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December 2, 2013
07:04 EDTNNVCNanoViricides reports safety profile of its FluCide drug candidate
NanoViricides reports that it has received results of detailed lab analysis studies from the initial non-GLP toxicology studies of intravenously administered FluCide. No overt adverse safety and toxicology effects were observed in this study of the company’s optimized FluCide broad-spectrum anti-influenza drug candidate, even at the maximum feasible dose level. These results are consistent with the preliminary findings of this study that the company has previously reported, and provide greater details of the safety of FluCide. Detailed laboratory analyses of samples from this non-GLP safety and toxicology study showed no overall systemic effects and no direct effects on the primary organs. This includes liver and kidney tissues as well as liver and kidney function. These results support the company’s positive findings in animals that were infected with different influenza A virus strains. In those studies, no safety or toxicology concerns were observed. The company has previously reported that its FluCide candidate demonstrated extremely high anti-influenza activity in lethal infection animal models using multiple influenza A subtypes. The extremely high anti-influenza activity coupled with the strong safety data were the basis for the selection of this FluCide candidate for further drug development. As previously reported, the results of this study will provide both the basis and focus for the GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. The company is considering two separate indications for this injectable FluCide drug. The first is hospitalized patients with severe influenza. Current influenza treatments have limited effectiveness in this setting because of the severity of the infection. The second planned indication for injectable FluCide would be for out-patients with influenza. The company is also continuing the development of its oral FluCide drug candidate that is expected to follow the injectable FluCide into clinical development.
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