PALO ALTO, Calif., Dec. 12 /PRNewswire/ -- Affymax, Inc., a clinical-stage pharmaceutical company, today announced interim results from a double-blind, placebo-controlled, dose-escalation, single-center Phase 2 clinical trial of Hematide(TM), a novel peptide-based drug candidate designed to stimulate the production of red blood cells and the Company's first product candidate to enter the clinic. Results from the first cohort of patients who received a single IV injection of Hematide at a dose of 0.05 mg/kg or placebo indicate that Hematide has potent and sustained erythropoietic activity (i.e., increases in red blood cell production) in patients with anemia due to chronic kidney disease (CKD) who are not on dialysis and have not previously been treated with erythropoietin. The data were presented in a poster session at the 47th Annual Meeting of the American Society of Hematology in Atlanta.
"The finding that increased hemoglobin levels are sustained for at least a month after a single injection of Hematide in CKD patients provides strong support for further study of monthly administration of Hematide to correct anemia and maintain hemoglobin in the target range," said Dr. Iain C. Macdougall, clinical trial investigator and consultant nephrologist in the Department of Renal Medicine at King's College Hospital in London. "There is a need for innovative erythropoiesis-stimulating agents such as Hematide to improve the management of anemia, and physicians would welcome new long-acting agents."
Phase 2 Study Results
After 28 days of follow up of patients in the first cohort, results showed that a single IV dose of 0.05 mg/kg Hematide is well tolerated. No study participants discontinued Hematide or withdrew from the study due to an adverse event, and no antibodies to Hematide were detected in the serum of study participants. In addition, a clinically significant increase in hemoglobin from baseline was observed and sustained for more than one month, with a maximum average increase of 1.27 g/dL compared to baseline. This response was similar to that observed in a study of normal healthy volunteers (1.36 g/dL) who received Hematide at twice the dose (0.1 mg/kg) given to patients with CKD. Six of seven CKD patients (86 percent) who received Hematide at a dose of 0.05 mg/kg had a hemoglobin increase >1 g/dL. Changes in other pharmacodynamic parameters (e.g., increased hematocrit and red blood cells) were consistent with stimulation of erythropoiesis.
"These findings are promising and provide support for additional studies of multiple doses of Hematide in patients with anemia related to CKD or cancer," said Anne-Marie Duliege, M.D., M.S., vice president of Clinical, Medical, and Regulatory Affairs for Affymax. "The fact that the response in CKD patients was similar to that observed in healthy volunteers who received twice the dose is consistent with the longer half-life observed in CKD patients and suggests that CKD patients may be more sensitive to Hematide than healthy volunteers."
About Hematide(TM)
Hematide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), has a completely novel amino acid sequence that is unrelated to erythropoietin, a hormone that stimulates red blood cell formation, or to any other known naturally-occurring human sequences. Hematide, which is designed to have several potential benefits, including simplified dosing characterized by monthly administration, uncomplicated chemical synthesis, low immunogenicity, and room temperature storage, is being developed to treat anemia.
Currently, Hematide is being studied in a Phase 2b open-label, repeat dose, dose-finding study in the U.S. in hemodialysis patients with end-stage renal disease, and separately in a Phase 2b multi-center, open-label, dose-finding trial in Europe in CKD patients who are not on dialysis and who have not been treated previously with erythropoietin. Affymax anticipates initiating a Phase 2 dose-finding trial of Hematide for treatment of anemia in cancer patients later this year.
About Anemia, Chronic Kidney Disease, End-Stage Renal Disease, and Treatment
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. 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 cancer, 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. Patients with CKD usually progress to ESRD, a condition in which kidney function is severely reduced or lacking. Progression to ESRD results in the need for renal dialysis, most often in the form of hemodialysis, a medical procedure that must be repeated as often as three times per week to remove toxic substances from the blood. Patients on renal dialysis therapy are anemic as a result of their disease and the dialysis treatment and they remain so unless treated with an ESA or blood transfusion.
ESAs have been used successfully to manage anemia in patients with chronic kidney disease and cancer-related anemia, constituting a $12 billion market worldwide. 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. Hematide represents a next-generation ESA that, if proven safe and effective in clinical trials, may improve the management of anemia and offer patients and physicians an alternative therapy.
About Affymax
Affymax, Inc. is a clinical-stage pharmaceutical company that is developing a rich pipeline of synthetic peptide-based drugs against clinically validated targets for the treatment of kidney diseases and cancer. Hematide(TM), the Company's first product candidate to enter the clinic, is a novel peptide-based drug designed to stimulate the production of red blood cells. It is in Phase 2 trials for the treatment of anemia associated with chronic kidney disease. For more information go to www.affymax.com.
ASH Abstract #3532. Hematide, a Synthetic Peptide-Based Erythropoiesis-Stimulating Agent (ESA), Demonstrates Erythropoietic Activity in a Phase 2 Single-Dose, Dose-Escalating Study in Patients with Chronic Kidney Disease (CKD). Presented at the 47th Annual Meeting of the American Society of Hematology, December, 12, 2005, Atlanta.
Affymax, Inc.CONTACT: Mary Fermi, Senior Director, Commercial Development of Affymax,Inc., +1-650-812-8722; or media, Daryl Messinger of WeissComm Partners,Inc., +1-415-999-2361, or daryl@weisscommpartners.com
Web site: http://www.affymax.com/
