SAN DIEGO, Dec. 7 /PRNewswire/ -- Affymax, Inc. today announced that it presented preclinical data showing that its lead product candidate, Hematide(TM), a peptide-based erythropoiesis stimulating agent (ESA), had pronounced effect on red blood cell production. In addition, pharmacokinetic studies in several different animal models demonstrated the compound's extended plasma half-life. Hematide is currently being evaluated in a Phase I clinical trial investigating its safety, pharmacokinetics and effect on reticulocytes and hemoglobin. It is being developed for the treatment of anemia in patients with chronic kidney disease and cancer.
"Preclinical data indicate that Hematide is a potent erythropoiesis stimulating agent with prolonged half-life and slow clearance times," stated Robert B. Naso, Ph.D, Affymax's executive vice president of research and development. "We anticipate that similar prolonged clearance will be observed in the clinic, potentially enabling dosing intervals of once every 4 weeks. This may translate into better patient outcomes through improved convenience and compliance."
In the poster presentation on Monday December 6, 2004 at the 46th American Society of Hematology Annual Meeting in San Diego, Affymax scientists reviewed pharmacology studies in various animal models including primates that indicated that following single dose administration of Hematide, the rise in hemoglobin was dose-dependent and the activity was of extended duration. Hematide is a peptide with a completely novel amino acid sequence that is unrelated to erythropoietin or any other known naturally-occurring human sequences. Antibodies generated experimentally to Hematide do not cross-react with recombinant human erythropoietin and therefore, researchers concluded that Hematide is unlikely to cause pure red cell aplasia and loss of potency for either recombinant erythropoietin receptor agonists or for the patient's endogenous erythropoietin.
ESAs have been used successfully to manage the anemia of patients with chronic kidney disease and cancer-related anemia. In these patient groups, ESA therapy has dramatically reduced the need for blood transfusions, has decreased anemia associated morbidity, and has led to an improvement in quality of life for those who have responded to therapy. Hematide represents a next-generation product that, if proven safe and effective in clinical trials, may improve anemia treatment and offer patients and physicians an alternative therapy.
Affymax, Inc. is a development stage pharmaceutical company that is creating novel peptide drugs for the treatment of various blood, cancer and kidney diseases. Affymax is rapidly building a rich pipeline of novel peptide drugs against clinically validated targets that will provide superior product profiles over therapeutic proteins. Advantages of peptide-based drugs can include reduced immunogenicity, improved dosing convenience, flexible storage and uncomplicated chemical synthesis. Hematide(TM), the Company's first product to enter the clinic, is a peptide-based drug designed to stimulate the production of red blood cells. It is being developed for various indications, including the treatment of anemia associated with chronic kidney disease and cancer. The Company is also advancing a peptide that is an agonist of the G-CSF receptor and has entered into a research collaboration with EntreMed for the synthesis and development of novel peptides that mimic the function of certain fragments of tissue factor pathway inhibitors. For more information go to http://www.affymax.com/.
CONTACT: Mary Fermi, Senior Director of Affymax, Inc., +1-650-812-8700,or http://www.affymax.com/; or media, Daryl Messinger of WeissComm Partners,+1-415-999-2361, or firstname.lastname@example.org, for Affymax