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Affymax Presents Hematide(TM) Preclinical Data At American Society of Nephrology Renal Week 2005

Posted on: Friday, 11 November 2005, 09:00 CST

PALO ALTO, Calif., Nov. 11 /PRNewswire/ -- Affymax, Inc., a clinical-stage pharmaceutical company, today announced the presentation of preclinical data on Hematide(TM), a novel peptide-based drug designed to stimulate the production of red blood cells and the Company's first product candidate to enter the clinic. The poster presentation (Abstract # F-PO654), entitled "Distribution of the Novel Erythropoiesis-Stimulating Agent Hematide Using Quantitative Whole-Body Autoradiography in Sprague-Dawley Rats," will be given by Kerstin K. Leuther, Ph.D., director and project manager at Affymax, today at the American Society of Nephrology's Renal Week 2005 in Philadelphia.

"This preclinical study used radioactively-labeled Hematide to generate valuable data on the distribution of Hematide in rodent models, including blood and plasma concentrations and time to elimination," said Dr. Leuther. "These data will be beneficial as we continue our ongoing evaluation of Hematide for the treatment of anemia in patients with chronic kidney disease."

"Preclinical and clinical trial results to date have shown that Hematide acts as a potent erythropoiesis-stimulating agent for the treatment of anemia in patients with chronic kidney disease and cancer," said Robert B. Naso, Ph.D., executive vice president, research and development at Affymax. "We believe Hematide is a breakthrough product that has several potential advantages over currently marketed treatments for anemia, and we are studying it in multiple Phase 2 trials in several target patient populations with significant unmet medical needs."

About Hematide

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 has potential advantages compared to therapeutic proteins, including uncomplicated chemical synthesis, greater stability than currently marketed products and room temperature storage. Other potential benefits of Hematide include low immunogenicity, monthly administration, simple dosing and rapid onset of action.

Phase 1 findings and early results from a Phase 2a study of Hematide in patients with CKD have provided initial safety data and proof-of-concept of erythropoietic activity. Results of a Phase 1 dose-finding study demonstrated that Hematide was well tolerated and that single doses of Hematide resulted in dose-dependent increases in circulating reticulocytes in healthy volunteers. In addition, Hematide achieved clinically and statistically significant increases in red blood cells and hemoglobin from baseline, which was sustained for at least four weeks. Increases in hemoglobin and reticulocytes are indications of red blood cell production.

Currently, Hematide is being studied in a Phase 2b open-label, repeat dose, dose-finding study in the U.S. in patients with end-stage renal disease (ESRD) on hemodialysis. Additionally, a Phase 2b multi-center, open-label, dose-finding trial in patients with CKD who are not on dialysis and have not been treated previously with erythropoietin is underway at clinical sites in Europe. 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 http://www.affymax.com/.

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, for Affymax

Web site: http://www.affymax.com/

Source: PRNewswire

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