Phase 2 Study of KRX-0401 (Perifosine) in Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma Open for Enrollment at Duke Comprehensive Cancer Center

Phase 2 Study of KRX-0401 (Perifosine) in Relapsed or Refractory Chronic
Lymphocytic Leukemia / Small Lymphocytic Lymphoma Open for Enrollment at Duke
Comprehensive Cancer Center

NEW YORK, Oct. 8 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc.
(Nasdaq: KERX) announced today the initiation of a Phase 2 clinical study to
evaluate KRX-0401 (perifosine) as a single agent treatment for relapsed or
refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma
(SLL). This Phase 2 study was designed by Daphne Friedman, MD, Instructor and
Principal Investigator, in coordination with J. Brice Weinberg, Professor, and
Mark Lanasa, Assistant Professor, Divisions of Medical Oncology and
Hematology, Duke University Medical Center, and is currently open for
enrollment at Duke University. This study is being externally funded.

KRX-0401 (perifosine) is a novel, potentially first-in-class, oral anti-cancer
agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway and
several other key signal transduction pathways in both hematologic and solid
tumor cancers. Keryx is preparing to initiate a Phase 3 trial by year-end,
under Special Protocol Assessment (SPA), for patients with advanced multiple
myeloma.

Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented,
"We're very excited to explore the potential of perifosine in this advanced
CLL/SLL setting, based on the pre-clinical work completed by Dr. Weinberg."
Mr. Bentsur continued, "We are extremely grateful to the Duke Comprehensive
Cancer Center for conducting this study, and we look forward to working with
Drs. Friedman, Weinberg, Lanasa and their team of renowned oncologists on this
Phase 2 study."

STUDY RATIONALE:

CLL is characterized by the accumulation of circulating B cells which are
resistant to apoptosis. CLL has been found to have aberrant signaling in
several pathways including NF-kappaB, Akt/PI3K, and JNK/STAT pathways.
Published data has demonstrated that Akt is important in promoting CLL
survival and viability, as seen in in vitro experiments where blocking its
activity results in apoptosis. The effect of perifosine on CLL cells was first
tested in the laboratory of Dr. Brice Weinberg, which demonstrated the in
vitro cytotoxicity of perifosine on primary CLL cells. This data proving that
perifosine is an active agent against primary CLL cells, coupled with its
demonstrated safety profile in the clinical setting, provided the rationale
that perifosine should further be evaluated as a single agent in an advanced
CLL/SLL clinical setting.

STUDY DESIGN:

The single-center, open-label, study is entitled, "Phase 2 Trial of Perifosine
in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small
Lymphocytic Lymphoma," and will enroll approximately 30 patients. In this
study, perifosine will be given orally at a dose of 50 mg twice daily, for a
total of six 28-day cycles. The patients will be formally restaged upon
completion of the trial. Overall Response Rate is the primary endpoint with
overall survival, progression-free survival and safety as secondary endpoints.
Correlative studies will also be conducted and evaluated as a secondary
endpoint.

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

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of life-threatening diseases, including cancer and renal disease.
Keryx is developing KRX-0401 (perifosine), a novel, potentially
first-in-class, oral anti-cancer agent that inhibits the phosphoinositide
3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to
induce cell growth and cell transformation. KRX-0401 has demonstrated both
safety and clinical efficacy in several tumor types, both as a single agent
and in combination with novel therapies. 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, with a Phase 3 in multiple myeloma,
under Special Protocol Assessment (SPA), pending commencement by year-end.
Keryx is also 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, and Keryx is in the process of finalizing the U.S.
Phase 3 program for Zerenex in consultation with the FDA. 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 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 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:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
E-mail: lfischer@keryx.com

SOURCE Keryx Biopharmaceuticals, Inc.

Lauren Fischer, Director, Investor Relations of Keryx Biopharmaceuticals,
Inc., +1-212-531-5962, lfischer@keryx.com