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 red blood cell pathogen inactivation system and has concurred that the company may proceed with human clinical trials. Cerus is the first company to reach this stage of development of a pathogen inactivation system for red blood cells. This milestone triggers a $3 million investment in Cerus common stock at 120% of market price by its development and marketing partner, Baxter Healthcare Corporation. Cerus will use the proceeds to fund development of its pathogen inactivation systems for platelets, plasma and red blood cells.
"This is the first pathogen inactivation system for red blood cells to be cleared to proceed into human clinical trials, and reaching this milestone is a major achievement for our scientific staff," said Cerus President and Chief Executive Officer Stephen Isaacs. "Red blood cells represent a tremendous opportunity as they are by far the most commonly transfused blood product. This system is a great complement to our platelet and plasma pathogen inactivation systems which are currently in clinical development."
The Cerus red blood cell system is based on its proprietary pH-activated anchor-linker-effector (ALE) compound, S-303. This compound 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.
In a separate press release, Cerus announced today it has commenced a European Phase 3 study of its pathogen inactivation system for platelets. The platelet system is also in a Phase 2c patient study in the United States. The company's pathogen inactivation system for plasma intended for transfusion is currently in a U.S. Phase 2 clinical study in healthy subjects.
Cerus Corporation is developing systems designed to enhance the safety of blood transfusions by inactivating infectious 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 technology, which prevents viral, bacterial and cellular replication, has additional 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.
This news release contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements, particularly those regarding product approvals, commercialization and markets, as a result of certain factors, including the uncertainty of the timing and results of any trials, regulation by the FDA, modifications of the agreements with Baxter, 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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