NanoViricides, Inc. (the "Company") reports that its optimized injectable FluCide® drug candidate was found to be well tolerated in a non-GLP small animal safety/toxicology study. This study is an important step in the drug development pathway for FluCide. This study will provide guidance for the IND-enabling GLP safety and toxicology study.
The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway. This non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts.
Dr. Krishna Menon, VMD, PhD, CEO of KARD Scientific, advised the Company after the completion of this short study, that mice treated with the maximum feasible dose of FluCide in a one hour infusion protocol remained healthy throughout the course of the study. No overt behavioral or clinical signs of any toxicity were observable, even at this highest possible dose level. The Company expects to receive a complete report of all laboratory and clinical data including blood chemistry and histopathology analysis soon.
These preliminary results support the Company’s positive findings in efficacy studies using animal models of different influenza A virus strains wherein no safety or toxicology concerns were observed. The Company has previously reported that our injectable FluCide drug candidate was highly effective in animal models of different influenza A virus strains.
The GLP safety and toxicology study is expected to require relatively large quantities of the FluCide drug candidate [GLP refers to “(current) Good Laboratory Practices,” a detail-oriented formal methodology]. The Company has undertaken the necessary process development, and scale-up chemistry optimization studies 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. 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. 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.
The second planned indication for injectable FluCide would be for outpatients 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 several billions of dollars worldwide. The Company believes that if its FluCide® drug becomes available, the influenza drug market size could become substantially larger. It is well known that when an effective treatment for a disease becomes available, the market size explodes and the novel effective treatment captures a substantial portion of the market.