Press Release Details

Cerus Initiates Transfusion In Phase 1b Clinical Trial Of Its Pathogen Inactivation System For Red Blood Cells

May, 11 1999
Cerus Corporation (Nasdaq: CERS) today announced that it has initiated transfusions in its second clinical trial of its proprietary system to inactivate viruses, bacteria and other pathogens in red blood cells intended for transfusion.

The study is designed to evaluate the safety, tolerability and viability of red blood cells treated with Cerus' proprietary S-303 pathogen inactivation system. The study is designed to include approximately 30 healthy subjects who will each receive up to four transfusions of small volumes of S-303-treated red blood cells.

Cerus also announced the results of a Phase 1a clinical trial of its red blood cell pathogen inactivation system. The randomized, controlled study was designed to evaluate the post-transfusion viability of red blood cells treated with the S-303 pathogen inactivation system and stored for 35 days. The study showed that the circulation of both S-303-treated and untreated red blood cells 24 hours after transfusion exceeded the established standard for red blood cell recovery.

“The completion of our first clinical trial of our red blood cell system marks another important milestone for Cerus. As we move ahead with our Phase 1b trial, we remain the only company to bring a red blood cell pathogen inactivation system into the clinic,” stated Laurence Corash. M.D., Vice President for Medical Affairs at Cerus.

“I am very pleased with the progress we are making in our red blood cell program, which represents the third pathogen inactivation system for transfusion blood products we have in human clinical trials,” said Cerus President and Chief Executive Officer Stephen Isaacs. “We are committed to developing pathogen inactivation systems for the three primary transfusion blood products--platelets, fresh frozen plasma (FFP) and red blood cells--as well as an up-front method to treat source plasma prior to fractionation. We are very active in all four of these programs at Cerus.”

The Cerus red blood cell pathogen inactivation system has been developed to target and inactivate blood-borne pathogens while leaving the therapeutic properties of red blood cells intact. An estimated 31 million units of red blood cells are transfused worldwide each year in surgical settings and to treat various indications ranging from severe trauma to genetic disorders.

The company's pathogen inactivation systems for platelets, FFP and source plasma are based on Cerus' proprietary light-activated compound, S-59. 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 FFP system is currently in a Phase 2b patient study. 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 source plasma 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 1998 Annual Report on Form 10-K.

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