in surgical settings and to prevent bleeding for a broad range of congenital and acquired deficiencies of clotting proteins.

The company also is developing pathogen inactivation systems for platelets, red blood cells and source plasma for fractionation. The platelet system is currently in a European Phase 3 clinical study and the company is finalizing a protocol for a Phase 3 study in the U.S. The red blood cell system, based on the company's proprietary pH-activated compound, S-303, is in Phase 1 clinical trials. The source plasma system is in preclinical development.

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 safety 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 1998 Annual Report on Form 10-K.

CONTACT: Stephen Isaacs, President and CEO, or Greg W. Schafer, CFO, both

of Cerus Corporation, 925-603-9071; or Ana Kapor, Investors, or

Amy Flood, Media, both of Noonan-Russo Communications, Inc.,

415-677-4455, for Cerus Corporation

 

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