AFFYMAX biotechnology is a spin-off of GlaxoSmithKline. The firm is developing a pipeline of synthetic peptide-based alternatives to protein drugs. To do so, it utilizes its Recombinant Peptide Diversity technique. Affymax' clinically validated therapeutic targets are kidney disease and cancer. Hematide, its lead product, is in late state clinical development. It is an erythropoietin (EPO) mimetic designed to stimulate red blood cell production as innate EPO does. Its chemical structure is unrelated to endogenous erythropoietin. Affymax believes Hematide will be cheaper and its effect will be of longer duration than the currently available EPO stimulants.

NEWS

4/23.07: Affymax, announced results from two separate Phase 2 clinical trials of Hematide™ in dialysis and non-dialysis chronic kidney disease (CKD) patients. The data showed that in treatment naive, non-dialysis patients Hematide could correct anemia when administered monthly at an appropriate dose. Similarly, the data in dialysis patients previously treated with three-times weekly Epoetin Alfa demonstrated that mean hemoglobin (Hgb) levels could be maintained at clinically acceptable levels following a switch to once monthly dosing of Hematide at an appropriate dose. The data were presented by Iain C. Macdougall, M.D. at the World Congress of Nephrology meeting being held in Rio de Janeiro.

"These data show that Hematide results in appropriate management of hemoglobin levels in a broad spectrum of patients with CKD from early-stage patients not on dialysis to patients with end-stage renal disease requiring continuous dialysis support," said Dr. Macdougall. "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."

At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 180 patients who had mostly completed six months of treatment at European and U.S. sites.

Of those, 90 treatment naive CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to greater than 11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patients previously treated with Epoetin Alfa were switched to Hematide once every four weeks. The mean baseline Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1 g/dL at the end of six months of treatment. Hematide was generally well tolerated with an adverse event profile consistent with the chronic kidney disease patient population.

Anne-Marie Duliege, M.D., vice president, Clinical, Medical and Regulatory Affairs for Affymax added, "As we prepare for Phase 3 clinical trials for Hematide, these data support our goal to evaluate the product in a broad CKD patient population. The Phase 3 studies will assess the safety and efficacy of Hematide in these patient populations and will generate sufficient clinical data to assist physicians in optimizing anemia management in their patients."

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.

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