WEST HAVEN, CONNECTICUT -- August 27, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that anti-influenza drug candidates under its FluCide™ program, when given orally, were nearly as effective as when administered as IV injections in terms of reduction in lung viral load. Two different anti-influenza drug candidates were tested in Oral vs. IV comparison, and both of them showed similar results that indicated strong oral effectiveness. The results clearly demonstrated that oral administration of both of these FluCide drug candidates resulted in substantially superior animal protection compared to oseltamivir (Tamiflu®), a standard of care for influenza at present. The studies involved the same highly lethal animal model the Company has continued to use for its influenza drug development program.
One of the FluCide drug candidates, when administered orally, resulted in 1.30 log reduction (or 20X reduction) in lung viral load and matched the viral load reduction on the same drug candidate given as an IV injection. Another drug candidate resulted in 1.23 log viral load reduction when given orally and 1.31 log viral load reduction when given as an injectable. In contrast, oseltamivir (Tamiflu®, given orally at 40mg/kg/d) resulted in only 0.6 log viral load reduction (or only 4X reduction) compared to negative controls. These were the results of lung viral load measured at 108 hours post-infection (hpi). Further, at 180 hpi, the lung viral load remained controlled at about the same level as at 108 hpi with the nanoviricide® drug candidates. In contrast, lung viral load in the oseltamivir treated mice increased to the same level as the negative control (infected untreated) animals prior to their death and the oseltamivir group exhibited a survival of only 182±4 hours.
The number of lung plaques and plaque areas (resulting from the influenza virus infection) also were consistent with the data from the lung viral load, and were minimal in the case of the nanoviricide drug candidates whether given as IV or orally. Oseltamivir treatment did not protect the lungs of infected animals anywhere close to the protection afforded by the FluCide drug candidates.
These data clearly demonstrated that both oral and IV treatment with nanoviricide drug candidates protected the lungs of the mice infected with influenza virus equally well. It is also clear that this lung protection was the result of the substantial decrease in the lung viral load. In addition, they show that FluCide drug candidates when given orally had substantial efficacy, almost matching the effectiveness of the injectable form given at 0.3X of the oral dosage level.
These data also clearly demonstrated that the FluCide drug candidates were substantially superior to oseltamivir or Tamiflu, the current standard of care for influenza infections.
The Company has previously said that the chemistries were modified in an attempt to make its drug candidates potentially available for oral administration. The Company had previously reported lung viral load reduction as high as 3 logs (1,000X) with its best injectable FluCide candidate in the same highly lethal animal model. The Company believes that oral administration is an important attribute and the trade-off in efficacy due to the change in chemistry is acceptable.
“We can easily increase the effectiveness of our drugs by increasing the oral dosage,” said Anil R. Diwan, PhD, noting further that, “ We have seen no adverse events in this study.”
Tail-vein injections were given at 48 hr intervals starting at 24 hrs post-infection. Oral FluCide was given once daily. Oseltamivir was given twice daily (total 40mg/kg per day). The total quantity of FluCide drug given orally was 3.33 times that of the drug given as injectable, to adjust for expected reduction in the amount of drug going into circulation.
The Company is awaiting additional data from the studies and intends to release information as the data are analyzed and studied.
Nanoviricides, Inc. has been working on the development of an orally available nanoviricide for several years now. The essential chemistries were finally worked out during the CMC (Chemistry, Manufacturing, and Controls) studies for our current FluCide™ drug candidate. An initial feasibility study to determine whether a nanoviricide anti-influenza drug candidate would work when administered orally was undertaken perviously and had shown positive indications. The Company continued further development and has now completed a definitive animal model study to determine whether one of the FluCide anti-influenza drug candidates was effective when administered orally. The study was performed by KARD Scientific Inc. in the highly lethal influenza animal model as previously described.