NanoViricides (NNVC) announced that its drug candidate NV-387 “is the weapon necessary” for combatting growing cases of measles worldwide, especially in the industrialized world including, USA, Canada, UK, and European Union. The company said, “NV-387 is possibly the only drug candidate that has been shown to be effective and safe in animal model studies of Measles virus in humanized h-CD150+ knock-in mice, as reported previously by NanoViricides. NV-387 has completed a Phase I clinical trial with no reported adverse events, indicating excellent safety and tolerability in humans. The development of NV-387 as a treatment for Measles can be accelerated under the US FDA programs. Measles is considered a rare orphan disease in the USA. As such, NV-387 for the treatment of Measles would qualify for an Orphan Drug Designation. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval/ The Company also plans to explore a “Fast Track” designation for the NV-387 Measles indication. If granted, a drug approval can occur on the basis of a successful Phase II clinical trial without requiring a Phase III clinical trial, which significantly reduces the timeline to approval. Measles has become an important disease of concern globally in the recent years for several reasons. Most importantly, Measles disease can wipe out the previously learned immunity of the patient against many infections, including from prior infections, and non-live virus vaccines, making the population vulnerable to viruses that were encountered previously. This is because Measles virus attacks the CD150-bearing immune cells that are responsible for memorizing the prior infections and mounting defenses against them later. Measles is possibly the most communicable diseases, spreading through aerosol, that is known to humans. In patients, it produces severe morbidity with skin rash, pain, fatigue, and other syndromes. Rarely it can cause a brain disease. Measles mostly affects children.”
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