NEW YORK, Dec. 8 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that Dr. Hideshima, of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and a member of Dr. Kenneth C. Anderson’s research team, will report the results of preclinical experiments that demonstrate the effectiveness of KRX-0401 (perifosine) against multiple myeloma (MM) cells at the upcoming American Society of Hematology (ASH) 47th Annual Meeting and Exposition in Atlanta, Georgia (December 10-13, 2005). Dr. Anderson’s group was instrumental in the development of Velcade(R), an approved drug for MM, and Revlimid(R), a drug pending potential approval for MM. Dr. Hideshima’s presentation, entitled “Perifosine, an Oral Bioactive Novel Alkyl-Phospholipid, Inhibits Akt and Induces In Vitro and In Vivo Cytotoxicity in Human Multiple Myeloma (MM) Cells,” is scheduled to begin at 8:15am EST on Monday, December 12th, 2005 in the Sidney Marcus Auditorium of the Georgia World Congress Center.
KRX-0401, the Company’s lead oncology compound under development, is a novel, oral, anticancer agent that modulates Akt and several other important signal transduction pathways, including MAP kinase and JNK. KRX-0401 is currently being evaluated in Phase II clinical trials as a single agent and in combination with other anti-cancer agents across several tumor types.
Commenting on the data generated by his lab at Dana-Farber (DFCI), Dr. Anderson, Director of DFCI’s Jerome Lipper Multiple Myeloma Center and Chief of the Division of Hematologic Neoplasia, stated “We are excited that the pre- clinical results of perifosine, alone and in combination with other conventional agents, suggest this oral agent, with a novel mechanism of action, may offer a new approach to treatment-resistant patients with multiple myeloma. We look forward to moving perifosine into planned clinical trials in the near future.”
This presentation will not be webcast.
In addition to Dr. Hideshima’s oral presentation, an additional six studies of KRX-0401 (perifosine) will be presented during the ASH poster sessions. These abstracts include:
* 1488 Combination of Farnesyl Transferase Inhibitor (Tipifarnib) with Perifosine Induces Apoptosis through phos-PDK1 in Human Lymphoma and Leukemia Cell Lines. Ebenezer David, Rajni Sinha, Claire Torre, Jonathan L. Kaufman, Sagar Lonial * 1568 Combination of Akt/PKB Inhibition (Perifosine) and Farnesyl Transferase Inhibition (Tipifarnib) Results in Increased Cell Death in Myeloma Cells Lines. Rajni Sinha, Ebenezer David, Emily Zeilter, Claire Torre, Jonathan L. Kaufman, Sagar Lonial * 1579 Alkylphosphocholine Perifosine Inhibits Myeloma Cell Growth While Inducing Myeloid Hyperplasia in a Murine Myeloma Model. Laurence Catley, Teru Hideshima, Dharminder Chauhan, Paola Neri, Piefrancesco Tassone, Yu-Tzu Tai, Weihua Song, Daniel R. Carrasco, Nikhil C. Munshi, Kenneth C. Anderson * 1592 Combination of the AKT Inhibitor Perifosine with the HSP90 Inhibitor 17-(Dimethylaminoethylamino)-17-Demethoxygeldanamycin (17-DMAG) Has Synergistic Activity in Multiple Myeloma (MM). Alissa Huston, Lanie Francis, Yazan Alsayed, Ujjal Singha, Ganwei Lu, Judy Anderson, Suzanne Lentzsch, G. David Roodman, Irene Ghobrial * 2509 The Role of the AKT Inhibitor Perifosine in Migration and Adhesion in Multiple Myeloma (MM). Alissa Huston, Ujjal Singha, Yazan Alsayed, Lanie Francis, Ganwei Lu, Judy Anderson, Suzanne Lentzsch, G. David Roodman, Irene M. Ghobrial * 3402 Proteomic Analysis Identifies Differences in Multiple Myeloma (MM) Cells Sensitive and Resistant to AKT Inhibition. Alissa Huston, Alexey Leontovich, Michael Timm, Yazan Alsayed, Ujjal Singha, Lanie Francis, Ganwei Lu, Judy Anderson, Suzanne Lentzsch, Irene Ghobrial
Dr. Craig Henderson, President of Keryx, stated, “We believe that the data to be presented at ASH demonstrates the potential utility of KRX-0401 as a single-agent and in combination with other anti-cancer therapies in the treatment of multiple myeloma and leukemia. We are excited about the data that will be presented at ASH. This is the first time that perifosine has been evaluated in non-solid tumors and the results are quite compelling, even though they are still pre-clinical. We will launch human studies in the very near future to see if the beneficial effects seen in these preclinical models can be replicated in patients with multiple myeloma. The data from the studies to be presented at ASH along with the data presented late last month at the AACR/NCI/EORTC new drugs conference reinforce our enthusiasm for perifosine as an anti-cancer agent with great promise. We look forward to obtaining a first look at data from our on-going clinical program over the next several months.”
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. It has demonstrated preliminary single agent anti-tumor activity and is currently in a phase II clinical program where it is being studied both as a single agent and in combination with other anti-cancer treatments for multiple forms of 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. Additionally, Keryx is developing clinical-stage oncology compounds, including 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: Ron Bentsur Vice President - Finance & Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: ron@keryx.com
Keryx Biopharmaceuticals, Inc.
CONTACT: Ron Bentsur, Vice President - Finance & Investor Relations, KeryxBiopharmaceuticals, Inc., +1-212-531-5965, ron@keryx.com
