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Phase 2 Trial Results for Exelixis' XL784 Presented at the 2007 American Society of Nephrology Conference
Date:11/2/2007

SAN FRANCISCO, Nov. 2 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) today presented data from its phase 2 clinical trial of XL784 in subjects with albuminuria due to diabetic nephropathy. XL784 is a small molecule inhibitor of ADAM-10 and MMP-2, metalloprotease enzymes that may play a role in the pathogenesis of diabetic nephropathy and renal fibrosis. The data were presented during a poster session (Abstract/Poster PO1030) at the American Society of Nephrology Renal Week 2007 meeting in San Francisco. The company previously announced that the clinical trial did not meet its primary endpoint.

125 subjects were enrolled into this randomized, double-blind, placebo-controlled study. XL784 (200mg once daily for 12 weeks) was compared to placebo in subjects with macro-albuminuria who were being treated concurrently with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB).

The primary endpoint was the reduction from baseline in the urinary albumin to creatinine ratio (ACR) at Week 12. Proteinuria, the presence of excess protein in the urine, is an indicator of renal disease. Albumin excretion is a risk factor for kidney failure, stroke and cardiovascular and all-cause mortality, particularly in patients with diabetes and/or hypertension. Nephropathy (kidney disease) is a common problem in diabetic patients, often leading to the need for hemodialysis or kidney transplant.

After 12 weeks of treatment with XL784 the baseline normalized ACR (end of treatment/baseline ACR) in the XL784 group was 9.9% lower than that in the placebo group (not significant). There was a clinically relevant mean ACR reduction from baseline of 23% (p=0.0027) in subjects randomized to XL784. The change in glomerular filtration rate (GFR) at Week 12 was -2.5 ml/min/1.73m2 in the XL784 group and -6.2 ml/min/1.73m2 in the placebo group (p=0.077).

In an exploratory analysis, subjects were stratified according to dose of ACEi
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SOURCE Exelixis, Inc.
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