Journal of Clinical Oncology Publishes Phase 2 Clinical Trial Results of KRX-0401 (Perifosine) Plus Capecitabine in Patients with Metastatic Colorectal Cancer
Ongoing Phase 3 Trial under Special Protocol Assessment, and with Fast Track designation is fully enrolled
NEW YORK, Oct. 5, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") today announced that a manuscript entitled "Randomized Placebo-Controlled Phase II Trial of Perifosine Plus Capecitabine as Second- or Third-Line Therapy in Patients with Metastatic Colorectal Cancer" reporting Phase 2 activity of KRX-0401 (perifosine) in the treatment of patients with refractory, advanced colorectal cancer (mCRC), was selected for publication in the October 3, 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 entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment),which is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine. The Phase 3 X-PECT study is being conducted under a Special Protocol Assessment (SPA), and with Fast Track designation. In July, the Company announced the completion of enrollment into the Phase 3 X-PECT study, with approximately 465 patients in the United States randomized. Approximately 360 events of death will trigger the un-blinding of the study. Study completion is expected in 1Q 2012.
The JCO publication highlights the efficacy and safety data on the 38 mCRC patients participating in this Phase 2, randomized, multicenter study, comparing perifosine plus capecitabine (P-CAP) to placebo plus capecitabine. Based on the data, in which the combination of P-CAP demonstrated statistical significance with respect to median overall survival and median time to tumor progression, the investigators concluded that the P-CAP combination showed promising clinical activity compared to single-agent capecitabine, and that the difference in clinical outcome seen with the addition of perifosine was impressive.
Efficacy data from this study was previously presented in June 2010 at the 46th Annual Meeting of the American Society of Clinical Oncology.
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/2011/10/03/JCO.2011.36.1980.abstract
Perifosine is also currently in a Phase 3 trial, under SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted.
KRX-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 other signal transduction pathways, including the JNK pathway, believed to be associated with cell death, growth, differentiation and 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 Food and Drug Administration (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 in the treatment for 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.
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 (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.
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
SOURCE Keryx Biopharmaceuticals, Inc.
Web Site: http://www.keryx.com
Posted: October 2011