WEST HAVEN, CONNECTICUT -- September 04, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that anti-influenza drug candidates under its FluCide™ program, when given orally, led to strong antiviral antibody response. The antibody response with Oral administration was stronger than that with IV administration and was substantially greater than that observed with oseltamivir.
The results clearly demonstrated that oral administration of two different FluCide drug candidates resulted in substantially superior antibody response and 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.
Two different anti-influenza drug candidates were tested in Oral vs. IV comparison. One of the FluCide drug candidates, when administered orally, resulted in 1866±90 micro-g/ml-plasma of anti-influenza antibody, and 1258±59 when administered as IV injections. Another FluCide candidate, when given orally, resulted in 1491±37 ug/ml plasma of anti-influenza antibody, and 1151±53 when administered as IV injections. The untreated infected animals had 190±22 ug/ml antibody response, which was the weakest of all, as expected.
Of significance, oseltamivir (Tamiflu) resulted in only 950±64 ug/ml level of antibody response, which was far less than the two oral FluCide groups (p-value <0.0003), and also substantially less than the two IV FluCide groups (p-value <0.04). These p-values were determined for a comparison of FluCide groups against the oseltamivir group using the most stringent parameters, viz. two-tailed, paired, t-test. A smaller p-value indicates a greater confidence that the difference in observations cannot be a result of pure chance.
These data indicate that the antibody response was stronger when FluCide was given orally rather than as IV injection.
“Oral FluCide may be useful for protecting exposed individuals, such as health care workers and family members of a patient, based on the strong antiviral protection we have seen,” said Anil R. Diwan, PhD, Chairman and President of the Company.
“Prophylactic use would enable a much greater market size than just treatment for infected patients,” added Eugene Seymour, MD, MPH, CEO of the Company.
For IV administration, 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 (oral; 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. For the antibody response determination, mice were sampled in each group at the first day of observation of weight loss (i.e. 24h or so after weight loss set in). In this highly lethal model, weight loss has been a good indicator of progression of the infection towards death.
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.