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news.Keryx Biopharmaceuticals has said that Sulonex, the company's drug intended to treat diabetic nephropathy, has failed to meet primary objective of the Sun-Micro Phase III clinical trial.
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The objective of the study was to increase the proportion of patients that achieve therapeutic success at six months as compared to placebo over background therapy of maximal doses of ACE-inhibitors or ARBs. Therapeutic success was defined as conversion from microalbuminuria to normoalbuminuria, as measured by albumin or creatinine ratio (ACR), with at least a 25% reduction in ACR relative to baseline ACR, or a 50% reduction in ACR relative to baseline ACR. In addition, in reviewing the mean changes in ACR over time, Sulonex and placebo appeared to be similar.
Keryx plans to re-focus its primary efforts and resources on rapidly moving Zerenex forward for ESRD patients with hyperphosphotemia and Perifosine forward for cancer. The company’s goal is to have Perifosine in a pivotal program this year and be well into Zerenex high-dose Phase II trial before the end of 2008.”