Group
|
n
(%)
|
PR
n
(%)
|
Duration
of
Response
|
>
SD
(min 12 wks)
n
(%)
p=0.066
|
PD 10% incidence
for the P-CAP arm versus CAP arm as follows: hand-foot syndrome
(30% vs. 0%), anemia (15% vs. 0%), fatigue (0% vs. 11%) and
abdominal pain (5% vs. 11%). Of note, incidence of Grade 1
and 2 hand-foot syndrome was similar in both the P-CAP and CAP arms
(25% vs. 22%, respectively). Hand-foot syndrome is a reported
adverse event with capecitabine monotherapy. Patients who
remained on treatment longer in the Phase 2 study had a greater
chance to develop hand-foot syndrome as illustrated by a median
time to onset of Grade 3 and 4 hand-foot syndrome in the P-CAP arm
of 19 weeks.
Based on the Phase 2 data, a Phase 3
randomized double-blind trial comparing perifosine + capecitabine
vs. placebo + capecitabine in patients with advanced refractory
colorectal cancer (X-PECT trial), under Special Protocol Assessment
(SPA) from the FDA, is open and enrolling patients at multiple
centers throughout the US.
Commenting on the data, Dr.
Johanna Bendell, Director of GI
Oncology Research at Sarah Cannon Research Institute in
Nashville, TN, stated, "As the
final randomized Phase 2 data confirmed the promising activity of
perifosine plus capecitabine compared to placebo plus capecitabine,
I believe the ongoing X-PECT trial will soon provide us an answer
as to the role of perifosine in the treatment of patients with
refractory colorectal cancer." Dr. Bendell is the Principal
Investigator for the Phase 3 X-PECT trial.
Dr. Cathy Eng, Associate
Medical Director for Colorectal Cancer at MD Anderson Cancer Center
in Houston, Texas, and
co-investigator in the X-PECT trial stated, "The data from the
randomized Phase 2 trial continues to demonstrate the promising
activity of perifosine (an oral Akt pathway inhibitor) for
response, PFS, and OS in the care of previously treated, advanced
colorectal cancer. We look forward to collaborating in the
X-PECT trial."
Ron Bentsur, Chief Executive
Officer of Keryx, commented "We are pleased by the final data,
showing the promising activity of the perifosine + capecitabine
combination in this very advanced colorectal cancer patient
population. We believe that our Phase 3 study, in agreement
with the FDA under SPA, has been designed to confirm the activity
observed in this randomized Phase 2 trial."
A copy of the poster is available via request to
Keryx.
Perifosine is also currently in a Phase 3 trial, under
Special Protocol Assessment (SPA), for the treatment of
relapsed/refractory multiple myeloma.
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®), irinotecan
(Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®),
cetuximab (Erbitux®) , and panitumumab (Vectibix®). 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®, 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® or
Vectibix®. 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:
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Lauren
Fischer
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Director, Investor Relations
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Keryx Biopharmaceuticals, Inc.
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Tel: 212.531.5962
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E-mail: lfischer@keryx.com
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SOURCE Keryx Biopharmaceuticals, Inc.
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