Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) t
December 07 2007 - 9:24AM
PR Newswire (US)
Data on Perifosine in the Treatment of Patients with
Relapsed/Refractory Multiple Myeloma to be presented on Saturday,
December 8th at 5:30pm NEW YORK, Dec. 7 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that
abstracts related to KRX-0401 (Perifosine) have been selected for
presentation during the poster sessions scheduled to take place at
the upcoming American Society Hematology Meeting and exposition
taking place at the Georgia World Congress Center in Atlanta,
Georgia (December 8-11, 2007). Copies of these abstracts, which
highlight the observed clinical activity of KRX-0401 in the
treatment of patients with relapsed/refractory multiple myeloma are
currently available and can be viewed on-line through the ASH
website: http://www.abstracts2view.com/hem07/ The following
abstracts will be presented on Saturday, December 8, 2007 at
5:30pm: [1164] - Board #318-I Multi-Center Phase II Study of
Perifosine (KRX-0401) Alone and in Combination with Dexamethasone
(dex) for Patients with Relapsed or Relapsed/Refractory Multiple
Myeloma (MM): Promising Activity as Combination Therapy with
Manageable Toxicity. Paul Richardson, S. Lonial, A. Jakubowiak, A.
Krishnan, J. Wolf, J. Densmore, S. Singhal, I. Ghobrial, J.
Stephenson, J. Mehta, K. Colson, D. Francis, T. Kendall, N.
Obadike, K. Sullivan, J. Martin, T. Hideshima, L. Lai, P.
Sportelli, L. Gardner, R. Birch, I.C. Henderson, K. Anderson [1169]
- Board #323-I A Multiple Myeloma Research Consortium (MMRC)
Multicenter Phase I Trial of Perifosine (KRX-0401) in Combination
with Lenalidomide and Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma (MM): Updated Results. Andrzej
Jakubowiak, Todd Zimmerman, Melissa Alsina, Paul Richardson,
Jonathan Kaufman, T. Kendall, C. Brozo, A. McAllister, C. Leister,
T. Hideshima, P. Sportelli, L. Gardner, R. Birch, I.C. Henderson,
K. Giusti, Kenneth Anderson [1170*] - Board #324-I Phase I/II
Report from a Multicenter Trial of Perifosine (KRX-0401) +
Bortezomib in Patients with Relapsed or Relapsed/Refractory
Multiple Myeloma Previously Treated with Bortezomib. Paul
Richardson, A. Jakubowiak, J. Wolf, J. Allerton, J. Zonder, S.
Lonial, A. Krishnan, J. Densmore, I. Ghobrial, K. Colson, T.
Kendall, C. Leister, B. Martineau, T. Hideshima, T. Facon, P.
Sportelli, L. Gardner, R. Birch, I.C. Henderson, K. Anderson * Data
reflected in Abstract 1170 is updated on Poster Board #324-1
Perifosine (KRX-0401) Mechanism of Action and Profile Perifosine
has been shown to inhibit or otherwise modify signaling through a
number of different signal transduction pathways including Akt,
MAPK, and JNK. Akt isoforms have been found to be overexpressed in
renal, breast, prostate, and pancreatic cancers. Elevated levels of
pAkt have been correlated with poor prognosis in patients with
gastric, hepatocellular, endometrial, prostate, renal cell and head
and neck cancers, as well as glioblastoma. The majority of tumors
expressing high levels of pAkt were high-grade, advanced stage or
had other features associated with poor prognosis. The effects of
perifosine on Akt are of particular interest because of 1) the
importance of this pathway in the development of most cancers; 2)
the evidence that it is often activated in tumors that are
resistant to other forms of anticancer therapy; and 3) and the
difficulty encountered thus far in the discovery of drugs that will
inhibit this pathway without causing excessive toxicity. To date,
over 1,500 patients have been treated with perifosine in trials
conducted both in the US and Europe. Its safety profile is
distinctly different from that of most cytotoxic agents. It does
not cause myelosuppression (depression of the immune system) or
alopecia (hair loss) like many currently available treatments for
cancer. In phase I/II trials it has induced tumor regressions
and/or caused disease stabilization in a variety of tumor types.
Responding patients, including stable disease, have been treated
for months to almost 3 years, on both the daily and weekly
schedule. 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, Inc. is focused on the acquisition,
development and commercialization of medically important, novel
pharmaceutical products for the treatment of life-threatening
diseases, including diabetes and cancer. Keryx's lead compound
under development is Sulonex(TM) (sulodexide oral gelcap),
previously referred to as KRX-101, a first-in-class, oral
heparinoid compound for the treatment of diabetic nephropathy, a
life-threatening kidney disease caused by diabetes. Sulonex is in a
pivotal Phase 3 and Phase 4 clinical program under a Special
Protocol Assessment with the Food & Drug Administration.
Additionally, Keryx is developing Zerenex(TM), an oral, iron- based
compound that has the capacity to bind phosphate and form
non-absorbable complexes. Zerenex is currently in Phase 2 clinical
development for the treatment of hyperphosphatemia (elevated serum
phosphorous levels) in patients with end-stage renal disease. Keryx
is also developing clinical-stage oncology compounds, including
KRX-0401, a novel, first-in-class, oral anti-cancer agent that
modulates Akt, a protein in the body associated with tumor survival
and growth, and 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. Keryx also has an active
in-licensing and acquisition program designed to identify and
acquire additional drug candidates. Keryx is headquartered in New
York City. Cautionary Statement Some of the statements included in
this press release, particularly those anticipating future the
financial performance and clinical 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 complete
the Phase 1 and Phase 2 clinical trials for KRX-0401; we may not be
able 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 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 of Investor Relations of Keryx Biopharmaceuticals, Inc.,
+1-212-531-5965, Web site: http://www.keryx.com/
http://www.abstracts2view.com/hem07
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