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Clinical Research Management gets contract for trials of therapeutics against infectious diseases
Date:8/7/2008

he infectious disease researchers at Johns Hopkins University for many years. We knew that their expertise with early stage infectious disease would make JHU an ideal NIAID testing site for new drugs against infectious diseases," said Tifft.

Under the seven-year contract, each site will receive approximately $5.5 million to perform Phase I Clinical Trials for Therapeutics against Infectious Diseases. The units will assess the safety of investigational therapeutic products against viral (other than HIV), bacterial, parasitic and fungal infections, including biodefense pathogens, and emerging and re-emerging infectious diseases such as Severe Acute Respiratory Syndrome (SARS) and bird flu.

"This is a major award for Cleveland and a testament to the history and depth of experience we have in infectious diseases and clinical research," said Robert A. Salata, M.D., who will lead the new Phase I Unit for Case Western Reserve University and University Hospitals Case Medical Center.

"We continue to see emerging infections and resurgence of old infections. Drug discovery and testing of new compounds is critical in our fight against these new and old pathogens. This unit will allow first-in-human testing of new therapeutic agents for safety and tolerance," said Dr. Salata, who is chief of the Division of Infectious Diseases and HIV Medicine at UHCMC, and professor and executive vice chair of the Department of Medicine at Case Western Reserve University.

Phase I trials are the first stage of testing in humans. Normally, a group of about 20 to 80 healthy volunteers will be involved. These trials will be conducted in an inpatient clinic at UHCMC, where the subjects can be observed by full-time staff. Phase I trials also normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found.

The therapeutics will be tested in healthy volunteers, men and women 18 to 45 y
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Contact: George Stamatis
george.stamatis@UHhospitals.org
216-844-3667
University Hospitals of Cleveland
Source:Eurekalert

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