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Press release from PR Newswire

Phase 1 / 2 Clinical Trial Results of KRX-0401 (Perifosine) Plus Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Published in the Journal of Clinical Oncology

Thursday, October 13, 2011

Phase 1 / 2 Clinical Trial Results of KRX-0401 (Perifosine) Plus Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Published in the Journal of Clinical Oncology09:33 EDT Thursday, October 13, 2011Phase 3 Trial in Multiple Myeloma, under Special Protocol Assessment, and with Orphan Drug Status and Fast Track designation, is ongoingNEW YORK, Oct. 13, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") today announced that a manuscript entitled "Perifosine Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated with Bortezomib: Results of a Multicenter Phase l/2 Trial" reporting Phase 1 / 2 combination activity of KRX-0401 (perifosine) in the treatment of advanced multiple myeloma (MM) patients, was selected for publication in the October 11, 2011 online edition of the Journal of Clinical Oncology (JCO).  Perifosine, the Company's novel, potentially first-in-class, oral anti-cancer drug candidate that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway is currently being investigated in a Phase 3 trial comparing perifosine + bortezomib + dexamethasone versus placebo + bortezomib + dexamethasone in relapsed/refractory MM patients previously treated with bortezomib.  The ongoing Phase 3 study is being conducted under a Special Protocol Assessment (SPA), and with Orphan Drug Status and Fast Track designation in MM.  Perifosine is also currently in Phase 3 clinical development for refractory advanced colorectal cancer, also under an SPA and Fast Track designation.In this Phase 1 / 2 study, perifosine in combination with bortezomib +/- dexamethasone was evaluated in 84 heavily pre-treated patients with relapsed or relapsed/refractory MM.  All patients were required to receive prior bortezomib and most were bortezomib refractory (73%).  The combination demonstrated an overall response rate (ORR) including MR or > of 41% in all evaluable patients, with stable disease observed in an additional 41% of evaluable patients. The ORR was 65% for bortezomib-relapsed patients and 32% for patients with bortezomib-refractory disease. Median progression-free survival (PFS) was 6.4 months, with a median PFS of 8.8 months in the bortezomib-relapsed population.  Median overall survival (OS) was 25 months.  Therapy was generally well-tolerated; toxicities, including gastrointestinal side-effects and fatigue, proved manageable.  No treatment-related mortality was seen.  The investigators concluded that the combination of perifosine and bortezomib is active and well-tolerated in heavily pre-treated MM patients previously treated with bortezomib, and that the survival data in this study is encouraging, even in patients previously exposed to, and refractory to, bortezomib, as well as prior immunomodulatory drugs.Data from this study was previously presented at the 2009 American Society of Hematology (ASH) conference.A copy of the article featured in the current online edition of the Journal of Clinical Oncology can be obtained at http://jco.ascopubs.org/content/early/2011/10/04/JCO.2010.33.9788.full.pdf+htmlKRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. (NASDAQ: AEZS) in the United States, Canada and Mexico.About Keryx Biopharmaceuticals, Inc.Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA.  Keryx is headquartered in New York City.Cautionary StatementSome of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401 (perifosine); the risk that the data (both safety and efficacy) from the ongoing Phase 3 clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company, or will not meet the key efficacy and safety parameters specified in the Special Protocol Assessments; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the Journal of Clinical Oncology website is not incorporated by reference into this press release and is included for reference purposes only.KERYX CONTACT:Lauren FischerDirector - Investor RelationsKeryx Biopharmaceuticals, Inc.Tel: 212.531.5965E-mail: lfischer@keryx.comSOURCE Keryx Biopharmaceuticals, Inc.