Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at
June 02 2008 - 8:59AM
PR Newswire (US)
Phase 2 Results of Perifosine in the Treatment of Patients with
Relapsed/Refractory Waldenstrom's Macroglobulinemia to be presented
Tomorrow, Tuesday, June 3rd at 12:00pm in Room E450a NEW YORK, June
2 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc.
(NASDAQ:KERX) today announced that abstracts related to KRX-0401
(Perifosine) have been selected for both poster presentation and
publication during the American Society of Clinical Oncology
Meeting currently taking place in Chicago, Illinois (May 31 - June
3, 2008). Copies of these abstracts, which highlight the observed
clinical and preclinical activity of KRX-0401 as a single agent and
in combination with novel agents are currently available and can be
viewed on-line through the ASCO website:
http://www.asco.org/ASCO/Abstracts+%26+Virtual+Meeting/Abstracts
The following abstract will be available for viewing during the
poster session taking place tomorrow, Tuesday, June 3, 2008, from
8:00am-12:00pm: Abstract 8546: A Phase 2 trial of the novel oral
Akt inhibitor perifosine in relapsed and/or refractory Waldenstrom
macroglobulinemia Investigators: Irene M. Ghobrial, X. Leleu, N.
Rubin, R. Leduc, S. Chuma, M. Nelson, P. G. Richardson, S. P.
Treon, K. C. Anderson Following the poster session, lead
investigator, Dr. Irene Ghobrial, will be presenting the abstract
during the Lymphoma and Plasma Cell Disorders Poster Discussion
Forum, scheduled to take place at 12:00pm in Room E450a.
Additionally, the following abstracts have been accepted for
publication only: Abstract 16024: Phase 1 multicenter trial of
perifosine in combination with sorafenib for patients with advanced
cancers including renal cell carcinoma. Investigators: M. T.
Schreeder, R. A. Figlin, J. J. Stephenson, L. Campos, S. P. Chawla,
D. R. Spigel, A. Spira Abstract 14565: Phase 1 report from a
multicenter trial of perifosine (PERI) + sunitinib (SUT) in
patients with advanced cancers including renal cell carcinoma.
Investigators: P. Allerton, B. Ebrahimi, M. T. Schreeder, P.
Kaiser, S. P. Chawla Abstract 16083: Preclinical rationale for
combination targeted therapy in advanced clear cell renal cell
carcinoma (RCC): Abrogation of rapamycin-mediated induction of AKT
phosphorylation by perifosine. Investigators: W. S. Holland, P. C.
Mack, D. R. Gandara, P. N. Lara KRX-0401 (Perifosine) Mechanism of
Action and Profile KRX-0401 (Perifosine) is a novel, potentially
first-in-class, oral anti-cancer agent that modulates Akt and a
number of other key signal transduction pathways, including the JNK
and MAPK pathways, all of which are pathways associated with
programmed cell death, cell growth, cell differentiation and cell
survival. The effects of perifosine on Akt are of particular
interest because of the importance of this pathway in the
development of most cancers, the evidence that it is often
activated in tumors that are resistant to other forms of anticancer
therapy, and the difficulty encountered thus far in the discovery
of drugs that will inhibit this pathway without causing excessive
toxicity. High levels of activated Akt (pAkt) are seen frequently
in many types of cancer and have been correlated with poor
prognosis in patients with soft-tissue sarcoma, gastric,
hepatocellular, endometrial, prostate, renal cell, head and neck
cancers and hematological malignancies, as well as glioblastoma.
The majority of tumors expressing high levels of pAkt were
high-grade, advanced stage or had other features associated with
poor prognosis. High pAkt is often seen in tumors that are
resistant to conventional cancer treatments, including
radiotherapy, chemotherapy, endocrine therapy, and especially
therapy with some of the newer biologicals. To date, over 1,700
patients have been treated with KRX-0401 in trials conducted both
in the United States and Europe. Its safety profile is distinctly
different from that of most cytotoxic agents. It does not appear to
cause myelosuppression (depression of the immune system that may
lead to life threatening infections), thrombocytopenia (a decrease
in platelets that may result in bleeding), skin rash, flu-like
symptoms or alopecia (hair loss); all of these toxicities occur
frequently with many of the currently available treatments for
cancer. The main side effects of perifosine are nausea, vomiting,
diarrhea and fatigue, but these are either mild or non-existent in
lower doses that have induced tumor regression. Responses have been
seen with both daily and weekly regimens. At the doses studied, the
daily regimens were better tolerated. In Phase 1/2 trials, KRX-0401
has induced tumor regressions and/or caused disease stabilization
in a variety of tumor types. KRX-0401 has shown single agent
partial responses in renal cell and hepatocellular carcinoma, soft
tissue sarcoma, GIST tumors, mesothelioma, and carcinoma of the
appendix. There is also evidence of activity in hematological
malignancies, especially multiple myeloma. Disease stabilization,
defined as time on treatment without progression for at least 6
months has been seen in 20 tumor types, including metastatic renal
cell cancer, hepatocellular carcinoma, melanoma, carcinoid,
prostate, head and neck, breast, and small cell lung cancer.
Responding patients, including stable disease, have been treated
for various durations up to more than three years. KRX-0401
(perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc.
(Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
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 is currently in Phase 2
clinical development for the treatment of hyperphosphatemia
(elevated phosphate levels) in patients with end-stage renal
disease, or ESRD. 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 has an 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 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 1 and
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 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: 212.531.5965 E-mail:
DATASOURCE: Keryx Biopharmaceuticals, Inc. CONTACT: Lauren Fischer,
Director - Investor Relations, Keryx Biopharmaceuticals, Inc.,
+1-212.531.5965, Web site: http://www.keryx.com/
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