NanoViricides Inc. yesterday announced it has selected a clinical candidate, now designated NV-INF-1, for FDA submission in its highly successful FluCide™ anti-influenza therapeutics program. Based on NV-INF-1′s demonstrated efficacy as a highly effective anti-influenza drug in animal studies, NanoViricides said it believes the candidate will be rapidly and widely recognized as treatment for severe influenza.
FDA consultants are assisting the company in developing additional information on NV-INF-1 to prepare for the pre-IND application to the FDA.
NV-INF-1 is expected to be effective against most strains and types of influenzas, including novel epidemic influenza strains such as the swine flu; seasonal flu such as H1N1, H3N2; highly pathogenic types such as H7N and H9N; and the “bird flu,” or H5N1. The company plans on designating NV-INF-1 for two separate indications: high strength dosage form for hospitalized patients with severe influenza; and a single course therapy for the out-patients with less severe influenza.
The company noted that the market size for anti-influenza drugs is currently estimated to be approximately $4 billion-$7 billion worldwide. If its FluCide™ drug becomes available, the company anticipates that the market could significantly increase.
Previous studies showed high efficacy for its optimized FluCide™ drug candidates, prompting the company to focus its efforts on advancing one of the tested optimized FluCide candidates as the clinical drug candidate.
NanoViricides’ development portfolio includes drugs against several viral diseases, including 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.
For more information visit www.nanoviricides.com
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