NEW YORK, April 8 /PRNewswire-FirstCall/ -- Keryx
Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the
initiation of a Phase 3 registration clinical trial for KRX-0401
(perifosine), the Company's novel, potentially first-in-class, oral
anti-cancer agent that inhibits Akt activation in the
phosphoinositide 3-kinase (PI3K) pathway, for the treatment of
patients with refractory advanced colorectal cancer.
The Phase 3 trial, entitled the "X-PECT"
(Xeloda® +
Perifosine Evaluation in
Colorectal cancer
Treatment) trial, is a randomized (1:1),
double-blind trial comparing the efficacy and safety of perifosine
+ capecitabine vs. placebo + capecitabine in approximately 430
patients with refractory advanced colorectal cancer. Patients must
have failed available therapy including 5-fluorouracil (5-FU),
oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab
(Avastin®) and, if KRAS wild-type, failed therapy with prior
cetuximab (Erbitux®) or panitumumab (Vectibix®). For
oxaliplatin-based therapy, failure of therapy will also include
patients who discontinued due to toxicity. The primary endpoint for
this study is overall survival, with secondary endpoints including
overall response rate, progression-free survival and safety. This
trial is being conducted pursuant to a Special Protocol Assessment
(SPA) with the Food and Drug Administration. Perifosine has
also been granted Fast Track designation for the treatment of
refractory advanced colorectal cancer.
Dr. Johanna Bendell, Director of
GI Oncology Research for the Sarah Cannon Research Institute,
Nashville, Tennessee, will lead
the Phase 3 investigational team that includes Dr. Cathy Eng, Associate Medical Director for the
Colorectal Center at MD Anderson Cancer Center in Houston, Texas.
Approximately 40 to 50 U.S. sites will participate in the study.
Enrollment is expected to take approximately 12 to 14 months, with
study completion expected in the second half of 2011.
Dr. Bendell stated, "We have now enrolled the first few patients
on the Phase 3 X-PECT trial, which provides an important clinical
trial option for patients with refractory advanced colorectal
cancer. The randomized Phase 2 data showed promising activity
of perifosine plus capecitabine compared to placebo plus
capecitabine. I believe the X-PECT trial will soon provide us
an answer as to the role of perifosine in the treatment of patients
with refractory colorectal cancer."
Ron Bentsur, CEO of Keryx
Biopharmaceuticals, commented: "Keryx is committed to
developing perifosine as a treatment that will provide meaningful
therapeutic value for patients living with refractory advanced
colorectal cancer. The Phase 2 trial conducted in this
setting provides strong rationale for the benefit of the
perifosine/capecitabine combination in the treatment of advanced
refractory colorectal cancer and we are extremely excited to
initiate this Phase 3 registration trial, pursuant to our SPA, with
the goal of potentially having the drug on the market for this
indication by mid-2012. We would like to thank Dr.
Bendell, Dr. Eng and the team of colorectal investigators for the
rapid initiation of this study and their invaluable guidance."
Perifosine is currently in a Phase 3 trial, under Special
Protocol Assessment (SPA), for the treatment of relapsed/refractory
multiple myeloma, with Orphan Drug Status and Fast Track
Designation granted.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna
Zentaris Inc. in the United
States, Canada and
Mexico.
PHASE 3 TRIAL DESIGN:
The Phase 3 X-PECT (Xeloda®
+ Perifosine
Evaluation in Colorectal
cancer Treatment) trial is a randomized
(1:1), double-blind trial comparing the efficacy and safety of
perifosine + capecitabine (capecitabine is a chemotherapy marketed
by Roche as Xeloda®) vs. placebo + capecitabine in approximately
430 patients with refractory advanced colorectal cancer. Patients
must have failed available therapy including 5-fluorouracil (5-FU),
oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab
(Avastin®) and, if KRAS wild-type, failed therapy with prior
cetuximab (Erbitux®) or panitumumab (Vectibix®). For
oxaliplatin-based therapy, failure of therapy will also include
patients who discontinued due to toxicity. The primary endpoint is
overall survival, with secondary endpoints including overall
response rate (complete + partial responses), progression-free
survival and safety. The median overall survival for the X-PECT
study's targeted patient population, that has failed prior
therapies as described above, is approximately 5 months. The X-PECT
study will be powered at 90% to detect a statistically significant
difference in overall survival, with an assumed median overall
survival for the control arm of 5-6 months and 7-8 months for the
perifosine arm. Approximately 360 events of death will trigger the
un-blinding of the study.
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 in patients with advanced
colorectal cancer. Currently, there are seven approved drugs for
patients with advanced 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. Bevacizumab, a VEGF monoclonal antibody, is
commonly administered with chemotherapy. Typically, patients who
fail 5-FU, oxaliplatin, irinotecan, and bevacizumab-containing
therapies, and who have wild-type KRAS status receive EGFR
monoclonal antibody therapy with either cetuximab or panitumumab.
Once patients progress on these agents, there are no further
standard treatment options.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by
which the FDA provides official evaluation and written guidance on
the design and size of proposed protocols that are intended to form
the basis for a new drug application.
Final marketing approval depends on the results of efficacy, the
adverse event profile and an evaluation of the benefit/risk of
treatment demonstrated in the Phase 3 trial. The SPA agreement may
only be changed through a written agreement between the sponsor and
the FDA, or if the FDA becomes aware of a substantial scientific
issue essential to product efficacy or safety. For more information
on Special Protocol Assessment, please visit:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
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 multiple myeloma and refractory advanced
colorectal cancer, and in Phase 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 pending commencement under 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 the Phase 3 trials will not coincide with the data
analyses from the Phase 1 and Phase 2 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 and the
FDA 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
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SOURCE Keryx Biopharmaceuticals, Inc.