Oct 9 2013
NanoViricides, Inc., reports that it has initiated the initial non-GLP toxicology evaluation of its optimized injectable FluCide® drug candidate. This study is an important step in the drug development pathway for FluCide.
The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway.
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 U.S. 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. This work is currently in progress.
The Company is considering two separate indications for this injectable FluCide drug. The first is hospitalized patients with severe influenza. 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 increase those numbers by an order of magnitude.
There is a well known unmet medical need for treatment of these hospitalized patients as current influenza treatments have limited effectiveness because of the severity of the infection. A highly effective drug should receive rapid widespread acceptance.
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. During the 2009 H1N1 “swine flu” pandemic, there were approximately 61 million cases of out-patient influenza in the USA alone. A single course treatment for out-patients is a highly sought after goal in influenza therapeutics.
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.