NanoViricides reports results of influenza drug candidate study
The detailed lab analysis showed no overt adverse safety and toxicology effects from the company's broad-spectrum anti-influenza candidate, even at the maximum feasible dose level. The results were consistent with the preliminary findings of the study.
Detailed analyses of samples from the study showed no overall system effects and no direct effects on the primary organs, including liver and kidney tissues. The results supported the company's previous findings in animal studies that showed no safety or toxicology concerns.
NanoViricides previously reported that its FluCide candidate demonstrated very high anti-influenza activity in lethal infection animal models using multiple subtypes of influenza A. The high anti-influenza activity along with the positive safety data were the basis for selecting FluCide for further drug development.
The results of the study will provide the basis and focus for the GLP safety and toxicology studies of FluCide that are required for the investigational new drug submission to the U.S. Food and Drug Administration.
NanoViricides is considering two separate indications for injectable FluCide: hospitalized patients with severe influenza and outpatients with influenza. In the U.S., there are approximately 300,000 severe influenza cases that require hospitalization annually, resulting in 40,000 to 50,000 deaths. During the 2009 H1N1 swine flu pandemic, there were approximately 61 million cases of outpatient influenza in the U.S.