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Affymax Doses First Patient in the Phase 3 Clinical Program
of Hematide™ to Treat Anemia in Chronic Renal Failure Patients
PALO ALTO, Calif. & OSAKA, Japan, Oct 11, 2007 (BUSINESS WIRE)
-- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company
Limited (TOKYO:4502) today announced that Affymax has dosed the
first patient in the Phase 3 clinical program of its lead
investigational therapy, Hematide™, for the treatment of anemia
in chronic renal failure patients.
"The initiation of our Phase 3 program for Hematide is a
significant milestone for Affymax, which positions us closer to
our ultimate goal of providing a convenient monthly treatment
alternative to the many patients suffering with anemia," said
Arlene M. Morris, president and chief executive officer of
Affymax. "We believe our program is uniquely designed to take
advantage of the most current regulatory and medical strategies
for the evaluation and use of erythropoiesis stimulating agents.
Hematide is a novel ESA with the potential to offer monthly
dosing to physicians and patients. Consistent with our previous
guidance, we anticipate all trials in the Phase 3 renal program
will begin enrolling patients by the end of the year with the
goal of completing enrollment in each of the trials in 2008. We
expect the submission of a New Drug Application for Hematide in
chronic renal failure in 2010 if all goes as planned."
"We are very excited with the initiation of the Phase 3 program
for Hematide," said Mr. Yasuchika Hasegawa, president of Takeda.
"Together with Affymax, we are conducting development activities
worldwide in both renal and oncology indications, and we are
looking forward to bringing this novel treatment option as soon
as possible to patients suffering with anemia."
The Hematide Phase 3 program, involving a total of approximately
2,200 chronic renal failure patients, consists of four
open-label, randomized controlled clinical trials in the U.S.
and Europe, including two trials in patients on dialysis and two
trials in patients not on dialysis. The trials in non-dialysis
patients, called PEARL 1 and PEARL 2, will evaluate the safety
and efficacy of Hematide compared to darbepoetin alfa in
correcting anemia and maintaining hemoglobin levels over time.
In dialysis patients previously-treated with EPO, the trials,
called EMERALD 1 and EMERALD 2, will evaluate the safety and
efficacy of Hematide and its ability to maintain hemoglobin
levels in a corrected range compared to epoetin alpha or epoetin
beta when patients are switched from either of these epoetins to
Hematide. Analysis of efficacy for each study will be based on
assessments of non-inferiority to the comparator drugs. The
primary efficacy endpoint will be the mean change in hemoglobin
from baseline. The hemoglobin target range will be 11-12 g/dL
for studies in non-dialysis patients and 10-12 g/dL for studies
in dialysis patients. In all studies, Hematide will be dosed
once every four weeks while comparator drugs will be dosed in
accordance with their respective product labels. Treatment in
each study will be continued until the last patient has been
treated for 52 weeks. Assessment of safety will include an
analysis of non-inferiority to comparator drugs using a
composite cardiovascular endpoint from a safety database pooled
from all four Phase 3 trials.
About Hematide
Hematide is a novel synthetic, pegylated peptidic compound that
binds to and activates the erythropoietin receptor and acts as
an erythropoiesis stimulating agent. The product is being
developed for treatment of anemia in patients with chronic renal
failure and cancer patients receiving chemotherapy.
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 being evaluated in Phase 3 clinical
trials for the treatment of anemia associated with chronic renal
failure and is in clinical trials for the treatment of
chemotherapy-induced 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.
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
Source
Affymax, Inc.
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