Keryx Biopharmaceuticals Announces Poster Presentation Highlighting Clinical Activity of KRX-0401 (Perifosine) at the 51st Annua
11 Noviembre 2009 - 7:30AM
PR Newswire (US)
Updated Analyses of Phase 1/2 Clinical Trial of KRX-0401 in
Combination with Bortezomib (+/- Dexamethasone) to be Presented on
Saturday, December 5, 2009 NEW YORK, Nov. 11 /PRNewswire-FirstCall/
-- Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced
that data from its Phase 1/2 clinical trial of KRX-0401
(perifosine) in combination with bortezomib (+/- dexamethasone) has
been selected for poster presentation at the upcoming 51st Annual
Meeting of the American Society of Hematology (ASH), to be held in
New Orleans from December 5-8, 2009. The clinical data to be
presented demonstrates the potential safety and efficacy of
KRX-0401 in the treatment of patients with relapsed/refractory
multiple myeloma. Details on the Abstract selected for poster
presentation are as follows: Abstract #: 1869 TITLE: Perifosine in
Combination with Bortezomib and Dexamethasone Extends
Progression-Free Survival and Overall Survival in
Relapsed/Refractory Multiple Myeloma Patients Previously Treated
with Bortezomib: Updated Phase I/II Trial Results Lead Author: Paul
Richardson, MD Session Name: Myeloma - Therapy, excluding
Transplantation Poster I Date: Saturday, December 5, 2009
Presentation Time: 5:30 PM - 7:30 PM Location: Ernest N. Morial
Convention Center, Hall E Poster Board no.: I-891 This abstract
became available for viewing yesterday on the American Society of
Hematology website (http://www.hematology.org/). At the time of the
abstract submission in mid-August 2009, there were 84 patients
enrolled on study, of which 73 were evaluable for efficacy and are
reported on within the abstract. Updated efficacy (response rate,
time-to-progression and survival) and safety analyses, as of
mid-November 2009, will be presented at the conference. A copy of
the above referenced abstract can be viewed online through the ASH
website, http://www.hematology.org/. KRX-0401 (perifosine) is
in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS;
TSX: AEZ) in the United States, Canada and Mexico. 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 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 complete
clinical trials for KRX-0401; our ability to meet anticipated
development timelines for KRX-0401 due to recruitment, clinical
trial results, manufacturing capabilities or other factors; 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 intend 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 in our website and in the American Society of
Hematology's website is not incorporated by reference into this
press release and is included as an inactive textual reference
only. KERYX CONTACT: Lauren Fischer Director - Investor Relations
Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail:
DATASOURCE: Keryx Biopharmaceuticals, Inc. CONTACT: Lauren Fischer,
Director - Investor Relations, Keryx Biopharmaceuticals, Inc.,
+1-212-531-5965, Web Site: http://www.keryx.com/
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