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BioCryst Pharmaceuticals today announced the initiation of a Phase II study of intramuscular (i.m.) peramivir for the treatment of seasonal influenza
BIRMINGHAM, AL, USA | July 10, 2008 | BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the initiation of a Phase II study of intramuscular (i.m.) peramivir for the treatment of seasonal influenza.
The double-blind, placebo-controlled, parallel group Phase II trial will compare the efficacy of a single 600 mg injection of i.m. peramivir to placebo in the treatment of seasonal influenza. The dose was selected based upon an analysis of a recently completed Phase I study of a new, more concentrated 150 mg/ml formulation of i.m. peramivir, as well as prior studies of peramivir in patients with influenza. The Phase II study will utilize the new, more concentrated 150 mg/ml formulation and needle length guidelines established in recently conducted pharmacokinetic studies.
The primary endpoint of BioCryst's Phase II trial is improvement in time to alleviation of symptoms in patients. Secondary endpoints include reduction in viral titers and safety and tolerability. The trial is expected to enroll approximately 320 patients and will be conducted in the Southern Hemisphere.
"Conducting this study with our new, more concentrated formulation allows us to test peramivir in the outpatient setting at a higher dose than previously evaluated," stated Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "We are confident the results of this study will move us one step closer to offering a novel and important therapeutic option for the treatment of influenza infections."
About BioCryst
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The Company is advancing multiple internal programs toward potential commercialization including forodesine HCl in oncology, BCX-4208 in psoriasis and peramivir in seasonal and life-threatening influenza. BioCryst is collaborating with Mundipharma for the development and commercialization of forodesine HCl in markets across Europe, Asia, Australia and certain neighboring countries. In January 2007, the U.S. Department of Health and Human Services (HHS) awarded a $102.6 million, four-year contract to BioCryst to advance development of peramivir to treat seasonal and life-threatening influenza. In February 2007, BioCryst established a partnership with Shionogi & Co. to develop and commercialize peramivir in Japan. For more information about BioCryst, please visit the Company's web site at http://www.biocryst.com.
SOURCE: BioCryst Pharmaceuticals, Inc. |
