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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

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK pathway, which are pathways associated with programmed cell death, cell growth, ce
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SOURCE Keryx Biopharmaceuticals, Inc.
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Related medicine technology :

1. Keryx Biopharmaceuticals to Present at William Blair & Company Small-Cap Growth Stock Conference
2. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
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
5. Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint
6. Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial
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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