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Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections
Date:2/23/2009

BIRMINGHAM, Ala., Feb. 23 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals (Nasdaq: BCRX) today announced that the full data set from an exploratory Phase 2 study of peramivir in patients hospitalized for influenza was presented by the study's Principal Investigator, Dr. Michael G. Ison, Assistant Professor, Divisions of Infectious Diseases and Organ Transplantation at Northwestern University Feinberg School of Medicine, during the XI International Symposium on Respiratory Viral Infections taking place in Bangkok, Thailand, February 19 through February 22, 2009. This exploratory Phase 2 trial compared the efficacy and safety of five days of therapy with either 200 mg intravenous (i.v.) peramivir per day, 400 mg i.v. peramivir per day or 75 mg oral oseltamivir twice-a-day, in patients who required hospitalization related to influenza.

The primary objective of the study was to evaluate time to clinical stability, which is a composite endpoint comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of endpoint has previously been used in pneumonia studies, but not in influenza. Secondary objectives of the study included evaluation of viral shedding, mortality, clinical relapse and time to resumption of usual activities. The primary efficacy population was defined as patients with confirmed influenza.

As reported in October 2008, there were no statistically significant differences in any of the efficacy endpoints between the three treatment arms, and peramivir was generally safe and well-tolerated at these dose levels. Evaluation of time to clinical stability, the primary endpoint, showed a median of 23.7 hours for peramivir 200 mg, 37.0 hours for peramivir 400 mg and 28.1 hours for oseltamivir (p=0.306). This exploratory endpoint was driven b
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