Exelixis Reports Top-Line Results of the Phase 2 Trial of XL784 in Patients With Proteinuria Associated With Diabetic N...( - Data to be presented November 2 a...),Health

- Data to be presented November 2 at the American Society of Nephrology

Meeting -

SOUTH SAN FRANCISCO, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) announced that a recently completed phase 2 trial of XL784 did not meet its primary endpoint of reducing proteinuria compared with placebo in patients with proteinuria associated with diabetic nephropathy. Exelixis is continuing to analyze the data to assess whether further evaluation of the compound is warranted.

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. XL784 is a potent small molecule inhibitor of MMP2 and ADAM10, metalloprotease enzymes that may play a role in renal fibrosis and impairment.

"We obviously are disappointed that this trial did not meet its primary endpoint," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "However, the compound was well tolerated, and we are continuing to analyze the data to determine if the compound may have utility in the treatment of diabetic nephropathy. We will provide an update on our plans for XL784 once we complete our analysis of the data."

The complete safety and efficacy data from the phase 2 trial of XL784 in diabetic patients with proteinuria are scheduled for presentation on November 2, 2007, at the American Society of Nephrology (ASN) Renal Week 2007, which is b
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