"These data are encouraging and show that patients can be switched from a regimen of EPO three-times weekly to once monthly Hematide in a controlled fashion where hemoglobin levels were maintained within 1 g/dL of baseline at an appropriate dosing regimen," said Dr. Besarab. This is especially important given the growing concerns related to excessive hemoglobin increases due to erythropoiesis stimulating agent use."
"We believe these data support the once per month dosing of Hematide and warrant further investigation in pivotal clinical studies," added Anne-Marie Duliege, M.D., vice president, Clinical, Medical and Regulatory Affairs at Affymax. "Based on the entire Phase 2 data set and as a result of our end of Phase 2 meetings with the Food and Drug Administration (FDA), we are preparing for Phase 3 clinical trials in patients on dialysis and not on dialysis. We are currently in discussions with the FDA on the design of this Phase 3 program."
The Phase 2 trial, which involved 165 patients, was an open label, multi-dose study conducted to assess safety, pharmacodynamics and pharmacokinetics of Hematide in hemodialysis patients with stable baseline Hgb levels between 10 and 12.5 g/dL on previous Epoetin Alfa therapy. The endpoints were Hgb and reticulocyte levels, Hematide dose adjustments and red blood cell transfusions. In addition, adverse and serious adverse events were monitored.
Pharmacodynamic data were presented on the 90 patients who had completed six months of treatment. Mean reticulocyte increases were observed after every Hematide injection. The mean Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1 g/dL at the end of six months of treatment. In the 165 patients who received drug in this study, Hematide was generally well tolerated with an adverse event profile consistent with the hemodialysis patient population.
Hematide is a novel synthetic, pegylated peptide that binds to and activates the erythropoietin receptor. The product is being developed for treatment of anemia in chronic kidney disease and cancer.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company developing novel peptide-based drugs to improve the treatment of serious and often life-threatening conditions. Affymax's lead product candidate, Hematide(TM), is currently in Phase 2 clinical trials for the treatment of anemia associated with chronic kidney disease and cancer. 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, 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 deve lopment efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in the Company's Annual Report on Form 10-K 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.
Executive Director, Corporate Communications