NEW YORK, March 2 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. announced today the initiation of a corporate-sponsored Phase 2, multi-center, clinical program to evaluate KRX-0401 (perifosine) as a treatment for leukemia. The principal investigator for the study is Dr. Frank Giles, Professor, Department of Leukemia, at the MD Anderson Cancer Center in Houston, TX. This is the second study to be launched under the company’s corporate sponsored hematological clinical program, which was announced earlier this year in connection with the initiation of a multi-center Phase II study evaluating perifosine as a treatment for multiple myeloma.
This clinical trial, entitled “Phase II Study of Perifosine in Patients with Refractory and Relapsed Leukemia,” will assess the objective response rate and evaluate the pharmacokinetics and safety and tolerability of perifosine as a single agent in relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), high-risk myelodysplastic syndrome (MDS) and chronic myeloid leukemia in the blastic phase.
Dr. Giles stated, “We are delighted to have begun to treat patients suffering from refractory leukemia with perifosine”, said Professor Frank Giles, Chief of Developmental Therapeutics at the University of Texas MD Anderson, Department of Leukemia. “There is an increasing focus on inhibition of the AKT pathway as a potentially rewarding anti-leukemia approach. The clinical and pre-clinical data gathered on this study will help to assess AKT as a potential target, and will tell us if perifosine is useful for these patients, who desperately need an improvement over current therapies.”
I. Craig Henderson, MD, President of Keryx Biopharmaceuticals, commented, “We are extremely pleased to have Dr. Giles and his group at MD Anderson leading this important trial in relapsed and refractory leukemia, an area of high unmet medical need. Strong pre-clinical research supports the rationale for KRX-0401 as a potential treatment for leukemia in patients who have become resistant to other drugs.”
Michael S. Weiss, Chairman and Chief Executive Officer of Keryx, added, “I am very pleased that our hematological clinical program for KRX-0401 continues to expand. We hope that KRX-0401 will have a positive impact on the treatment of patients with leukemia,” Mr. Weiss added, “The initiation of the study today is another example of our ability to garner the support and involvement of the top cancer centers in the design and implementation of our studies.”
The company anticipates launching additional hematological studies in the first half of 2006, including another corporate-sponsored DFCI -led phase I/II study evaluating the safety and efficacy of KRX-0401 and bortezomib (Velcade(R)) therapy with or without dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with bortezomib (Velcade(R)).
KRX-0401 (perifosine) is in-licensed by Keryx from AEterna Zentaris, Inc. , in the United States, Canada and Mexico.
About KRX-0401 (Perifosine)
KRX-0401 is a novel, first-in-class, oral anticancer agent that modulates AKT and a number of other key signal transduction pathways, including the MAPK and JNK pathways. Perifosine has shown single agent partial responses or long term disease stabilizations in solid tumors including sarcoma and prostate cancer.
KRX-0401, or perifosine, is the prototype of a new group of anti-cancer drugs referred to as alkylphosphocholines that block proliferation and induce the apoptosis of cancer cells. This effect is relatively specific for cancer cells compared to normal cells. The mechanism of action for these drugs is not clear. They are known to modulate signaling in a number of pathways known to function abnormally during the development of cancer. One of the pathways inhibited by the alkylphosphocholines is Akt, a pathway associated with tumor survival and growth. Akt is considered to be one of the most important cancer targets being researched today.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx’s lead compound under development is KRX-101 (sulodexide), a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life- threatening kidney disease caused by diabetes. KRX-101 is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. Keryx is also developing additional clinical stage compounds, including Zerenex(TM), which is currently in Phase II clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease (ESRD) and KRX-0401, a novel, first- in-class oral modulator of Akt, a pathway associated with tumor survival and growth, and other important signal transduction pathways. 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 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 Commissions. 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.
KERYX CONTACT: Ronald C. Renaud, Jr. Senior Vice President & Chief Financial Officer Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: rrenaud@keryx.com
Keryx Biopharmaceuticals, Inc.
CONTACT: Ronald C. Renaud, Jr., Senior Vice President & Chief FinancialOfficer of Keryx Biopharmaceuticals, Inc., +1-212-531-5965,rrenaud@keryx.com
Web site: http://www.keryx.com/
