Keryx Biopharmaceuticals' KRX-0401 (Perifosine) Data Selected for Oral Presentation at the 50th Annual Meeting of the American S
November 10 2008 - 9:28AM
PR Newswire (US)
Paul Richardson, MD to present results from Phase 1/2 Clinical
Trial of Perifosine in combination with Bortezomib (+/-
dexamethasone) on Tuesday, December 9, 2008 at 8:30am NEW YORK,
Nov. 10 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc.
(NASDAQ:KERX) today announced that data from its Phase 1/2 clinical
trial of KRX-0401 (perifosine) has been selected for oral
presentation at the upcoming 50th Annual Meeting of the American
Society of Hematology (ASH), to be held in San Francisco from
December 5-9, 2008. The study entitled "Phase I/II Results of a
Multicenter Trial of Perifosine (KRX-0401) + Bortezomib in Patients
with Relapsed or Relapsed / Refractory Multiple Myeloma Who Were
Previously Relapsed from or Refractory to Bortezomib," will be
presented on Tuesday, December 9th at 8:30 am PST by Paul
Richardson, M.D., Clinical Director of the Jerome Lipper Multiple
Myeloma Center at the Dana-Farber Cancer Institute in Boston, MA.
This abstract became available for viewing earlier today on the
American Society of Hematology website
(http://www.hematology.org/). There were 76 patients enrolled on
study at the time of abstract submission, of which 57 were
evaluable for response and are reported on within the abstract. An
updated analysis will be presented at the conference. As detailed
in the abstract, an overall response rate of 40% was seen in
evaluable patients. A similar level of activity was seen in the
subset of patients who were bortezomib-refractory. In the study,
overall response rate is defined to include all MRs, PRs and CRs.
Paul Richardson, MD commented, "The addition of perifosine to
bortezomib, with or without dexamethasone, has proved generally
well tolerated and continues to demonstrate encouraging activity
with an impressive overall response rate and promising time to
progression in these heavily pretreated, relapsed and refractory
patients." In addition to the KRX-0401 abstract which was selected
for oral presentation, four abstracts on KRX-0401 were accepted for
poster presentation. All of the clinical data to be presented
demonstrates the potential efficacy of KRX-0401, both as a single
agent and in combination with other approved agents, in the
treatment of patients with multiple myeloma and waldenstrom's
macroglobulinemia. "We are encouraged by the safety and efficacy
results obtained to date on the combination of KRX-0401 and
bortezomib in relapsed and refractory multiple myeloma patients who
were all previously treated with bortezomib," said Michael S.
Weiss, Chairman and Chief Executive Officer of Keryx
Biopharmaceuticals, Inc., who continued "we plan to further
evaluate the potential efficacy of KRX-0401 as a treatment for
multiple myeloma and related disorders and continue to explore the
design of a phase 3 program in multiple myeloma." Summary of
KRX-0401 Data Presentations ORAL PRESENTATION: TUESDAY, DECEMBER
9th Abstract 870 Title: Phase I/II Results of a Multicenter Trial
of Perifosine (KRX-0401) + Bortezomib in Patients with Relapsed or
Relapsed / Refractory Multiple Myeloma Who Were Previously Relapsed
from or Refractory to Bortezomib Session Name: Novel Therapies for
Myeloma and Related Disorders Session (7:00- 9:00 AM) Presentation
Time: 8:30am Location: Gateway Ballroom 103 - South Clinical Poster
Presentations: SATURDAY, DECEMBER 6th Abstract 1010 TITLE: Final
Results of a Phase II Trial of the Novel Oral Akt Inhibitor
Perifosine in Relapsed and/or Refractory Waldenstrom
Macroglobulinemia (WM) Session Name: Biologic Therapies for NHL
(Excluding Pre-clinical Models) Presentation Time: 5:30 PM - 7:30
PM Location: Moscone Center, Hall A Poster Board no.: I-115 MONDAY,
DECEMBER 8th Abstract 3691 TITLE: Phase I Results of Perifosine
(KRX-0401) in Combination with Lenalidomide and Dexamethasone in
Patients with Relapsed or Refractory Multiple Myeloma (MM) Session
Name: Myeloma - Therapy, excluding Transplantation Poster III
Presentation Time: 5:30 PM - 7:30 PM Location: Moscone Center, Hall
A Poster Board no.: III-773 Pre-Clinical Poster Presentations:
MONDAY, DECEMBER 8th Abstract 3663 TITLE: Combination of
Nab-Rapamycin and Perifosine Induces Synergistic Cytotoxicity and
Antitumor Activity Via Autophagy and Apoptosis in Multiple Myeloma
(MM) Session Name: Myeloma - Pathophysiology / Preclinical Studies
excluding Therapy Poster III Presentation Time: 5:30 PM - 7:30 PM
Location: Moscone Center, Hall A Poster Board no.: III-745 Abstract
1555 TITLE: Phenotypic and Functional Effects of Novel Akt
Inhibitor Perifosine on Immune System Session Name: Lymphocytes and
Lymphocyte Activation Poster I Presentation Time: 5:30 PM - 7:30 PM
Location: Moscone Center, Hall A Poster Board no.: I-660 Copies of
the above referenced abstracts can be viewed online through the ASH
website, http://www.hematology.org/. KRX-0401 (Perifosine)
Mechanism of Action and Profile 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, the 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 in patients with soft-tissue sarcoma, gastric,
hepatocellular, endometrial, prostate, renal cell, head and neck
cancers and hematological malignancies, 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. High pAkt is often seen in tumors that are
resistant to conventional cancer treatments, including
radiotherapy, chemotherapy, endocrine therapy, and especially
therapy with some of the newer biologicals. To date, over 1,700
patients have been treated with KRX-0401 in trials conducted both
in the United States and Europe. Its safety profile is distinctly
different from that of most cytotoxic agents. It does not appear to
cause myelosuppression (depression of the immune system that may
lead to life threatening infections), thrombocytopenia (a decrease
in platelets that may result in bleeding), skin rash, flu-like
symptoms or alopecia (hair loss); all of these toxicities occur
frequently with many of the currently available treatments for
cancer. The main side effects of perifosine are nausea, vomiting,
diarrhea and fatigue, but these are either mild or non-existent in
lower doses that have induced tumor regression. Responses have been
seen with both daily and weekly regimens. At the doses studied, the
daily regimens were better tolerated. In Phase 1/2 trials, KRX-0401
has induced tumor regressions and/or caused disease stabilization
in a variety of tumor types. KRX-0401 has shown single agent
partial responses in renal cell and hepatocellular carcinoma, soft
tissue sarcoma, GIST tumors, mesothelioma, and carcinoma of the
appendix. There is also evidence of activity in hematological
malignancies, especially multiple myeloma. Disease stabilization,
defined as time on treatment without progression for at least 6
months has been seen in 20 tumor types, including metastatic renal
cell cancer, hepatocellular carcinoma, melanoma, carcinoid,
prostate, head and neck, breast, and small cell lung cancer.
Responding patients, including stable disease, have been treated
for various durations up to more than three years. 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 Zerenex(TM) (ferric citrate), an oral,
iron-based compound that has the capacity to bind to phosphate and
form non-absorbable complexes. Zerenex 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 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, +1-212-531-5965, , Director, Investor Relations, Keryx
Biopharmaceuticals, Inc. Web Site: http://www.hematology.org/
http://www.keryx.com/
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