Healthcare Industry News:  Multiple Myeloma  

Biopharmaceuticals Oncology

 News Release - January 3, 2006

Keryx Biopharmaceuticals, Inc. Commences Phase II, Multi-Center Study of KRX-0401 for the Treatment of Refractory Multiple Myeloma

Dana-Farber Cancer Institute to Lead Study
Additional Single Agent and Combination Trials in Hematological Tumors to Follow


NEW YORK, Jan. 3 (HSMN NewsFeed) -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) announced today the initiation of a corporate-sponsored clinical program to evaluate KRX-0401 (perifosine) as a treatment for multiple myeloma. This follows positive pre-clinical data presented last month at the Annual Meeting of the American Society of Hematology (ASH) where perifosine was shown to be active against human Multiple Myeloma cell lines and freshly isolated plasma cells from Multiple Myeloma patients' bone marrow, including those cells which were resistant to dexamethasone and doxorubicin. Perifosine was shown to modulate a number of key cellular functions involved in the replication and death of Multiple Myeloma cells, and, as in other cell lines, it was shown to be a potent Akt inhibitor. Perifosine was active in vitro and in vivo when used alone, and it appeared to be synergistic when combined with either bortezomib (VelcadeŽ) or dexamethasone.

The clinical trial initiated today is entitled "An Open-Label Phase II Study of the Safety and Efficacy of Perifosine [KRX-0401] Alone and in Combination with Dexamethasone for Patients with Relapsed or Relapsed/Refractory Multiple Myeloma". This is a multi-center study led by Dr. Paul Richardson, Clinical Director of the Jerome Lipper Myeloma Center at the Dana-Farber Cancer Institute (DFCI) in Boston, MA.

In this Phase II study, patients with relapsed or relapsed/refractory Multiple Myeloma will be treated with KRX-0401 (150 mg oral daily dose) to assess the single agent activity of KRX-0401 in this patient population. If a patient progresses on KRX-0401 alone, dexamethasone (20mg twice weekly) will be added to their KRX-0401 regimen. This study is similar in design to the VelcadeŽ pivotal Phase II program, the SUMMIT study, for which Paul Richardson also served as Principal Investigator.

Dr. Richardson stated, "KRX-0401 is a novel compound with a unique mechanism of action that has demonstrated compelling activity in what we believe are highly predictive Multiple Myeloma preclinical models. We are eager to explore its potential in treating and hopefully benefiting our patients with relapsed or relapsed/refractory myeloma."

Nancy Sumberaz, President, Multiple Myeloma Research Foundation, remarked, "The advancement of perifosine into Phase II clinical trials is an encouraging step forward for Multiple Myeloma patients. Having helped fund early studies of perifosine through our research grants program, we are extremely proud to have played an important role in the development of this potential new treatment for multiple myeloma."

Craig Henderson, MD, President of Keryx Biopharmaceuticals, commented, "We are very excited about the KRX-0401 preclinical results in multiple myeloma, and are pleased to see top institutions in the field coming together with leadership from Dr. Ken Anderson and his group at the Farber to conduct this important clinical program." Dr. Henderson added, "We believe that KRX-0401 may be very effective in hematological malignancies because they are initially very sensitive to standard cytotoxic drugs but eventually become resistant because abnormalities develop in signal transduction pathways that are affected by KRX-0401, especially the Akt pathway."

Michael S. Weiss, Chairman and Chief Executive Officer of Keryx, added, "I am extremely pleased with the rapid translation of preclinical information into human clinical trials. It demonstrates what can be accomplished when industry, academia and advocacy groups work together to move drugs forward. With DFCI's track record of having preclinical models predict active agents in multiple myeloma, we are hopeful and optimistic that KRX-0401 can make a positive contribution to the treatment of patients with multiple myeloma."

Another Keryx-sponsored Multiple Myeloma clinical study to be launched in the first half of 2006 will be a DFCI -led phase I/II study evaluating the safety and efficacy of KRX-0401 and bortezomib (VelcadeŽ) therapy with or without dexamethasone for patients with relapsed or refractory Multiple Myeloma previously treated with bortezomib (VelcadeŽ).

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (TSX: AEZ ; Nasdaq: AEZS ), 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 stablizations 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. 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.


Source: Keryx Biopharmaceuticals

Issuer of this News Release is solely responsible for its content.
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