Eli Lilly, Biosite team up on clinical trial using Xigris therapy

By Elaine Rigoli

Tampa, Fla., March 20 - Eli Lilly and Co. and Biosite, Inc. announced Monday their agreement to collaborate on a clinical trial using a tailored therapy strategy for Lilly's sepsis drug, Xigris (drotrecogin alfa [activated]).

The trial, called Respond (research evaluating serial Protein C levels in severe sepsis patients on drotrecogin alfa), will investigate the use of a multipurpose biomarker, Protein C, to be used in connection with the administration of Xigris to better define Xigris patients and treatment response, according to a company news release.

In November 2001, the Food and Drug Administration approved Xigris, a recombinant form of human-activated Protein C administered by intravenous infusion, for the reduction of mortality in adult patients with severe sepsis.

Under the agreement, Biosite will develop a rapid, point-of-care diagnostic capable of measuring Protein C levels. Lilly will use the Biosite test, as well as other existing FDA-approved Protein C tests, to enroll patients in its upcoming phase 2b clinical trial, which is expected to begin in the fourth quarter of 2006, the release said.

Investigators also will use the tests in this study to help with individualized dose and duration of Xigris therapy and to evaluate patient response.

The financial terms of the agreement were not disclosed.

Biosite is a biomedical company based in San Diego.

Based in Indianapolis, Eli Lilly is a pharmaceutical products organization.

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