NEW YORK, April 5 /PRNewswire-FirstCall/ -- Keryx
Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation 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 refractory advanced colorectal cancer.
The Fast Track program of the FDA is designed to facilitate the
development and expedite the review of new drugs that are intended
to treat serious or life-threatening conditions and that
demonstrate the potential to address unmet medical needs. Fast
Track designated drugs ordinarily qualify for priority review,
thereby expediting the FDA review process.
A randomized, double-blind Phase 3 trial investigating
perifosine in combination with capecitabine (Xeloda®) versus
placebo in combination with capecitabine in patients with
refractory advanced colorectal cancer is expected to commence in
the second quarter of 2010 under a Special Protocol Assessment
(SPA) with the FDA.
Ron Bentsur, Chief Executive
Officer of Keryx Biopharmaceuticals, commented, "We believe that
this Fast Track designation adds substantial value to perifosine's
development in refractory advanced colorectal cancer. We
intend to initiate the Phase 3 colorectal study in the second
quarter, with study completion expected in the second half of 2011.
With the SPA and Fast Track designation in place, we believe
that commercialization of perifosine in this indication could
potentially commence by mid-2012."
In addition to colorectal cancer, perifosine is currently in a
Phase 3 trial, under 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. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
About KRX-0401 (perifosine)
KRX-0401 (perifosine) is 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. The
effects of KRX-0401 on Akt are of particular interest because of
the importance of this pathway in the development of most cancers,
with 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. KRX-0401 has
demonstrated both safety and clinical efficacy in several tumor
types, both as a single agent and in combination with novel
therapies.
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
metastatic/advanced colorectal cancer. Currently, there are seven
approved drugs for patients with metastatic/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 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 a Phase 3 trial, under
Special Protocol Assessment (SPA), in multiple myeloma, with a
Phase 3 trial in refractory advanced colorectal cancer, under SPA,
pending commencement, and in Phase 2 clinical development for
several other tumor types. 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; the risk that fast track designation and
priority review may not result in earlier approval; 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.