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Investigators From The Netherlands Cancer Institute Report Encouraging Results From Phase I Trial Of KRX-0401 (Perifosine) In Combination With Radiotherapy At The 2004 American Society of Clinical Oncology Annual Meeting


10/19/2005 5:11:38 PM

NEW YORK, June 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. announced today that Investigators from the Netherlands Cancer Institute reported encouraging results from a recently completed Phase I trial evaluating KRX-0401 (Perifosine), a novel, first-in- class, oral AKT inhibitor, in combination with radiotherapy in patients with unresectable locally advanced tumors. Poster #N3-3064, "Phase I Study of Combined Treatment with the Oral Alkyl-Lysophospholipid (ALP) Perifosine and Radiation in Patients with Advanced Solid Tumors," was presented this morning at the 2004 American Society of Clinical Oncology (ASCO) Annual Meeting in New Orleans, LA by Marcel Verheji, MD, of the Netherlands Cancer Institute.

This study was conducted because it is anticipated that Perifosine will provide synergistic effects when combined with established cancer treatments such as radiotherapy, chemotherapy, tyrosine kinase inhibitors and endocrine therapies. This study demonstrated that Perifosine and radiotherapy can be safely administered together and produced multiple complete and partial responses at all dosage levels tested.

This study was sponsored by our licensor, AEterna Zentaris, Inc. (TSX: AEZ; Nasdaq: AEZS), which holds ex-North American rights to the drug. A full press release on the data is available on their website http://www.aeternazentaris.com/.

KRX-0401 (Perifosine) is also currently being evaluated as a single agent in nine Phase II clinical trials in six tumor types being conducted by the National Cancer Institute (NCI) in accordance with a Collaborative Research and Development Agreement (CRADA).

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx is developing KRX-101 (sulodexide), a novel first-in-class oral heparinoid compound, for the treatment of diabetic nephropathy, for which Keryx recently commenced its U.S.-based Phase II/III clinical program. Additionally, Keryx is developing three clinical-stage oncology compounds including KRX-0401, a novel, oral, first-in-class AKT inhibitor in Phase II. Keryx also has an active in-licensing and acquisition program designed to identify and acquire clinical-stage drug candidates. Keryx Biopharmaceuticals is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future financial performance, timelines for the completion of the KRX-0401 clinical trial programs and the release of data from these programs, size of the programs, market size estimates for KRX-0401, growth and operating strategies and similar matters, are 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. Important factors may cause our actual results to differ materially, including: our ability to successfully complete cost-effective clinical trials of KRX-101 and KRX-0401; and other risk factors identified from time to time in our SEC reports, including, but not limited to, the report on Form 10-K for the year ended December 31, 2003, and our quarterly report on Form 10-Q for the quarter ended March 31, 2004. Any forward-looking statements set forth in this news release speak only as of the date of this news 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 Keryx's 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,Keryx Biopharmaceuticals, Inc., +1-212-531-5965, ron@keryx.com


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