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Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center
Date:7/14/2009

NEW YORK, July 14 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 1 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in pediatric patients. This Phase 1 study is now open for enrollment at Memorial Sloan-Kettering Cancer Center in New York City. Oren Becher, MD, Instructor, Department of Pediatrics, in coordination with Eric Holland, MD, PhD, Director of the Brain Tumor group at Memorial Sloan-Kettering Cancer Center, will act as the study's Principal Investigator. The study announced today is being fully funded by an external grant provided by a private organization.

KRX-0401 is a novel, oral, anticancer agent that modulates Akt and several other important signal transduction pathways. Keryx is currently in the process of finalizing late-stage protocols for Perifosine in the treatment of Multiple Myeloma and Metastatic Colon Cancer.

STUDY RATIONALE:

Activation of the PI3K/AKT pathway has been associated with poor prognosis, or proliferation, in several pediatric tumors such as neuroblastoma, glioblastoma, rhabdomyosarcoma, and medulloblastoma. Perifosine's inhibition of this and other pathways, as well as its ability to cross the blood-brain barrier has generated much interest in exploring its potential activity in the treatment of patients with advanced brain tumors. In vitro and in vivo data presented at AACR 2009 by investigators from the National Cancer Institute demonstrated that single agent perifosine not only induced tumor regression and delayed tumor growth, but that perifosine also improved the survival of mice bearing neuroblastoma tumors. Moreover, in a Phase 2 study conducted at Memorial Sloan-Kettering Cancer Center, perifosine induced responses and delayed disease progression in adult patients with advanced brain tumors.

Additionally, combination studies of perifosine with novel agents in patients with advanced brain tumors are expected to commence later this year. Such studies also to be funded by external grants.

Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We're very excited that Memorial-Sloan Kettering has taken on a leadership role in the first pediatric study of perifosine." Mr. Bentsur continued, "We are extremely grateful for the external financial support which we have received, and we look forward to working with Drs. Becher and Holland, and their team of renowned oncologists on this study."

STUDY DESIGN:

The single-center, open-label, Phase 1 study is entitled "Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors." In this study, perifosine is being evaluated as a single-agent in pediatric patients with any solid tumor that has failed standard therapy. Patients up to 18 years of age with a performance status of greater than 40% are eligible for this study. The study has been designed as a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3 to 6 patients at each dose level. All patients will receive perifosine at a loading dose on the first day, followed by a maintenance dose to start on day two until progression of disease. A minimum of 4 and a maximum of 24 patients will be required to complete the study.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.

About Recurrent Pediatric Tumors

Approximately 12,400 children and adolescents younger than 20 years of age are diagnosed with some type of cancer each year. Among these, approximately 2,300 children and adolescents die of cancer each year making cancer the most common cause of disease-related mortality for children 1 to 19 years of age. (NCI SEER Data) There are 12 major types of childhood cancers, and of these leukemias, brain and other central nervous system tumors (ie, gliomas and medulloblastomas) account for over 50% of the new cases. The remainder of new cases include extracranial tumors such as neuroblastomas, Wilms tumors, and rhabdomyosarcomas. Although improvements in imaging equipment and treatments have resulted in an overall decline in mortality and increased survival, approximately half of all children with malignant solid tumors will experience relapse and, of these children, less than 10% will achieve long-term survival after standard multimodal therapy.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM)(ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates 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. The Company also actively engages in business development activities that include seeking strategic relationships for its product candidates, as well as evaluating compounds and companies for in-licensing or acquisition. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for KRX-0401 (perifosine), 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 clinical trials for KRX-0401; our ability to successfully finalize late stage protocols for KRX-0401 with the FDA; our ability 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 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:
        Lauren Fischer
        Director, Investor Relations
        Keryx Biopharmaceuticals, Inc.
        Tel: 212.531.5962
        E-mail: lfischer@keryx.com


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SOURCE Keryx Biopharmaceuticals, Inc.
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