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Affymax® Announces Hematide™
Successfully Restores Hemoglobin in Patients with Pure Red Cell
Aplasia (PRCA)
-- Phase 2 Study Findings Presented at American Society of
Nephrology Renal Week 2007 --
PALO ALTO, Calif. & OSAKA, Japan, Nov 05, 2007 (BUSINESS WIRE)
-- Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical
Company Limited (TOKYO:4502) today announced results from a
Phase 2 clinical trial of Hematide™ to treat anemia in dialysis
and predialysis chronic kidney disease (CKD) patients with pure
red cell aplasia (PRCA, Anti-erythropoietin antibody-mediated).
Results showed that Hematide could restore hemoglobin to the
target range in these patients and eliminate the need for red
blood cell transfusions in the patients studied.
The data were presented yesterday by Iain C. Macdougall, M.D.,
Hematide clinical trial investigator, consultant nephrologist
and honorary senior lecturer at King's College Hospital in
London during an oral presentation at the American Society of
Nephrology Renal Week 2007 in San Francisco. In addition, Phase
2 clinical trial results of Hematide in patients with anemia due
to CKD were presented during the poster session.
PRCA, a rare autoimmune disorder, occurs when the body produces
neutralizing antibodies to the currently marketed recombinant
human erythropoietin (EPO), thus suppressing the production of
red blood cells by the bone marrow. In contrast, Hematide,
Affymax's lead drug in development for the treatment of anemia,
is a novel synthetic, pegylated peptidic compound with no
structural homology with human EPO.
"PRCA is a treatment complication resulting when a patient
develops antibodies to recombinant EPO products. While rare,
PRCA is a serious disease that prohibits further treatment with
recombinant EPO and requires patients undergo regular blood
transfusions and immunosuppressive therapy to suppress antibody
production in an attempt to correct anemia and manage hemoglobin
levels," said Dr. Macdougall, consultant nephrologist in the
Department of Renal Medicine at King's College Hospital in
London, U.K. "These trial results provide important information
about the safety profile of Hematide."
"Hematide is immunologically distinct from EPO. In preclinical
studies, Hematide addressed hemoglobin deficiencies caused by
EPO-specific antibodies, and antibodies generated to recombinant
EPO have not been shown to cross-react with Hematide," added
Robert B. Naso, Ph.D., executive vice president of research and
development at Affymax. "The PRCA data presented at ASN are
intriguing findings which support the differentiation of
Hematide. At some point in the future, Affymax and Takeda may
decide to pursue further development of the product in the area
of PRCA, but for now our development priorities are focused on
anemia in chronic renal failure and chemotherapy-induced
anemia."
"We are pleased with this data presentation, which suggests the
difference of Hematide," said Masaomi Miyamoto, Ph.D., general
manager of pharmaceutical development division at Takeda. "With
our partner Affymax, we will vigorously continue development
activities of this scientifically interesting product as a
potential new treatment option for patients with anemia in both
chronic renal failure and chemotherapy-induced anemia."
PRCA Study Results
The open-label, multi-center trial in 10 dialysis and
predialysis CKD patients with PRCA evaluated the effectiveness
and safety of Hematide administered subcutaneously every four
weeks. The primary endpoint was the change in hemoglobin from
baseline over time. Secondary endpoints included safety and the
effectiveness of Hematide in reducing the frequency of red blood
cell transfusions over time.
Results showed that by six months of treatment, median
hemoglobin had increased from 9.7 g/dL to 11.6 g/dL and
transfusion requirements were eliminated. Three patients, who
had their hemoglobin levels increased with Hematide, improved
sufficiently to undergo kidney transplant surgery. Hematide was
generally well tolerated. Some adverse events, including bone
pain, hypertension, injection site hematoma, and increased blood
pressure, were considered possibly related to Hematide.
Hematide Phase 2 Trial Results Also Presented at ASN
Conference
In addition to the oral presentation on PRCA trial results, two
posters from two separate Phase 2 clinical trials of Hematide in
dialysis and predialysis CKD patients were presented at the ASN
conference. These data showed that Hematide increased hemoglobin
in treatment-naive, predialysis patients when administered
monthly at an appropriate dose. Similarly, the data in dialysis
patients previously treated with three-times weekly Epoetin alfa
demonstrated that mean hemoglobin levels were maintained at
target levels following a switch to once-monthly dosing of
Hematide at an appropriate dose.
About Hematide
Hematide is a novel synthetic, pegylated peptidic compound that
binds to and activates the erythropoietin receptor and thus acts
as an erythropoiesis stimulating agent. The investigational
product is being evaluated in a Phase 3 program for the
treatment of anemia in patients with dialysis and predialysis
chronic renal failure (CRF) and earlier stage clinical trials in
cancer patients receiving chemotherapy.
About PRCA
Dialysis and non-dialysis patients with CKD frequently develop
anemia because of a reduction in native EPO production by
dysfunctional kidneys. Since the late 1980s, recombinant EPO has
been used successfully to treat anemia-associated EPO
deficiency. A small number of CKD patients develop
antibody-mediated PRCA, a type of anemia that develops when
patients mount a neutralizing antibody response to recombinant
EPO used to treat the anemia associated with CKD. These
antibodies neutralize not only the recombinant EPO but also
cross-neutralize natural EPO produced by the patients, leading
to a state of absolute EPO resistance and transfusion
dependence. While the incidence of PRCA has decreased, there
continues to be sporadic reports of antibody-mediated PRCA
associated with commercially available EPO products. Concern
over PRCA prompted the addition of warnings in the prescribing
information of all EPO-based products marketed in the U.S.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company developing novel
drugs to improve the treatment of serious and often
life-threatening conditions. Affymax's lead product candidate,
Hematide™, is currently in Phase 3 clinical trial stage for the
treatment of anemia associated with chronic renal failure and in
clinical trials for the treatment of anemia in cancer patients.
For additional information, please visit
www.affymax.com.
About Takeda
Located in Osaka, Japan, Takeda (TOKYO:4502) is a research-based
global company with its main focus on pharmaceuticals. As the
largest pharmaceutical company in Japan and one of the global
leaders of the industry, Takeda is committed to striving toward
better health for individuals and progress in medicine by
developing superior pharmaceutical products. Additional
information about Takeda is available through its corporate
website,
www.takeda.com.
This release contains forward-looking statements, including
statements regarding the timing, design and results of the
Company's clinical trials and drug development program and the
timing and likelihood of the commercialization of Hematide. The
Company's actual results may differ materially from those
indicated in these forward-looking statements due to risks and
uncertainties, including risks relating to the continued safety
and efficacy of Hematide in clinical development, the potential
for once per month dosing, regulatory requirements and
approvals, research and development efforts, industry and
competitive environment, intellectual property rights and
disputes and other matters that are described in the Company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only
as of the date of this release. The Company undertakes no
obligation to update any forward-looking statement in this press
release.
ASN Abstract #SU-FC061: Treatment of Erythropoietin
Antibody-Mediated Pure Red Cell Aplasia with a Novel Synthetic
Peptide-based Erythropoietin Receptor Agonist. Presented in an
oral session at the American Society of Nephrology Renal Week
2007, Sunday, November 4, 4:00-6:00 p.m.
ASN Abstract #SU-PO783: Comparison of Monthly Dosing Schemes
Using Hematide, a Synthetic Peptide-based Erythropoiesis
Stimulating Agent (ESA), to Maintain Hemoglobin (Hb) in
Hemodialysis (HD) Patients Previously Treated with Epoetin Alfa
(EPO). Presented in a poster presentation at the American
Society of Nephrology Renal Week 2007, Saturday, November 3,
11:00 a.m. - 12:00 p.m.
ASN Abstract #SA-PO777: Comparison of Monthly Dosing Schemes
Using Hematide, a Synthetic Peptide-based Erythropoiesis
Stimulating Agent (ESA), to Correct Anemia in Patients with
Chronic Kidney Disease (CKD) not on Dialysis. Presented in a
poster presentation at the American Society of Nephrology Renal
Week 2007, Sunday, November 4, 11:00 a.m. - 12:00 p.m.
Source
Affymax, Inc.
Contact
Affymax, Inc.
Sylvia Wheeler, 650-812-8700
Executive Director, Corporate Communications
or
Takeda Pharmaceutical Company Limited
Seizo Masuda, +81-3-3278-2037
Coordinator, Corporate Communications
Copyright Business Wire 2007
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