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Affymax Presents Results From Ongoing Phase 2 Clinical Trial of Hematide(TM) in Anemic Cancer Patients Receiving Chemotherapy

Posted on: Monday, 11 December 2006, 09:00 CST

PALO ALTO, Calif., Dec. 11 /PRNewswire/ -- Affymax, Inc., a clinical-stage pharmaceutical company, today announced the presentation of results from an ongoing Phase 2, open-label, multicenter, dose-finding clinical trial of Hematide(TM) in anemic cancer patients receiving chemotherapy. Hematide, a novel peptide-based drug designed to stimulate the production of red blood cells, is the Company's first product candidate to enter the clinic. Hematide is being evaluated in Phase 2 clinical trials for the treatment of anemia associated with chronic kidney disease and in anemic cancer patients undergoing chemotherapy. The data were presented in a poster session (Abstract #1290) at the 48th Annual Meeting of the American Society of Hematology (ASH) in Orlando.

In the study, patients received up to four doses of Hematide administered subcutaneously every three weeks. Preliminary results from the first two cohorts of patients (15 patients who received a dose of 0.1 mg/kg and 15 patients who received a dose of 0.15 mg/kg) showed that Hematide increased both reticulocyte and hemoglobin levels. A pronounced reticulocyte response was observed following each dose of Hematide, and at least 50 percent of patients in both dose groups had hemoglobin increases greater than or equal to 1 g/dL by week 7, which appeared to be sustained through week 13. Hemoglobin values achieved levels of greater than or equal to 11 g/dL in at least 50 percent of patients by week 10 and were sustained through week 13.

Multiple doses of Hematide were well tolerated when administered subcutaneously. Rates of adverse events were similar in each dose group. The most frequently reported adverse events included diarrhea, vomiting, dyspnea (each reported by three patients), nausea, fever, headache, neutropenia, renal impairment/reduced renal function, and shortness of breath (each reported by two patients).

"The finding that Hematide increased hemoglobin levels in oncology patients with anemia is promising and warrants further study, as anemia is a common complication of cancer and cancer treatment, and new treatments are needed," said Anne-Marie Duliege, M.D., M.S., vice president of Clinical, Medical, and Regulatory Affairs for Affymax. "This Phase 2 study is currently ongoing and is evaluating additional dose levels of Hematide in subsequent patient cohorts."

Hematide Preclinical Data Also Presented at ASH

Kathryn W. Woodburn, Ph.D., senior director of Preclinical Development for Affymax, presented a poster (Abstract #1143) at the ASH Annual Meeting entitled "Erythropoiesis Equivalence, Pharmacokinetics, and Antibody Analysis Following Subcutaneous and Intravenous Hematide Administration in Cynomolgus Monkeys." This preclinical study evaluated the pharmacokinetics, erythropoietic response, and the potential of Hematide to induce the formation of antibodies following subcutaneous and intravenous administration in an animal model. Study results showed that repeated dosing of Hematide increased reticulocytes, red blood cells, hematocrit, and hemoglobin levels in an animal model when administered intravenously or subcutaneously and did not cause the development of detectable levels of Hematide-specific antibodies.

Dr. Woodburn also presented a poster (Abstract #1155) entitled "Chronic Preclinical Safety Evaluation of Hematide, a PEGylated Peptidic Erythropoiesis Stimulating Agent, in Monkeys."

About Affymax, Inc.

Affymax, Inc. is a clinical-stage biopharmaceutical company developing novel peptide-based drugs to improve the treatment of serious and often life- threatening conditions. Affymax's lead product candidate, Hematide, is currently in Phase 2 clinical trials for the treatment of anemia associated with chronic kidney disease and cancer.

Affymax, Inc.

CONTACT: Mary Fermi, Senior Director, Commercial Development, ofAffymax, Inc., +1-650-812-8722; or Jani Bergan of WeissComm Partners,+1-415-946-1064 or jbergan@weisscommpartners.com, for Affymax, Inc.

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

Source: PRNewswire

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