Hematide™, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), is a product candidate that has demonstrated the ability to stimulate the production of red blood cells. If proven safe and effective in clinical trials, it may offer physicians and patients an alternative therapy to recombinant erythropoietin, a hormone that stimulates red blood cell formation.
Affymax is conducting a Phase 3 program for Hematide which 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 U.S. 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.
In addition, the company has a randomized, controlled Phase 2 clinical trial that is expected to enroll approximately 120 hemodialysis patients who have not had treatment with an ESA in a prior 12 week period. 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.
Hematide has several attributes that distinguish it from recombinant products. One differentiator is that it has a novel amino acid sequence that is unrelated to erythropoietin or to any other known naturally-occurring human sequences. Therefore, we believe it will not cause pure red cell aplasia, a hematological disorder that can be induced by treatment with recombinant erythropoietin.
Hematide’s properties may include monthly administration, relatively uncomplicated chemical synthesis, greater stability than currently marketed products, and room temperature storage.
ANEMIA
Anemia, a deficiency of red blood cells, is becoming increasingly prevalent in the United States. According to the National Kidney Foundation, 20 million Americans—1 in 9 U.S. adults—have chronic kidney disease (CKD). African Americans, Hispanics, Pacific Islanders, Native Americans, and seniors are at increased risk. Anemia is a frequent and serious complication associated with a number of increasingly common and severe diseases, including CKD, and cardiovascular disease. It can also occur in patients with other chronic diseases that cause inflammation, infection, or bleeding. CKD often leads to debilitating and life-threatening anemia.
ESAs have been used successfully to manage anemia in patients with CKD. ESA therapy has dramatically reduced the need for blood transfusions and the frequency and severity of anemia-associated morbidity, resulting in an improved quality of life for patients.
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