Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Relapsed/Refractory Multiple Myeloma
02 Dezembro 2009 - 11:30AM
PR Newswire (US)
NEW YORK, Dec. 2 /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
the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment
of relapsed/refractory multiple myeloma. 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 Phase 3 trial investigating perifosine in combination
with bortezomib (VELCADE®) and dexamethasone for the treatment of
patients with relapsed/refractory multiple myeloma is expected to
commence by year-end under a Special Protocol Assessment (SPA) with
the FDA. In addition, in September, the Company announced that
perifosine had received Orphan-Drug designation in the United
States for the treatment of multiple myeloma. Ron Bentsur, Chief
Executive Officer of Keryx Biopharmaceuticals, commented, "This
Fast Track designation can significantly reduce the FDA review time
of a new drug application, and therefore can expedite the time to
market for perifosine in multiple myeloma." Mr. Bentsur added, "We
believe that the Fast Track designation, together with the SPA and
Orphan Drug status previously granted to us by the FDA for
perifosine in multiple myeloma, significantly enhances the value
proposition of perifosine in this indication. We are eager to begin
the Phase 3 trial later this month." 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 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, 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. About Multiple Myeloma Multiple myeloma, a cancer of the
plasma cell, is an incurable but treatable disease. Multiple
myeloma is the second most-common hematologic cancer, representing
1% of all cancer diagnoses and 2% of all cancer deaths. According
to the American Cancer Society, in 2009 there will be an estimated
20,580 new cases of multiple myeloma and an estimated 10,500 deaths
from multiple myeloma in the United States. To date, several FDA
approved therapies exist for the treatment of multiple myeloma.
Despite this progress, patients continue to relapse, become
refractory to prior treatments and eventually die from their
disease. Thus, new therapies are needed to treat these patients and
extend their survival. 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 the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key
signaling cascade that has been shown to induce cell growth and
cell transformation. 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 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, with a Phase 3 in multiple myeloma, under Special
Protocol Assessment (SPA), pending commencement by year-end. 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. Zerenex has recently completed a
Phase 2 clinical program as a treatment for hyperphosphatemia
(elevated phosphate levels) in patients with end-stage renal
disease, and Keryx is in the process of finalizing the U.S. Phase 3
program for Zerenex in consultation 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, 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 trial
will not coincide with the data analyses from the Phase 1 / 2
clinical trial 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: Lauren Fischer
Director, Investor Relations Keryx Biopharmaceuticals, Inc. Tel:
212.531.5962 E-mail: DATASOURCE: Keryx Biopharmaceuticals, Inc.
CONTACT: Lauren Fischer, Director, Investor Relations, Keryx
Biopharmaceuticals, Inc., +1-212-531-5962, Web Site:
http://www.keryx.com/
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