Affymax starts enrollment in Phase 2 Hematide study

PALO ALTO, Calif.—Affymax Inc. has started enrollment in to a Phase 2 clinical trial to study whether or not its drug Hematide can correct anemia in dialysis patients who are not being treated with an erythropoiesis stimulating agent.

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-naïve, according to Affymax. 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 CEO of Affymax. “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, according to Affymax. 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 that 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 United States 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.