Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) had disappointing news on March 7, 2008. They announced that their Sulonex SUN-MICRO Phase 3 clinical trial failed to meet the primary objective of the study. This Phase 3 trial was for the treatment of diabetic nephropathy.
Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, commented, “We are all very disappointed with the outcome of this study. While this represents the end of one chapter for Keryx, it is not the end of Keryx. Drug development is inherently risky and, accordingly, we have spent the last several years building what we believe to be a promising product portfolio in the event our lead drug failed. We plan to re-focus our primary efforts and resources on rapidly moving Zerenex forward for ESRD patients with hyperphosphatemia and Perifosine forward for cancer. Our goal is to have Perifosine in a pivotal program this year and be well into our Zerenex high-dose Phase 2 trial before the end of the year.”
According to the company’s website, the following drugs are in the developmental status: Zerenex Phase II, KRX-0401 Phase II, KRX-0402, KRX-0601, KRX-0404, KRK-0701, and KRX-0501. Keryx’s primary focus is on the acquisition, commercialization and development of medically important novel pharmaceutical products for the treatment of life-threatening diseases. The drugs they currently have in their pipeline are for the treatment of hyperphosphatemia for people with end-stage renal disease, multiple forms of cancer, diabetic neuropathy and neurological disorders.
The company states that KRX-0401, which is currently in Phase 2 clinical development, is expected to move into a Phase 3 clinical program in 2008.
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