Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexam
February 26 2009 - 8:29AM
PR Newswire (US)
New subset analysis of bortezomib-relapsed patient population
demonstrates 55% overall response rate and extended time to
progression NEW YORK, Feb. 26 /PRNewswire-FirstCall/ -- Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced updated
clinical results from an ongoing Phase 1/2 study of KRX-0401
(perifosine) in combination with bortezomib (+/- dexamethasone) in
patients with relapsed/refractory multiple myeloma. The data, which
was presented earlier today in a poster featured at the 12th
International Multiple Myeloma Workshop in Washington, DC,
highlights a subset analysis of the bortezomib-relapsed patients
who were evaluable at the time of this report. Data from this Phase
1/2 study were previously presented in December 2008 at the
American Society of Hematology meeting via an oral presentation
entitled "A Multicenter Phase 1/2 Study Evaluating the Safety and
Efficacy of Perifosine (KRX-0401) + Bortezomib (VELCADE(R)) in
Patients with Relapsed or Relapsed / Refractory Multiple Myeloma
Who Were Previously Treated with Bortezomib." Updated results from
this fully enrolled study are as follows: Trial Summary:
Eighty-four patients were enrolled in a combined Phase 1/2 study
(18 patients in the Phase I component and 66 patients in the Phase
II component). At the time of this analysis, 73 patients were
evaluable for response. Median prior lines of therapy was 5 (range
1 - 13), including; 100% of patients had been treated with
bortezomib (50% of the patients were previously treated with at
least 2 bortezomib-based therapies and 81% were previously treated
with bortezomib plus dexamethasone); 98% of patients were
previously treated with dexamethasone; 99% of patients were
previously treated with lenalidomide (Revlimid(R)) and/or
thalidomide (Thalomid(R)); and 57% of patients had prior stem cell
transplant. No unexpected adverse events have been seen. Toxicities
were manageable with supportive care and/or dose reductions as
required. Best response (MR or better) and stable disease (no
progression for 3 months) to either perifosine + bortezomib
(+/-dexamethasone) for patients previously relapsed from or
refractory to prior bortezomib treatment was as follows: Evaluable
Patients CR PR MR ORR SD > 3 mos Bortezomib Relapsed (n=20) 2
10% 6 30% 3 15% 11 55% 9 45% Bortezomib Refractory (n=53) 1 2% 6
11% 10 19% 17 32% 24 45% All Evaluable Patients (n=73) 3 4% 12 16%
13 18% 28 38% 33 45% Patients who had previously relapsed on a
bortezomib-based treatment had a median time to progression (TTP)
of 8.5 months. The median TTP for all 73 evaluable study patients
(both bortezomib relapsed and refractory) was 6.4 months. As of the
report, 16 patients remain on active treatment. Commenting on the
data, Dr. Paul Richardson stated "Perifosine in combination with
bortezomib and dexamethasone continues to demonstrate an impressive
response rate and time to progression in a heavily pre-treated
patient population, with 83% of evaluable patients achieving stable
disease or better. Particularly noteworthy is the benefit observed
in patients who relapsed on prior bortezomib-based therapy, as
reflected by an 8.5 month median time to progression in our study.
We continue to be encouraged by the data and look forward to
evaluating this combination in a randomized phase 3 trial." Michael
S. Weiss, Chairman and CEO of Keryx Biopharmaceuticals, remarked,
"We believe these data confirm the activity of perifosine both in
patients who have relapsed following bortezomib therapy and in
those patients who were refractory to bortezomib. We continue to be
encouraged by the evolving data on the combination of perifosine
and bortezomib in patients with multiple myeloma." One additional
multiple myeloma clinical poster was presented as follows: Phase 1
Updated Results of Perifosine (KRX-0401) in Combination with
Lenalidomide and Dexamethasone in Patients with Relapsed or
Refractory Multiple Myeloma (MM) Perifosine in combination with
Revlimid(R) + dexamethasone continues to be well tolerated, with a
median progression-free survival in responding patients of 10.9
months. Median overall survival still has not been reached now at
17 months. Nine patients remain on active treatment. 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, novel pharmaceutical products for the
treatment of life-threatening diseases, including renal disease and
cancer. Keryx is developing Serene(TM) (ferric citrate), an oral,
iron-based compound that has the capacity to bind to phosphate and
form non-absorbable complexes. Serene is currently in Phase 2
clinical development for the treatment of hyperphosphatemia
(elevated phosphate levels) in patients with end-stage renal
disease. The Company is also developing KRX-0401 (perifosine), a
novel, potentially first-in-class, oral anti-cancer agent that
modulates Akt, a protein in the body associated with tumor survival
and growth. 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. The Company
also has an 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 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 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 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, or Web Site: http://www.keryx.com/
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