Phase 2 Affymax’s Hematide Study Enrolls Patients

Affymax Inc. started its Phase 2 clinical trials to study whether its drug Hematide can cure anemia in the patients on dialysis or not. According to Affymax,  study is conducted to collect the data  for the use of Hematide as anemia correction therapy in the patients suffering from Complete Renal Failure.

President and CEO of Affymax, Arlene M. Morris said, “We plan to have these data available to guide physicians on how to initiate dosing to correct anemia in dialysis patients.”

According to Affymax, the Phase 2 trial is a controlled study enrolling about 120 patients on hemodialysis. These patients have not undergone treatment with ESA. This trial evaluates the safety, dose and efficacy in response to the hematide administered once a month.

The Phase 3 trial for Hematide involves approximately 2400 patients suffering from chronic renal failure. This trial includes four open label, controlled clinical trials conducted in the United States and Western Europe. In this part of program, two trials will be conducted on the patients on hemodialysis and remaining two trials will be conducted on the patients not on dialysis.

The clinical trials on non-dialysis patients are called Pearl 1 and Pearl 2. These trials evaluate the efficacy and safety of Hematide as compared to darbepoetin alfa used for maintaining hemoglobin levels.  In dialysis patients, these trials are called Emerald 1 and Emerald 2 .