Press Release Details

Cerus Receives FDA Clearance to Proceed With Clinical Trials Of Its System For Allogeneic Bone Marrow Transplantation

February, 23 1999

CONCORD, Calif., Feb. 23 /PRNewswire/ -- Cerus Corporation (Nasdaq: CERS) announced today that the Food and Drug Administration (FDA) has reviewed the company's Investigational New Drug (IND) application for its allogeneic cellular immune therapy (ACIT) system and has concurred that the company may proceed with human clinical trials. The company's ACIT system is being developed to improve transplant engraftment and reduce serious adverse immune responses relating to bone marrow transplantation procedures.

Bone marrow transplantation is a highly effective treatment for many forms of leukemia and other cancers. Bone marrow transplantation is most effective when the donor is very closely matched to the patient for the major human leukocyte antigen (HLA) groups. As part of the bone marrow transplantation procedure, patients receive donor T-cells. While these T-cells improve engraftment of the bone marrow transplant and help reconstitute the patient's immune system following chemotherapy or radiation therapy, donor T-cells expose the patient to a high risk of contracting graft-versus-host-disease (GVHD). GVHD, which has a high mortality rate, is caused by the proliferation of donor T-cells which attack the patient's healthy tissue. The company's ACIT system has been developed to decrease the stringency of matching donors to patients and to inhibit the ability of donor T-cells to cause GVHD while maintaining their therapeutic properties.

"Our preclinical studies in mice have shown that our ACIT system to treat donor T-cells reduced mortality due to GVHD and improved engraftment," said Cerus vice president of new science opportunities John Hearst, Ph.D. "Based on these results, we are eager to move into human clinical trials and are pleased that the FDA has given us the green light to proceed."

The Cerus ACIT program is based on the company's proprietary light-activated psoralen compound, S-59. This compound has been developed to target and prevent the replication of DNA and RNA, which are required for cellular replication.

Cerus Corporation is also collaborating with the Fenwal Division of Baxter Healthcare Corporation to develop, manufacture and market pathogen inactivation systems for blood components (platelets, plasma and red blood cells) intended for transfusion. Programs for each of the three components are currently in clinical trials. 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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