By Jim Shrine

Circe Biomedical Inc. bought out of its subsidiary relationship with W.R. Grace & Co. and raised $16.4 million privately as it continues development of its liver support system.

Management of the Lexington, Mass., company gained full control through a buyout arrangement with Grace, a specialty chemicals company in Boca Raton, Fla., that has divested most of its health-care related interests over the past few years.

The $16.4 million financing is expected to take Circe through an ongoing Phase II/III pivotal trial of the HepatAssist Liver Support System and into early commercialization, Circe President Barry Solomon said. Solomon and other senior managers were involved in the project when Circe first was a part of the Grace research group and then a wholly owned subsidiary.

¿Management at Grace got to the point they were not interested in continuing funding of the business,¿ Solomon said. ¿They supported a deal that allows them to get their return later down the line but they no longer have a financial obligation to fund the project.¿ Grace doesn¿t have an equity position, either, he said.

The financing included investments from Polaris Venture Partners, of Waltham, Mass; Bessemer Venture Partners, of Wellesley, Mass.; Advanced Technology Ventures, of Waltham; Spray Venture Partners and BancBoston Ventures Inc., both of Boston; and Mayo Medical Ventures, of Rochester, Minn.

¿We believe we are the most medically advanced [in this area] as far as where we are in clinical trials,¿ Solomon said. ¿We have a product we believe is commercially viable.¿

Nearly 100 percent of the focus at Circe is on the HepatAssist System, which consists of a hollow fiber bioreactor and normal porcine liver cells. They are combined in a system designed to provide temporary liver function to those with liver failure or awaiting a transplant.

A key part of the system, Solomon said, is commercial-scale cryopreservation technology for the cells, so they can be stored at medical centers indefinitely and be available for immediate use.

The system is being tested on patients who have rapid onset of liver failure due to causes such as poisoning or viral hepatitis, and those awaiting emergency liver transplantation.

¿Our system really is a temporary treatment to provide time to the patients for their own liver to regenerate or until the liver is available for transplantation,¿ Solomon said.

The Phase II/III trial is being carried out at 14 centers in the U.S. and Europe, and is designed to include 150 patients. The treatment group is being compared to the standard of care, which is palliative in nature, Solomon said.

Circe is expecting the study to be completed in the first quarter of 2000, he said. The patients are extremely sick and even with transplantation have a mortality rate of 40 percent to 50 percent, Solomon said. A 39-patient Phase I/II study of the HepatAssist System produced a 30-day survival rate of 90 percent, the same endpoint as in the pivotal study, Solomon said.

The system was developed in collaboration with researchers at the Cedars-Sinai Medical Center in Los Angeles, including Achilles Demetriou, the center¿s chairman of the Department of Surgery and holder of the Ester and Mark Schulman Chair in Surgery and Transplantation Medicine.

Among the management team at Circe is Claudy Mullon, vice president of operations and research and development; Zorina Pitkin, vice president of regulatory affairs; and Chris Stevens, director of medical affairs. All were involved when the project was at Grace. The company has 25 employees.

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