PALO ALTO, Calif., July 26 /PRNewswire/ -- Affymax, Inc. today announced that Anne-Marie Duliege, M.D. has joined the company as Vice President of Clinical, Medical and Regulatory Affairs. Dr. Duliege will be responsible for the design and initiation of clinical trials for Affymax's promising lead product candidate Hematide(TM), a peptide that stimulates production of red blood cells. She has a record of significant accomplishment in executing Phase I through IV regulatory filings and clinical studies in cardio-pulmonary medicine, infectious disease and immunology.
"We are especially pleased to have Anne-Marie join our exceptional management team and lead our clinical and regulatory efforts," stated Arlene M. Morris, Affymax's President and CEO. "Anne-Marie will be instrumental to our successfully navigating the next exciting stage in Affymax's transition towards becoming a product development company as we prepare to initiate clinical trials for Hematide. Her experience designing and implementing broad clinical studies for the treatment of difficult diseases will be enormously useful to our overall product development programs."
For the last 12 years, Dr. Duliege has served as part of the clinical development team at Chiron Corporation with her last position there as Senior Medical Director and Head of Internal Medicine. In that role, she was responsible for the global clinical development of Chiron's infectious disease and immunology pipeline as well as for supervision of certain projects in cardio-pulmonary medicine. She has had considerable experience managing outside investigators, presenting to the regulatory agencies and coordinating the activities of the regulatory, biostatistics, medical affairs, and oncology departments. While at Chiron, she led the team that designed and implemented a Phase III clinical study of IL-2 for the treatment of HIV, which enrolled 2,000 patients in 11 countries and 135 study centers. Dr. Duliege was also involved with a number of Phase I and Phase II trials for HIV and CMV vaccines, as well as several other late stage clinical trials in other infectious disease and immunology areas.
Prior to joining Chiron, Dr. Duliege was a Senior Research Physician at Genentech, Inc. where she was responsible for clinical evaluation and strategy for an HIV vaccine. Before Genentech, she was with Stanford University Medical Center as an Epidemiologist; she continues to practice at the Lucille Packard Children's Hospital at Stanford. She was an Epidemiologist at Kremlin-Bicetre Hospital, National Institute of Science & Medical Research in Paris, France from 1988-1989, and a Visiting Fellow in Pediatric Immunology at UCSF in 1988. Dr. Duliege earned her Doctor of Medicine degree from Paris Medical School; she also earned an MS in Epidemiology at Harvard School of Public Health and an MS in Biostatistics at Paris Medical School.
About Affymax
Affymax, Inc. is a drug discovery and development company that is creating novel peptide drugs for the treatment of cancer, immune-mediated and related diseases. Affymax's strategy is to rapidly build a rich pipeline of peptide drugs against clinically validated targets that will provide superior product profiles over therapeutic proteins. The company's first drug candidate, Hematide(TM), is a synthetic peptide erythropoietin receptor agonist that stimulates the production of red blood cells. Hematide has a completely novel sequence that is unrelated to erythropoietin or any other known naturally- occurring human sequences. In animal and laboratory studies Hematide has demonstrated an improved efficacy profile and superior stability compared to recombinant protein products. Affymax plans to initiate clinical trials with Hematide in late 2004, and is also developing peptide receptor agonists to other important hematologic receptors. Affymax peptides should have several advantages compared to protein therapeutics including, the potential to reduce immunogenicity, improved dosing convenience, room temperature storage, and manufacturability.
Affymax, Inc.