LINCOLN, R.I., Nov. 13 /PRNewswire/ -- Nephros Therapeutics, Inc., a privately held biotechnology company focused on developing novel bio- replacement therapies to treat severe organ failure, announced the appointments of Richard B. Stead, MD, former Vice President of Clinical Research and Development at Immunex, as Chief Medical Officer and Karen M. Brennan as Senior Director of Clinical Operations. Having played key roles in the clinical development and approval of Epogen(R), Neupogen(R), and Novantrone(R), Dr. Stead brings to Nephros a comprehensive understanding of clinical and regulatory processes for some of the biotechnology industry's most important and successful therapies. Ms. Brennan will be responsible for the implementation of clinical operation plans for the Company's lead product candidate, Renal Bio-Replacement Therapy(TM), for acute renal failure, as it moves into Phase II clinical trials. Renal Bio-Replacement Therapy is intended to perform the fundamental aspects of the kidney via a two-cartridge system.
"With the addition of these two senior members to the Nephros team, we are well-positioned to execute our development plans for our Renal Bio-Replacement Therapy for the treatment of acute renal failure, a severe and expensive life- threatening condition," said Mr. Richard A. Andrews, Nephros Therapeutics' President and CEO. "We anticipate initiating Phase II trials for Renal Bio- Replacement Therapy in December 2003 and Dr. Stead's and Ms. Brennan's expertise will ensure that we move towards commercialization in the most effective manner. I look forward to working with them in bringing Nephros' Renal Bio-Replacement Therapy to market."
Dr. Stead brings to Nephros more than 15 years of experience in the biotechnology industry. He has directed clinical trials, as well as played significant roles for in- and out- licensing, and preclinical research and development of a number of products. Dr. Stead served as Vice President of Clinical Research and Development and played a key role in the Food and Drug Administration (FDA) approval of Novantrone(R) for multiple sclerosis. While at Immunex, he was responsible for oversight of clinical development of all products in the Specialty Therapeutics Franchise and also worked closely with the sales and marketing team on the commercialization of both Novantrone(R) and Leukine(R). Since leaving Immunex after its merger with Amgen in 2002, he has worked with a number of smaller biotechnology companies as an independent consultant. Prior to Immmunex, Dr. Stead held various positions in clinical development at Amgen, most recently as Medical Director and Senior Clinical Scientist. He played a key role in the clinical development, FDA approval and commercialization of the Company's first two products, Epogen(R) and Neupogen(R). He also served on Amgen's International Clinical Overview Group, which was responsible for review and oversight of all Amgen clinical protocols and regulatory submissions. Dr. Stead holds a BS in Molecular Biology from the University of Wisconsin and an MD from Stanford University's School of Medicine. He completed his training in internal medicine with a post-doctoral fellowship in hematology at Brigham & Women's Hospital and Harvard Medical School. Following the completion of a second post-doctoral fellowship at the National Cancer Institute, he joined the Fred Hutchison Cancer Research Center where he conducted research in the field of gene therapy.
Ms. Brennan has extensive experience in clinical operations. Before joining Nephros, she was a Principal at QuEST Consulting, providing on-site collaboration and consulting services in the areas of clinical project management, clinical trial management, and Good Clinical Practices. Prior to QuEST, she was Director of Clinical Operations at Cubist Pharmaceuticals, where she was responsible for operational support and guidance of activities associated with all late-stage (Phase III onwards) clinical research studies in support of registration and marketing development plans. She has also held a number of positions at Applied Analytical Industries, most recently as Vice President of Clinical Affairs and Project Management. Ms. Brennan holds a BSN from the University of Massachusetts (Amherst) and an MBA from Suffolk University. She is also currently a part-time faculty member at Northeastern University for the Graduate Certificate Program in Clinical Trial Design and Project Management.
About Nephros Therapeutics, Inc.
Nephros Therapeutics is a biotechnology company whose mission is to treat severe organ failure with novel bio-replacement therapies. The company's lead product is Renal Bio-Replacement Therapy (RBT(TM)), designed to treat acute renal failure (ARF) patients in the intensive care unit by providing vital physiological functions as transitional support to enable recovery. With promising data from preclinical and preliminary human clinical studies, Nephros plans to initiate Phase II clinical trials for RBT(TM) in December 2003. The Company has gathered the requisite management, clinical, regulatory, manufacturing, and business development skills and resources for commercialization, and is channeling them towards bringing RBT to the market as expeditiously as possible. For more information, please visit http://www.nephrostherapeutics.com/.
Richard A. Andrews Megan Burling
President & CEO Account Supervisor
Nephros Therapeutics, Inc. Feinstein Kean Healthcare
(401) 333-3789 (617) 577-8110
Nephros Therapeutics, Inc.