The trial, named RESPOND, will investigate the use of a multipurpose biomarker, Protein C, to be used in connection with the administration of Xigris (drotrecogin alfa [activated]).
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 will also use the tests in this novel study to help with individualized dose and duration of Xigris therapy and to evaluate patient response.
In addition, the agreement grants Biosite rights to intellectual property in the field of sepsis diagnosis.
“This is an important strategic development recognizing the need for diagnostic tests that can be used to both identify patients who will benefit from therapeutic treatment and monitor their status over the course of time,” said Kim Blickenstaff, Biosite chairman and CEO.
“We are very excited about this collaboration,” added Dr John Lechleiter, president and COO for Lilly. “Physicians have told us they want an on-demand diagnostic that better identifies patients who might benefit from Xigris, helps monitor the patient’s response, and allows tailored treatment. We hope this biomarker strategy will help maximize the value of this medicine for critically ill sepsis patients.”