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Keryx Biopharmaceuticals Announces Poster Presentation Highlighting Clinical Activity of KRX-0401 (Perifosine) at the 51st Annual Meeting of the American Society of Hematology

Posted on: Wednesday, 11 November 2009, 07:30 CST

NEW YORK, Nov. 11 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that data from its Phase 1/2 clinical trial of KRX-0401 (perifosine) in combination with bortezomib (+/- dexamethasone) has been selected for poster presentation at the upcoming 51st Annual Meeting of the American Society of Hematology (ASH), to be held in New Orleans from December 5-8, 2009. The clinical data to be presented demonstrates the potential safety and efficacy of KRX-0401 in the treatment of patients with relapsed/refractory multiple myeloma.

Details on the Abstract selected for poster presentation are as follows: Abstract #: 1869 TITLE: Perifosine in Combination with Bortezomib and Dexamethasone Extends Progression-Free Survival and Overall Survival in Relapsed/Refractory Multiple Myeloma Patients Previously Treated with Bortezomib: Updated Phase I/II Trial Results Lead Author: Paul Richardson, MD Session Name: Myeloma - Therapy, excluding Transplantation Poster I Date: Saturday, December 5, 2009 Presentation Time: 5:30 PM - 7:30 PM Location: Ernest N. Morial Convention Center, Hall E Poster Board no.: I-891

This abstract became available for viewing yesterday on the American Society of Hematology website (www.hematology.org). At the time of the abstract submission in mid-August 2009, there were 84 patients enrolled on study, of which 73 were evaluable for efficacy and are reported on within the abstract. Updated efficacy (response rate, time-to-progression and survival) and safety analyses, as of mid-November 2009, will be presented at the conference.

A copy of the above referenced abstract can be viewed online through the ASH website, www.hematology.org.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) 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 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 and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and Keryx is in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical 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 complete clinical trials for KRX-0401; our ability to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; 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 intend 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 in our website and in the American Society of Hematology's website is not incorporated by reference into this press release and is included as an inactive textual reference only.

KERYX CONTACT: Lauren Fischer Director - Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: lfischer@keryx.com

SOURCE Keryx Biopharmaceuticals, Inc.

Source: PR Newswire

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