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Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
Date:12/9/2008

rifosine + Bortezomib 52 1 2% 4 8% 3 6% 8 15% 12 23% With dex added* 28 0 0% 2 4% 6 12% 8 15% 11 21% Best Response N=52 1 2% 6 12% 9 17% 16 31% 23 44% (* as a subset of the evaluable population) **SD = greater than or equal to 4 cycles

Median TTP for all bortezomib-refractory patients was 6.2 months. Median TTP for responding patients has not yet been reached, currently it is 9.4 months and on-going.

Commenting on the data, Dr. Paul Richardson stated, "Perifosine appears to be particularly active with durable responses when combined with bortezomib and dexamethasone in a heavily pre-treated patient population. The encouraging response rate, impressive time to progression and manageable toxicity are especially favorable. We thus look forward to pursuing this combination in a randomized phase 3 trial."

Dr. Kenneth Anderson, Director of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute (DFCI) added, "We are excited at the results presented today as this data further confirms our early pre-clinical data demonstrating perifosine's ability to shut down bortezomib-activated AKT, which may help overcome bortezomib resistance."

Michael S. Weiss, Chairman and Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We are grateful for the dedication and diligence of the team of multiple myeloma investigators, led by Dr. Paul Richardson and Dr. Kenneth Anderson, who have rapidly translated pre-clinical findings into clinical results. In this heavily pre-treated patient population, the majority of whom had failed prior bortezomib-based therapy, we believe we have demonstrated that perifosine is an active, novel agent with the potential to provide clinical benefit to patients
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SOURCE Keryx Biopharmaceuticals, Inc.
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1. Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology
2. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
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