NanoViricides, Inc. (the "Company") 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. This is important as the liver and kidneys are major organs involved in drug toxicity. In addition, FluCide showed no adverse effects on the lungs from the treated animals. This is very important because the respiratory system is a primary site of influenza virus infection and tissue damage. These strong safety findings were seen at all doses tested, even at the maximum feasible dose (MFD). MFD was much higher than the therapeutic dose range used to treat influenza virus infections in our animal model efficacy studies. FluCide was administered intravenously by tail-vein injections or by infusion in this study. The non-GLP safety/toxicology study was conducted at KARD Scientific in Massachusetts.
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. These GLP studies will be performed on both large and small animals at the BASi facility in Indiana.
A critical step in FluCide drug development is the ability to produce clinical scale drug product. The Company has previously reported that the renovation of its facility in Shelton, CT, for its new clinical scale production plant is in the construction phase with projected completion during Q1 2014. The Company is performing certain scale up studies for manufacturing FluCide at its current facility.
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. In the USA, there are approximately 300,000 severe influenza cases that require hospitalization every year resulting in approximately 40,000 to 50,000 deaths. A pandemic would likely increase those numbers by an order of magnitude. The second planned indication for injectable FluCide would be for out-patients with influenza. During the 2009 H1N1 “swine flu” pandemic, there were approximately 61 million cases of out-patient influenza in the USA alone.
The market size for anti-influenza drugs is currently estimated to be in the billions of dollars worldwide. The Company believes that if its FluCide® drug becomes available, the influenza drug market size could become substantially larger. Historically, it is well known that when a highly effective therapeutic becomes available, the market size for the underlying indication expands dramatically.
The Company is also continuing the development of its oral FluCide drug candidate that is expected to follow the injectable FluCide into clinical development. We believe that the oral FluCide also would be found to be extremely safe, based on the excellent safety of the injectable FluCide drug candidate as demonstrated by this non-GLP study. Orally bioavailable FluCide is expected to significantly expand the market size for our anti-influenza program.
NanoViricides, Inc. is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.