BioCryst Pharmaceuticals have started a Phase II trial in hospitalized influenza patients using an intravenous formulation of peramivir, the company's lead influenza neuraminidase inhibitor.
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The trial will compare the efficacy and safety of peramivir administered intravenously once daily for five days versus oral oseltamivir administered twice daily for five days in adults who are hospitalized with acute influenza. The current study will take place during the present and upcoming influenza seasons with enrollment expected in the US, Canada, Hong Kong, Singapore, Australia, New Zealand, and South Africa.
In addition to the trial announced today, BioCryst is currently conducting a separate phase II trial using an intramuscular formulation of peramivir in individuals with influenza in the outpatient setting. Both studies are based on the positive phase I clinical data obtained in 2006 and reported at the 46th Annual ICAAC meeting in September, 2006.
BioCryst is advancing the clinical development of peramivir under terms of a contract from the US Department of Health and Human Services which on January 3, 2007 awarded BioCryst a $102.6 million, four-year contract to develop peramivir for the treatment of seasonal and life-threatening influenza.
Jon Stonehouse, president and CEO of BioCryst, said: “The Centers for Disease Control estimates that over 200,000 persons are hospitalized and 36,000 persons die each year in the US due to influenza and its complications. There is currently no drug for influenza that is available as an injection for hospital use and this intravenous formulation of peramivir holds particular promise in this indication.”
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