NEW YORK, April 20 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that preclinical data in neuroblastoma for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR), currently being held in Washington, DC.
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The following poster will be presented in Exhibit Hall A-C on Wednesday, April 21, 2010, from 8:00am-11:00am:
Data demonstrating that single agent perifosine targets activation of Akt in neuroblastoma cells and xenografts, significantly inhibited tumor growth in vivo and improved the survival of mice bearing neuroblastoma tumors was originally presented at the 2009 AACR annual meeting by the same group from the Pediatric Oncology Branch of the National Institute of Health.
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A Phase I trial exploring the safety and efficacy of single agent perifosine in patients with pediatric tumors, including neuroblastoma, is currently being conducted by Memorial Sloan Kettering Cancer Center.
A copy of the above abstract is currently available and can be viewed on-line through the AACR 2010 Meeting website at: http://www.aacr.org/home/scientists/meetings--workshops/aacr-101st-annual-meeting-2010/abstracts.aspx.
KRX-0401 is currently in Phase 3 clinical development for refractory advanced colorectal cancer and multiple myeloma, both of these Phase 3 programs being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and in Phase 1 and 2 clinical development for several other tumor types.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. 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 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 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. 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 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. 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. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement 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 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; the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company; 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 AACR website is not incorporated by reference into this press release and is included for reference purposes only.
Abstract Number: 5248 Presentation Title: Neuroblastoma tumors with different ALK mutations are sensitive to Perifosine Poster Section: 16 Poster Board Number: 2 Author Block: Zhijie Li, Carol J. Thiele Cell & Molecular Biology Section POB/NCI/NIH, Bethesda, MD
SOURCE Keryx Biopharmaceuticals, Inc.
