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Affymax Provides Phase 3 Program Update
for Investigational Drug, Hematide™, to Treat Anemia in Chronic
Renal Failure
All Four Pivotal Trials Tracking Toward Year-End 2009
Completion, Topline Results Now Likely in Q2 2010
PALO ALTO, Calif., Sep 09, 2009 (BUSINESS WIRE) -- Affymax, Inc.
(Nasdaq:AFFY) today announced that it has notified clinical
trial sites to complete treatment of patients in the Phase 3
clinical program for the investigational drug, Hematide, by the
end of 2009. The company expects a period of approximately four
months for data gathering and analysis, prior to reporting
topline results in the second quarter of 2010. This amended
timeline is not expected to affect the timing for New Drug
Application (NDA) submission. The Phase 3 clinical program
involves approximately 2,600 chronic renal failure patients at
more than 400 clinical trial sites.
"While some additional patient follow-up will extend our time to
study completion, we believe these collected data will further
strengthen and support our statistical plan," said Arlene
Morris, president and chief executive officer of Affymax, Inc.
"However, consistent with our previous guidance, we still expect
to submit an NDA for Hematide in chronic renal failure in 2010
if all goes as planned."
The Hematide Phase 3 program 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, are evaluating the safety and
efficacy of Hematide compared to darbepoetin alfa in correcting
anemia and maintaining hemoglobin levels over time.
In dialysis patients, the trials, called EMERALD 1 and EMERALD
2, are evaluating the safety and efficacy of Hematide and its
ability to maintain hemoglobin levels in the target range when
patients are switched from epoetin alfa or epoetin beta to
Hematide.
Analysis of efficacy for each study is based on assessments of
non-inferiority to the comparator drugs. The primary efficacy
endpoint is the mean change in hemoglobin from baseline. The
hemoglobin target range is 11-12 g/dL for studies in nondialysis
patients and 10-12 g/dL for studies in dialysis patients. In all
studies, Hematide is dosed once every four weeks while
comparator drugs are dosed more frequently in accordance with
their respective product labels. Treatment in each study is
planned until the last patient has been in the study for
approximately 52 weeks. The primary assessment of safety will be
an analysis of non-inferiority to comparator drugs using a
composite cardiovascular endpoint from a safety database pooled
from all four Phase 3 trials. The duration of the Phase 3 trials
depends on a sufficient number of cardiovascular safety events
for statistical analysis.
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 (ESA). Affymax and Takeda
Pharmaceutical Company Limited are collaborating on the
development of Hematide and plan to cocommercialize the product
once approved in the United States. Phase 3 clinical trials are
being conducted to investigate the potential for Hematide to
treat anemia associated with chronic renal failure.
About Anemia in Chronic Renal Failure (CRF)
Anemia in CRF affects many individuals with Chronic Kidney
Disease (CKD). According to the National Kidney Foundation, 26
million Americans - 1 in 9 U.S. adults - have CKD. Anemia
develops in the early stages of CKD and worsens as patients
progress towards total kidney failure and need a dialysis
machine to eliminate waste and water from their blood. In severe
or prolonged cases of anemia, the lack of oxygen in the blood
can cause serious and sometimes fatal damage to the heart and
other organs. Benefits of anemia correction in patients with CKD
include decreased morbidity, hospitalization, and mortality.1
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company committed to
developing novel drugs to improve the treatment of serious and
often life-threatening conditions. For additional information,
please visit
www.affymax.com.
This release contains forward-looking statements, including
statements regarding the success of the collaboration, 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 forwardlooking
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
and room temperature stability, the cardiovascular event rate in
our Phase 3 program, the timing of patient accrual in ongoing
and planned clinical studies, regulatory requirements and
approvals, research and development efforts, industry and
competitive environment, intellectual property rights and
disputes and other matters that are described in Affymax'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. 1.
http://www.anemia.org/pdf/mon_Anemia_and_CKD.pdf
Source
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Executive Director, Corporate Communications
Copyright Business Wire 2009
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