NEW YORK, Jan 21 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that updated results from its Phase 2 clinical trial of KRX-0401 (perifosine) in combination with capecitabine has been selected for poster presentation at the upcoming ASCO 2010 Gastrointestinal Cancers Symposium, to be held in Orlando, Florida from January 22-24, 2010.
The clinical data to be presented demonstrates the potential safety and efficacy of KRX-0401 in the treatment of patients with metastatic colon cancer.
A copy of the above referenced abstract can be viewed online through the American Society of Clinical Oncology's website, www.asco.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 pathway, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma, and in Phase 2 clinical development for several other tumor types. 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 expected to begin this quarter under an SPA agreement with the FDA. Keryx is headquartered in New York City.
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 Clinical Oncology's website is not incorporated by reference into this press release and is included as an inactive textual reference only.
Details on the poster presentation are as follows: Abstract #: 447 TITLE: A Randomized phase II study of perifosine in combination with capecitabine (P-CAP) versus capecitabine plus placebo (CAP) in patients with second- or third-line metastatic colon cancer (mCRC): Updated results Lead Author: Johanna Bendell, MD Session Name: General Poster Session C: Cancers of the Colon and Rectum Date: Sunday, January 24, 2010 Presentation Time: 7:00 AM - 8:00 AM; 12:00 NOON - 1:00 PM
SOURCE Keryx Biopharmaceuticals, Inc.