Press Release Details

Cerus Initiates Phase 1 Allogeneic Bone Marrow Transplant Study

June, 30 1999
Cerus Corporation (Nasdaq: CERS) announced today that it has treated the first patient in a Phase 1 study of its allogeneic cellular immune therapy (ACIT) system. The company's ACIT system is being developed to improve engraftment of the donor bone marrow and to reduce the occurrence of serious adverse reactions to the procedures, including graft-versus-host-disease (GVHD).

The study is designed to enroll approximately 30 patients who will receive treated donor T-cells as an adjunct to haploidentical (half-matched) bone marrow transplants. The first patient received a transfusion of donor T-cells treated with the company's light-activated psoralen compound, S-59, in conjunction with bone marrow cells provided by a parent.

Bone marrow transplantation is a highly effective treatment for many forms of leukemia and other cancers, and is most effective when the donor is very closely matched to the patient for the major human leukocyte antigen (HLA) groups. As part of a bone marrow transplant procedure, a patient receives 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 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 inhibit the ability of donor T-cells to proliferate and cause GVHD while maintaining the therapeutic properties of these cells.

“We designed the study to gain more insight into the ability of donor T-cells, which have been modified by our procedure, to improve the outcomes of allogeneic bone marrow transplants,” said Cerus Vice President of New Science Opportunities John Hearst, Ph.D. “Based on our preclinical results, we hope to see successful engraftment of the donor bone marrow with a reduced incidence of the very severe adverse reactions patients often have to mismatched donor T-cells.”

“It is very exciting to see the application of Cerus' S-59 technology in a therapeutic setting,” said Cerus President and Chief Executive Officer Stephen Isaacs. “Many of the patients waiting to find a matched donor have a living parent, sibling or child who could serve as a haploidentical donor if the adverse reactions to these procedures were less severe.”

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 developing proprietary systems to improve the safety of blood products through the inactivation of viruses, bacteria and other pathogens. Programs for platelets, plasma and red blood cells intended for transfusion are currently in clinical trials. Cerus is also developing a system as an up-front method to treat source plasma used for fractionation into various plasma products. Cerus has collaboration agreements with Baxter Healthcare and the Consortium for Plasma Science.

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 1997 Annual Report on Form 10-K.

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