NEW YORK, Dec. 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that abstracts related to KRX-0401 (Perifosine) have been selected for presentation during the poster sessions scheduled to take place at the upcoming American Society Hematology Meeting and exposition taking place at the Georgia World Congress Center in Atlanta, Georgia (December 8-11, 2007).
Copies of these abstracts, which highlight the observed clinical activity of KRX-0401 in the treatment of patients with relapsed/refractory multiple myeloma are currently available and can be viewed on-line through the ASH website: http://www.abstracts2view.com/hem07/
The following abstracts will be presented on Saturday, December 8, 2007 at 5:30pm:
[1164] - Board #318-I
Multi-Center Phase II Study of Perifosine (KRX-0401) Alone and in Combination with Dexamethasone (dex) for Patients with Relapsed or Relapsed/Refractory Multiple Myeloma (MM): Promising Activity as Combination Therapy with Manageable Toxicity.
Paul Richardson, S. Lonial, A. Jakubowiak, A. Krishnan, J. Wolf, J. Densmore, S. Singhal, I. Ghobrial, J. Stephenson, J. Mehta, K. Colson, D. Francis, T. Kendall, N. Obadike, K. Sullivan, J. Martin, T. Hideshima, L. Lai, P. Sportelli, L. Gardner, R. Birch, I.C. Henderson, K. Anderson
[1169] - Board #323-I
A Multiple Myeloma Research Consortium (MMRC) Multicenter Phase I Trial of Perifosine (KRX-0401) in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (MM): Updated Results.
Andrzej Jakubowiak, Todd Zimmerman, Melissa Alsina, Paul Richardson, Jonathan Kaufman, T. Kendall, C. Brozo, A. McAllister, C. Leister, T. Hideshima, P. Sportelli, L. Gardner, R. Birch, I.C. Henderson, K. Giusti, Kenneth Anderson
[1170*] - Board #324-I
Phase I/II Report from a Multicenter Trial of Perifosine (KRX-0401) + Bortezomib in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma Previously Treated with Bortezomib.
Paul Richardson, A. Jakubowiak, J. Wolf, J. Allerton, J. Zonder, S. Lonial, A. Krishnan, J. Densmore, I. Ghobrial, K. Colson, T. Kendall, C. Leister, B. Martineau, T. Hideshima, T. Facon, P. Sportelli, L. Gardner, R. Birch, I.C. Henderson, K. Anderson
* Data reflected in Abstract 1170 is updated on Poster Board #324-1
Perifosine (KRX-0401) Mechanism of Action and Profile
Perifosine has been shown to inhibit or otherwise modify signaling through a number of different signal transduction pathways including Akt, MAPK, and JNK. Akt isoforms have been found to be overexpressed in renal, breast, prostate, and pancreatic cancers. Elevated levels of pAkt have been correlated with poor prognosis in patients with gastric, hepatocellular, endometrial, prostate, renal cell and head and neck cancers, as well as glioblastoma. The majority of tumors expressing high levels of pAkt were high-grade, advanced stage or had other features associated with poor prognosis.
The effects of perifosine on Akt are of particular interest because of 1) the importance of this pathway in the development of most cancers; 2) the evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy; and 3) and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity.
To date, over 1,500 patients have been treated with perifosine in trials conducted both in the US and Europe. Its safety profile is distinctly different from that of most cytotoxic agents. It does not cause myelosuppression (depression of the immune system) or alopecia (hair loss) like many currently available treatments for cancer. In phase I/II trials it has induced tumor regressions and/or caused disease stabilization in a variety of tumor types. Responding patients, including stable disease, have been treated for months to almost 3 years, on both the daily and weekly schedule.
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, Inc. is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx’s lead compound under development is Sulonex(TM) (sulodexide oral gelcap), previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, iron- based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end-stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401, a novel, first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth, and 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. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future the financial performance and clinical and business prospects for KRX-0401, 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 the Phase 1 and Phase 2 clinical trials for KRX-0401; we may not be able 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 is not incorporated by reference into this press release and is included as an inactive textual reference only.
lfischer@keryx.com
CONTACT: Lauren Fischer, Director of Investor Relations of Keryx
Biopharmaceuticals, Inc., +1-212-531-5965, lfischer@keryx.com
Web site: http://www.keryx.com/
http://www.abstracts2view.com/hem07/
