Lilly and Biosite to Collaborate on Clinical Trial Using Tailored Xigris Therapy
Trial to Study Use of Biomarker to Better Define Xigris Patients and Treatment Response
Eli Lilly and Company and Biosite® Incorporated announced the two companies have signed an agreement to collaborate in connection with a clinical trial employing a tailored therapy strategy for Lilly's severe 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.
Under the terms of 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 II-b clinical trial, which is expected to begin in the fourth quarter of 2006. Investigators also will use the tests in this novel study to help with individualized dose and duration of Xigris therapy and to evaluate patient response. The agreement also grants Biosite rights to intellectual property in the field of sepsis diagnosis, including assignment of U.S. Patent Application No. 10/759,216 Biomarkers for Sepsis. The financial terms of the agreement were not disclosed.
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