Aethlon Medical, the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, has entered into a definitive agreement with DaVita Clinical Research (DCR) to provide clinical management services to support the forthcoming feasibility study of the Aethlon Hemopurifier.
The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon further announced that the Principal Investigator for this study will be Dr. Stephen Z. Fadem.Aethlon Hemopurifier.
The clinical trial site location will be DaVita MedCenter Dialysis in Houston. Dr. Fadem is co-medical director of DaVita MedCenter Dialysis and this center is one of the three largest dialysis centers in the country with 72 treatment stations.
Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that allows the company to initiate human feasibility studies of the Aethlon Hemopurifier in the United States. Under the feasibility study protocol, Aethlon is to treat ten ESRD patients infected with hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease indications.
"The combination of DCR, DaVita MedCenter Dialysis, and Dr. Fadem provides Aethlon with the ideal team of professionals and infrastructure with which to conduct our infectious disease clinical study. Additionally, their proximity to managing director, Anderson Cancer Centre and other specialty facilities located within the Texas Medical Center provide for a unique location to conduct future clinical investigations of Hemopurifier therapy in a variety of life-threatening health conditions," stated Aethlon Medical chief executive officer, Jim Joyce.
DCR is a specialty contract research organisation (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners Inc, DCR has access to one third of the total US ESRD patient population and maintains a network that exceeds 150 investigative physicians' practices at more than 250 clinical sites.
Dr. Fadem is a practicing Houston nephrologist and is currently the Chief Medical Officer at Kidney Associates, PLLC and the Medical Director for the Houston Kidney Center Integrated Service Network at DaVita Kidney Care, a division of DaVita HealthCare Partners Inc. He began practice in 1978 after completing a renal fellowship at The University of Texas Health Science Center in San Antonio. He is a graduate of the University of Oklahoma College of Medicine, and did his internal medicine residency at The University of Texas and managing director, Anderson Hospital in Houston. He is a Clinical Professor of Medicine at Baylor College of Medicine.
He is a Fellow of the American College of Physicians, Fellow of the American Society of Nephrology, diplomat of the American Board of Quality Assurance and Utilisation Review Physicians (CHCQM - Certified Health Care Quality Management), and a member of the International Society of Nephrology, Renal Physicians Association, the American Association of Kidney Patients and The National Kidney Foundation. He is active in quality management, credentialing and peer review for his dialysis centers.
On a national level, he is co-chairman of the Medical Advisory Board of the American Association of Kidney Patients, and a past vice-president of the Board of Directors. He has also served on the Board of Directors of the Renal Physicians Association, and actively serves on two national RPA committees, the Government Affairs Committee and the Health Finance Committee. Dr. Fadem has been active in the Forum of ESRD (end stage renal disease) Networks and was a member of the CMS Clinical Performance Measures Committee. He lectures frequently on dialysis management, preventive nephrology, vascular calcification, anemia, patient education, CKD education, computer technology and computer security. Dr. Fadem is a co-editor of AAKP Renalife and is a reviewer for several peer reviewed journals.
Dr. Fadem has been nationally recognised by receiving the American Association of Kidney Patient's Nova Award, the National Kidney Foundation's Distinguished Service Award. He has also received the National Kidney Foundation's Presidents Award and the Myron L. Jenkins Award. He has been awarded the Peter Lundin Award for his contributions to patient education and The Visionary Award for his contributions to CKD education. He is the 2013 winner of the DaVita Core Value Award for Continuous Improvement. He has been named as one of America's Top Doctors by Castle Connolly and US News and World Report, and is consistently ranked as a Top Doctor in Houston by Texas Magazine.