Keryx Biopharmaceuticals' KRX-0401 (Perifosine) Data Selected for Oral Presentation at the Upcoming 12th World Congress on Gastrointestinal Cancer
NEW YORK, June 29 /PRNewswire-FirstCall/ -- Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that abstract
O-0017, entitled "Subset Analysis of 5-FU Refractory Patients from
a Randomized Ph II Study of Perifosine + Capecitabine (P-CAP) vs.
Placebo + Capecitabine (CAP) in Patients with 2nd or 3rd Line
Metastatic CRC" has been selected for oral presentation at the
upcoming 12th World Congress on Gastrointestinal Cancer, to be held
in Barcelona, Spain from June 30 - July 2, 2010. The oral
presentation will be given by Paulo Hoff, M.D., Professor of
Medicine and Chairman of Medical Oncology at the University of Sao
Paulo, Brazil and former lead investigator for the capecitabine
(Xeloda(R)) Phase 3 approval study in metastatic colorectal
cancer.
Of the 38 patients enrolled in the Phase II study, 27 patients
were previously refractory to a 5-FU based regimen. A Phase 3
randomized double-blind trial comparing perifosine + capecitabine
vs. placebo + capecitabine in 5-FU refractory patients with
advanced refractory colorectal cancer (X-PECT trial), under Special
Protocol Assessment (SPA) from the FDA, is currently open and
enrolling patients at multiple centers throughout the U.S.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna
Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada
and Mexico.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is
the third most common form of cancer diagnosed in the United
States. It is estimated that over 146,000 people were diagnosed
with some form of colorectal cancer with over 49,000 patients dying
from colorectal cancer in 2009. Surgery is often the main treatment
for early stage colorectal cancer. When colorectal cancer
metastasizes (spreads to other parts of the body such as the liver)
chemotherapy is commonly used. Treatment of patients with recurrent
or advanced colorectal cancer depends on the location of the
disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with
or without bevacizumab) have been shown to increase survival rates
with some stages of colorectal cancer. Currently, there are seven
approved drugs for patients with metastatic colorectal cancer:
5-fluorouracil (5-FU), capecitabine (Xeloda(R)), irinotecan
(Camptosar(R)), oxaliplatin (Eloxatin(R)), bevacizumab
(Avastin(R)), cetuximab (Erbitux(R)) , and panitumumab
(Vectibix(R)). Depending on the stage of the cancer, two or more of
these types of treatment may be combined at the same time or used
after one another. For example, FOLFOX combines 5-FU, leucovorin
and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and
irinotecan. Avastin(R), a VEGF monoclonal antibody inhibitor, is
commonly administered together with FOLFIRI and FOLFOX. Typically,
patients who fail FOLFIRI and/or FOLFOX (+ Avastin) and who are
considered EGFR-positive (non-mutated, wild-type KRAS status),
receive the EGFR monoclonal antibody inhibitors Erbitux(R) or
Vectibix(R). However, patients who continue to progress beyond
these treatments have a poor prognosis.
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 Akt activation in the
phosphoinositide 3-kinase (PI3K) pathway, and also affects a number
of other key signal transduction pathways, including the JNK
pathway, all of which are pathways associated with programmed cell
death, cell growth, cell differentiation and cell survival.
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 is currently in Phase 3 clinical
development for both refractory advanced colorectal cancer and
multiple myeloma, and in Phase 1 and 2 clinical development for
several other tumor types. Each of the KRX-0401 Phase 3 programs
are being conducted under Special Protocol Assessment (SPA)
agreements with the FDA. 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.
The Phase 3 clinical program of Zerenex in the treatment for
hyperphosphatemia (elevated phosphate levels) in patients with
end-stage renal disease is being conducted pursuant to an SPA
agreement 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 trials 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 and cost-effectively complete clinical
trials for KRX-0401; the risk that the data (both safety and
efficacy) from ongoing clinical trials will not coincide with the
data analyses from prior pre-clinical and clinical trials
previously reported by the Company; 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 undertake 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 found on
our website is not incorporated by reference into this press
release and is included for reference purposes only.
KERYX CONTACT: Lauren Fischer Director - Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: lfischer@keryx.com
Source: Keryx Biopharmaceuticals, Inc.
CONTACT: Lauren Fischer, Director - Investor Relations,
Keryx
Biopharmaceuticals, Inc., +1-212-531-5965, lfischer@keryx.com
Web Site: http://www.keryx.com/
Posted: June 2010
