Affymax Initiates Clinical Trial of Hematide(TM) to Evaluate Correction of Anemia in Chronic Renal Failure Patients on Dialysis
Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has begun in a Phase 2 clinical trial of Hematide(TM) to correct anemia in patients with chronic renal failure (CRF) who are undergoing dialysis and are not actively being treated with an erythropoiesis stimulating agent (ESA). The trial is intended to generate data for Hematide as an anemia correction therapy in this segment of the CRF patient population, some of whom may be ESA-naive. This is the first Hematide correction study in the dialysis indication.
“We plan to have these data available to guide physicians on how to initiate dosing to correct anemia in dialysis patients,” said Arlene M. Morris, president and chief executive officer of Affymax, Inc. “Because anemia management is so prevalent and widely practiced before patients go onto dialysis in the United States and Western Europe, this trial is being conducted in Russia where a sufficient number of dialysis patients, not currently undergoing anemia therapy, can be enrolled. Our previous Phase 2 trials, as well as our ongoing Phase 3 trials, in dialysis patients were designed to evaluate Hematide in patients previously treated with an ESA by switching them to Hematide. This new study is one of several Phase 2 trials we plan to conduct to evaluate key differentiating attributes and to investigate the versatility of Hematide prior to commercialization, as we pursue our ultimate goal of broad use of the product globally.”
The Phase 2 clinical trial is a randomized, controlled study that is expected to enroll approximately 120 hemodialysis patients who have not had treatment with an ESA in a prior 12 week period. The primary objective of the trial is to evaluate the safety, efficacy and dose response to Hematide administered once per month. Enrollment in this trial is expected to be completed by year end.
Concurrently, the company is conducting a Phase 3 program for Hematide which will involve a total of approximately 2,400 chronic renal failure patients. This 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 a corrected range when patients are switched from epoetin alfa or epoetin beta to Hematide.
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. 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 and treatment 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.