NanoViricides initiates influenza study
Oct 14, 2013 (MarketLine via COMTEX) --
NanoViricides, Inc., a nanobio-pharmaceutical company, has initiated the initial non-GLP toxicology evaluation of its optimized injectable FluCide drug candidate.
The non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts. The results of this study will provide the basis and focus for the IND-enabling GLP safety and toxicology studies of FluCide that are required for the IND submission to the US FDA. These IND-enabling GLP safety and toxicology studies will be performed by BASi Toxicology Services in West Lafayette, IN.
The Company has previously reported that its FluCide candidate was highly effective in animal models of different influenza A virus strains. In those efficacy studies of FluCide, no safety or toxicology concerns were observed. As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner.
The Company is considering two separate indications for this injectable FluCide drug. The first is hospitalized patients with severe influenza.
The second planned indication would be for outpatients with influenza. The Company is hopeful that the outpatient treatment will likely be a single, small injection, at the first clinical visit with no follow-on treatment needed.
The Company is also developing an oral version of FluCide. The oral FluCide development will follow and benefit from the development of injectable FluCide. When approved, the oral FluCide would replace the injection of FluCide in out-patient cases.
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