WEST HAVEN, CONNECTICUT -- Monday, August 4, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that it is restarting its drug development program to combat Ebola virus infections.
The recent Ebola outbreak in West Africa has been the deadliest so far, per the World Health Organization (WHO). Ebola virus causes a deadly disease, with 60% to 90% of infected people dying, depending upon the strain of the virus. Fortunately, it is transmitted only through close contact with an infected person's body fluids, and not through aerosol or the water route, thus limiting its transmission.
Currently, there are no licensed drugs or vaccines for Ebola, although some vaccines as well as some drug candidates have entered clinical trials.
Ebola virus infects a wide variety of human cell types, by using various attachment receptors to enter endosome structures inside cells. Upon entry, the virus binds to its cognate receptor, the Niemann-Pick C1 cholesterol transporter protein inside the late endosomes, fuses with the endosomal membrane, and thus enters the cytoplasm. It replicates, buds out of the cell, and the cycle repeats itself. The virus shuts down several of the host's immune system defenses, and thus gains an upper hand.
"We believe that with our 'intelligent nanomachines' approach we have the potential to develop superior therapeutics as compared to other approaches," said Anil R. Diwan, PhD, President of the Company.
"We are happy to restart the Ebola program, considering the public health impact of the Ebola virus infection," said Dr. Eugene Seymour, MD, MPH, CEO of the Company, adding, "We are in a strong financial position now, enabling us to work on this project while we continue to advance our FluCide™ and DengueCide™ therapies further towards clinical trials. We hope to create highly effective drugs against Ebola, similar to what we have achieved with our FluCide™ Influenza drug candidate."
The Company's first drug candidate, NV-INF-1, Injectable FluCide™, is designed to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load remained suppressed to this baseline level. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. NV-INF-1 also caused the lungs of treated animals to remain substantially healthier than the untreated control or oseltamivir-treated mice. Further, NV-INF-1 has been found to be extremely safe in preliminary safety/toxicology studies.
The Company currently has approximately $41 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials.
NanoViricides, Inc. now has its own drug manufacturing facility that is capable of producing sufficient quantities of an anti-Ebola drug after it is developed, for combating Ebola epidemics.
Approximately 729 people have died and 1300 infected from Ebola virus in the current epidemic. Two US health care workers, a doctor and a nurse, also contracted ebola infection. The doctor's health appears to be improving, at Emory University Hospital, said a recent news report. There is practically no public health risk from known cases such as these because of the extremely strong precautions that are taken in handling them. However, it takes anywhere from 2 to 20 days for ebola virus illness signs to appear after infection. In addition, the virus may persist up to 7 weeks in bodily fluids of recovered patients. Therefore, it is possible that transmission could sometimes occur far away with air travel, unknowingly.
(Sources: http://www.cdc.gov/vhf/ebola/, "Why Ebola is So Dangerous" - http://www.bbc.com/news/world-africa-26835233 , "Ebola Virus Disease"- http://www.who.int/mediacentre/factsheets/fs103/en/).
About NanoViricidesFDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.