Rho Brings Multi-Million Dollar Federal Contract to RTP Area

September 4, 2008

Company News Release

Rho, Inc., and the National Institutes of Health (NIH), is pleased to announce that the National Institute of Allergy and Infectious Diseases (NIAID) has awarded Rho a six-year, $38.9 million contract to provide biostatistical, data management, and safety services to the Immune Tolerance Network (ITN).

Rho Brings Multi-Million Dollar Federal Contract to RTP Area

Media Contact: Courtney Bilan (Courtney_Bilan@RhoWorld.com; 919.595.6373)


CHAPEL HILL, NC – Rho, Inc., a scientific/medical contract research organization that serves the biotechnology and pharmaceutical industries and the National Institutes of Health (NIH), is pleased to announce that the National Institute of Allergy and Infectious Diseases (NIAID) has awarded Rho a six-year, $38.9 million contract to provide biostatistical, data management, and safety services to the Immune Tolerance Network (ITN). In addition, Rho will provide similar services to the NIAID-sponsored Asthma and Allergic Diseases Cooperative Research Centers (AADCRCs).


“These programs are special in several ways,” said Dr. Ronald Helms, Rho’s Chief Scientific Officer. “The Triangle area is a hotbed of immunology research, and these newly awarded programs will interact with ITN-sponsored immune research and asthma research projects already underway. ITN is conducting world-class, leading-edge research in transplantation, autoimmune diseases, diabetes, and similar areas that will dramatically improve patients’ lives – both quality of life and length of life – in the next few years. Winning this contract has palpably raised the level of excitement at Rho.”


The Immune Tolerance Network (ITN), headquartered at the University of California, San Francisco, involves approximately 70 distinguished investigators from more than 50 institutions worldwide, including UNC and Duke. The overall objective of the network is to accelerate the evaluation of promising approaches for the introduction and maintenance of immune tolerance.


“Normally our immune systems attack and conquer ‘antigens’, or foreign substances in our bodies,” explained Dr. Helms. “This is good when our system is curing a bacterial or viral infection; it’s not so good when our system is attacking a transplanted organ or when it mistakenly attacks a part of us that is actually not foreign but an integral part of us. Immune tolerance research attempts to find methods of teaching one’s immune system to tolerate, rather than attack, specific antigens like transplanted organs that stimulate autoimmune responses.
“Progress is exciting! For example, in one ITN program, 10 organ transplant subjects have been totally weaned from immunosuppressive drug treatment, a truly significant achievement. There are literally millions of people in the US alone whose lives may be significantly affected by the results of the ITN research programs.”


The NIAID established the AADCRCs to promote integrated, multidisciplinary basic and clinical research on the immunologic mechanisms underlying the onset and progression of asthma and allergic diseases. The overall goal of this program is to improve the diagnosis and treatment of asthma and allergic diseases and to provide a rational foundation for the development of effective therapeutic and prevention strategies.


Rho will serve as the Statistical and Data Coordinating Center (SDCC) for clinical and non-clinical research activities carried out by the ITN with the responsibility for a broad range of support functions, including statistical design and analysis; clinical data collection; database storage and management; quality control; reporting and associated training for clinical site personnel; safety oversight; preparation of study-related materials; and clinical study website development and maintenance. Rho will also serve as the SDCC for the AADCRCs to provide assistance in the statistical design, analysis, and final reporting for clinical trials and mechanistic studies.


Herman E. Mitchell, PhD, Vice President of RhoFED, Statistician, and Epidemiologist, has been named Principal Investigator (PI) for this project. He has 26 years of NIH multi-center coordinating experience and for the past 18 years has been involved in clinical research related to asthma among inner-city children. In addition to his extensive research in asthma, Dr. Mitchell has worked with the National Cancer Institute to establish Coordinating Centers in Belarus and Ukraine for studies of the Chernobyl project and has served as Co-PI for Coordinating Centers for HIV-AIDS (NIAID) and Obesity (National Heart, Lung, and Blood Institute).


Rho, Inc. is a full-service CRO that enhances the quality and speed of clinical trials, helping pharmaceutical and biotechnology companies swiftly develop new products. Rho has provided high-quality services in the areas of clinical operations, clinical data management, statistical programming, biostatistics, medical writing, and custom systems development since 1984. With over 325 professionals located in Chapel Hill, NC, and Newton, MA, Rho is committed to providing accurate, efficient, and comprehensive services to clients worldwide.
For additional information about Rho, Inc. and its services, please visit the web site at www.RhoWorld.com.

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