Affymax, Inc. Announces Results Of Hematide(TM) Phase 2 Trial To Be Presented At 2005 American Society of Hematology Annual Meeting

PALO ALTO, Calif., Dec. 5 /PRNewswire/ -- Affymax, Inc., a clinical-stage pharmaceutical company, today announced that Phase 2 clinical trial results of Hematide(TM) in patients with anemia due to chronic kidney disease (CKD) will be presented at the 47TH Annual Meeting of the American Society of Hematology in Atlanta. Hematide is 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.

The poster presentation (ASH abstract #3532), entitled “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),” will be given by Anne-Marie Duliege, M.D., M.S., Vice President, Clinical, Medical, and Regulatory Affairs for Affymax, on Monday, December 12 at 5:00 p.m. EST. The poster will be available for viewing in Hall B beginning at 10:30 a.m. that day.

The trial is a randomized, double-blind, placebo-controlled, dose-escalation study evaluating a single intravenous injection of Hematide administered to patients with CKD. The study found that Hematide was well tolerated and demonstrated potent and sustained erythropoietic activity of the same magnitude as that observed in healthy volunteers.

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, which is being developed to treat anemia, is designed to have potential benefits, including uncomplicated chemical synthesis, low immunogenicity, room temperature storage, and simplified dosing characterized by monthly administration.

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 on hemodialysis, and in a Phase 2b multi-center, open-label, dose-finding trial in Europe in patients with CKD who are not on dialysis and 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

Anemia, a deficiency of red blood cells, is becoming increasingly prevalent in the United States. 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.

Severe fatigue associated with anemia affects more than 75 percent of all cancer patients undergoing chemotherapy. Anemia can cause cancer therapies to be less effective, can compromise the ability of patients to complete chemotherapy regimens, and can diminish their quality of life.

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.

Affymax, Inc.

CONTACT: Mary Fermi, Senior Director, Commercial Development of Affymax,Inc., +1-650-812-8722; or Daryl Messinger of WeissComm Partners, Inc.,+1-415-999-2361, or daryl@weisscommpartners.com, for Affymax, Inc.

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