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Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
Date:12/16/2009

. The Phase 3 trial design is based on positive data reported from the Phase 1/2 trial which was recently reported at the 51st American Society of Hematology meeting. Patients eligible for the Phase 3 trial must have been previously treated with both bortezomib (VELCADE® ) and an immunomodulatory agent (REVLIMID® and/or THALIDOMID® ), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Patients can be relapsed from and refractory to all non-bortezomib based therapies, however, patients can only be relapsed (progressed > 60 days after discontinuing therapy) from prior bortezomib-based therapies. The study is powered at 90% to demonstrate the required difference in progression-free survival between the two arms. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data.

The Company expects a patient recruitment period of approximately 16-18 months, with study completion within approximately 20-22 months from today.

The trial is being conducted under a Special Protocol Assessment with the FDA.

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.
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SOURCE Keryx Biopharmaceuticals, Inc.
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3. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
4. Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
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7. 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
8. 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
9. Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
10. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
11. Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401s Activity in the Treatment of Advanced Metastatic Renal Cell Cancer
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