Navigation Links
Journal of Clinical Oncology Publishes Phase 2 Clinical Trial Results of KRX-0401 (Perifosine) Plus Capecitabine in Patients with Metastatic Colorectal Cancer
Date:10/5/2011

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.

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


'/>"/>
SOURCE Keryx Biopharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Atrium Announces the Publication of the COBEST Trial by the Journal of Vascular Surgery
2. Telik Announces Publication in the Journal Cancer of a Phase 2 Randomized Multicenter Study of Two Extended Dosing Schedules of Oral Ezatiostat in Low to Intermediate-1 Risk Myelodysplastic Syndrome
3. eCardio Among Honorees of the Houston Business Journals Fast 100 List for Second Consecutive Year
4. Elsevier Launches European Journal of Cancer iPad Edition
5. Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans® (Buprenorphine) Transdermal System CIII Published in The Journal of Pain
6. NxStage: NIH Study Published in New England Journal of Medicine Adds to Growing Body of Evidence in Support of More Frequent Hemodialysis
7. New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis
8. Zertane™ Clinical Results Published in the Journal European Urology
9. Lexicon Announces Publication of Results From the Phase 2 Trial of LX1031 in Patients With Irritable Bowel Syndrome in Journal of Gastroenterology
10. Cornerstone Pharmaceuticals Announces The Journal of Molecular Medicines Publication of Research Showing Selective Inhibition of Cancer Cell Energy Metabolism With Its Novel Lipoate Derivative Compounds
11. Study Published in Journal of Vascular Surgery Confirms Superiority of Artegraft BCA to Cuffed ePTFE for Hemodialysis Access
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... -- The global peripheral I.V. catheter market accounted for ... to grow at a CAGR of 6.0% during 2016-2022. ... share in the global market between the two types ... hospital segment accounted for the highest share in the ... I.V. catheter market is witnessing high growth rate, due ...
(Date:1/23/2017)... Endo International plc (NASDAQ / TSX: ENDP) and the ... motion in the U.S. District Court for the Northern ... entry of a ten-year Stipulated Order for Permanent Injunction.  ... and Endo relating to the patent infringement settlements Endo ... Lidoderm® products.  It also resolves the FTC,s claims against ...
(Date:1/23/2017)... MouthWatch LLC announced today that its flagship product, ... best intraoral camera on DentalCompare,s list of Top Dental ... #1 product was the CollaPlug Absorbable Collagen Wound Dressing ... "…incredibly popular because it is by far the most economical ... price, it doesn,t sacrifice quality imaging." ...
Breaking Medicine Technology:
(Date:1/24/2017)... ... January 23, 2017 , ... Texas Home Health, an ... two personal care service companies: Padre Home Health in Corpus Christi, Texas, and ... , Well regarded in their respective markets, these two agencies align with Texas ...
(Date:1/24/2017)... Clara, CA (PRWEB) , ... January 23, 2017 ... ... announces the launch of a new plugin that allows sleep centers to automatically ... Sleep Device Interface (SDI)—is a thin client browser plugin is quickly installed on ...
(Date:1/23/2017)... ... January 23, 2017 , ... PKF O’Connor Davies ... J. Nelson, a senior accountant at the Firm, will participate in the 40th Annual ... Over 200 runners will race up 1,576 steps, a vertical distance equal to about ...
(Date:1/23/2017)... (PRWEB) , ... January 23, 2017 , ... ... the highly acclaimed series, Innovations with Ed Begley, Jr., scheduled to broadcast Saturday, ... technology behind SmartCap, which was founded in 2008 to address the limitations of ...
(Date:1/23/2017)... ... January 23, 2017 , ... The Masters ... management and evaluation leaders with decades of experience who remain current practitioners in ... States healthcare system, there is a renewed demand for versatile, data-driven leadership.The American ...
Breaking Medicine News(10 mins):