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Affymax® Reports Phase 2 Clinical
Trial Data Supporting Hemoglobin Increases with Once-Per-Month Hematide™ Regardless of Patient
Baseline Renal Function
PALO ALTO, Calif., May 26, 2009 (BUSINESS WIRE) -- Affymax, Inc.
(Nasdaq:AFFY) today announced data from a post hoc analysis of
120 patients in a Phase 2 clinical trial of Hematide™ in
non-dialysis chronic kidney disease (CKD) patients. The data
suggest that there is no major impact of baseline renal function
as measured by Estimated Glomerular Filtration Rate (eGFR)on the
monthly Hematide dose required to increase and maintain
hemoglobin (Hgb) values within target range in non-dialysis CKD
patients. The data were presented by Iain C. Macdougall, M.D. at
the World Congress of Nephrology meeting being held in Milan,
Italy.
"As Hematide is partially excreted by the kidneys, it was
imperative to evaluate whether renal function affected the
product's ability to achieve hemoglobin target ranges," said Dr.
Macdougall, consultant nephrologist in the Department of Renal
Medicine at King's College Hospital in London. "These data
suggest that Hematide results in appropriate management of
hemoglobin levels in a broad spectrum of patients with CKD,
regardless of baseline renal function. Anemia is a pervasive
problem in the chronic kidney disease patient population. Being
able to manage and control anemia allows treating physicians to
focus attention on management of the patient's underlying renal
disease."
The post-hoc analysis included data from an open-label Phase 2
study of 120 patients with stage 3, 4 or 5 CKD. The analysis
suggests that mean Hgb increased approximately 2 g/dL by three
months (from approximately 10 g/dL to approximately 12 g/dL) and
remained stable for five months across all CKD groups,
regardless of baseline eGFR. In addition, Hematide doses were
similar across all CKD groups regardless of baseline eGFR.
Twelve patients (10%) reported an adverse event considered
possibly related to treatment. Adverse events occurring in more
than one patient included arthritis (2), headache (2), and
hypertension (7). One serious adverse event, an embolic cerebral
infarction, was considered possibly related to study drug. The
study was not specifically designed to evaluate the effect of
renal function on Hematide dose and therefore caution should be
exercised in the interpretation of results.
Anne-Marie Duliege, M.D., chief medical officer for Affymax
added, "This is an encouraging post hoc analysis that warrants
further evaluation. Hematide's ability to increase hemoglobin in
a broad spectrum of chronic renal failure patients is the
subject of our ongoing Phase 3 clinical trials. We will continue
to generate data which we believe will assist physicians in
optimizing anemia management in their patients."
About Hematide
Hematide is a synthetic, peptidic erythropoiesis stimulating
agent (ESA) linked to polyethylene glycol (PEG) that is being
developed for the treatment of anemia associated with chronic
renal failure.
Affymax and Takeda are collaborating on the development of
Hematide and plan to co-commercialize the product in the United
States. The product, upon approval, will be commercialized in
the European Union by Takeda. Affymax is conducting Phase 3
clinical trials for Hematide to treat anemia associated with
chronic renal failure.
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.
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 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,
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.
Source
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Executive Director, Corporate Communications
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