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Affymax® Announces Phase 3
Development Plan for Hematide™
PALO ALTO, Calif., Jul 16, 2007 (BUSINESS WIRE) -- Affymax, Inc.
(Nasdaq:AFFY) today announced that it plans to initiate Phase 3
clinical studies with Hematide(TM) in chronic renal failure
patients following recent discussions with the United States
Food and Drug Administration (FDA) on the design of the Phase 3
clinical trial program. Hematide is the company's lead drug in
development for the treatment of anemia.
"Following meetings with the FDA, we believe we are well
positioned to take advantage of the most current thinking on the
evaluation and use of erythropoiesis stimulating agents," said
Arlene M. Morris, president and chief executive officer of
Affymax. "We look forward to beginning our Phase 3 program, with
enrollment expected to commence later this year. Once we begin
to enter patients into the program, we expect it will take
approximately 12 months to complete enrollment for the planned
Phase 3 studies."
The Phase 3 program will include four open-label, randomized
controlled clinical trials involving a total of approximately
2,200 chronic renal failure patients, including those on
dialysis and not on dialysis. Two trials in non-dialysis
patients are designed to evaluate the safety and efficacy of
Hematide compared to darbepoetin alfa in correcting anemia and
maintaining hemoglobin in a corrected range over time. In
dialysis patients previously-treated with EPO, two trials 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 and
safety for all studies 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 a composite cardiovascular
endpoint from a pooled safety database. The company expects to
submit a New Drug Application for Hematide in chronic renal
failure in 2010 if all goes as planned.
Teleconference/Webcast Details
Affymax will host a teleconference and webcast at 10:00 a.m.
Eastern time today to further discuss the Phase 3 development
plan and provide a company update. Interested parties can listen
to the live call by dialing (800) 810-0924 from the U.S. or
(913) 981-4900 internationally. There also will be a live and
archived webcast that can be accessed by visiting
www.affymax.com
and going to the Investors section. A telephone replay will be
available for seven days following the conclusion of the call by
dialing (888) 203-1112 from the U.S. or (719) 457-0820 for
international callers and entering passcode 2846279.
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 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 in Phase 3
clinical trial stage for the treatment of anemia associated with
chronic renal failure and in Phase 2 clinical trials for the
treatment of anemia in cancer patients. For additional
information, please visit
www.affymax.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.
Source
Affymax, Inc.
Sylvia Wheeler, 650-812-8700
Executive Director, Corporate Communications
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