Affymax Reports Phase 2 Sub-Analysis of Hematide in Hemodialysis Patients
-- Phase 2 Findings Presented at the National Kidney Foundation 2009 Spring Meeting --
NASHVILLE, Tenn.--(BUSINESS WIRE)--Mar 27, 2009 - Affymax, Inc. (Nasdaq:AFFY) today announced data from a post hoc sub-analysis of the Phase 2 clinical trial evaluation of Hematide in chronic renal failure patients undergoing dialysis. These data suggest that Hematide maintains stable hemoglobin levels in hemodialysis patients for up to two years regardless of baseline iron (ferritin and transferrin saturation [TSAT]) or C-reactive protein (CRP) status, key factors in anemia of chronic kidney disease that often impact responsiveness to therapy with erythropoiesis stimulating agents (ESAs).
Pablo Pergola, M.D., Ph.D. of Renal Associates in San Antonio Texas is the lead author of the poster, which was presented at the National Kidney Foundation 2009 Spring Clinical Meeting.
“These are encouraging data that show the ability of Hematide, dosed monthly, to maintain steady hemoglobin levels regardless of baseline ferritin, TSAT, or CRP,” said Dr. Pergola. “CRP levels are a key biomarker of inflammation. Patients on dialysis often present with various inflammation-related disorders, such as infections, vascular access issues, or atherosclerosis. Elevated CRP levels in this population are therefore common and often associated with increased ESA dose requirements. While patients in this study were iron-replete at entry, iron deficiency is a key underlying cause of poor ESA response in dialysis patients, many of whom have elevated ferritin levels. Having an ESA that can successfully maintain patients' hemoglobin levels within target in the large segment of the dialysis population who have a heavy disease burden and are often poorly responsive to ESAs would be a major advance for these patients.”
About the Phase 2 Study
Although no formal conclusions can be drawn from this sub-analysis, the data involves 100 dialysis patients enrolled in two ongoing long-term Phase 2 trials. Patients were originally enrolled in open-label studies to evaluate efficacy of Hematide in maintaining hemoglobin (Hb) levels within target in patients who switched from epoetin alfa to Hematide. Later, they were rolled over into a long-term maintenance study evaluating the safety and efficacy of Hematide. The patients received intravenous Hematide once every four weeks for approximately 24 months (6 months in the initial trial and 18 months in the maintenance study), totaling 24 doses. Dosing was designed to maintain Hb between 10–12.0 g/dL after protocol amendment in 2007 (2006 protocol targeted 11-13g/dL). Relevant inclusion criteria included serum ferritin greater than or equal to 100 ng/mL, TSAT greater than or equal to 20 percent (patients were iron-replete on entry), and CRP less than or equal to 30 mg/L. Iron status was maintained per K/DOQI and European Best Practices guidelines.
CRP is a protein found in the blood which, when elevated, is an indication of inflammation. High CRP (greater than 5 mg/L) may be associated with poor response to ESAs. Half of the patients in this sub-analysis had elevated baseline CRP levels. Yet in these patients, Hb was maintained at a mean of 11.6 g/dL within the target range based on the trial protocol. Similarly, Hb was maintained within the range in patients with varying ferritin and TSAT, two indicators of iron status.
Generally, Hematide was well-tolerated. Seven patients, or 7 percent, experienced adverse events assessed as possibly related to Hematide. Other adverse events were assessed as not related to study drug. Nineteen patients received at least one transfusion during the study.
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. 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 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.
Contact: Affymax, Inc.
Sylvia Wheeler, 650-812-8700
Executive Director, Corporate Communications
Posted: March 2009