WEST HAVEN, CONNECTICUT -- July 23rd, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials in Australia for Flucide™, the Company’s broad-spectrum anti-influenza drug. Australian Biologics will also facilitate clinical trial site(s) selection and development of the clinical trials agreements.
Dr. Jim Ackland, the Manager of Australian Biologics Pty, Ltd, has extensive experience in this field. Prior to becoming managing director of this company, he was Vice-President, West Coast and Asia Pacific operations for the Biologics Consulting Group, the Company’s US FDA regulatory affairs consulting group. In the 1990’s, he was the Head of Regulatory Affairs, Vaccines, for the CSL Group in Australia. The CSL Group is a global, specialty biopharmaceutical company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions.
“We are very pleased to engage Jim and his staff because of their extensive experience in both the regulatory and operational aspects of the clinical trials landscape in Australia,” stated Eugene Seymour, MD, MPH, Chief Executive Officer of the Company.
The Company believes that it will have the capability for producing drugs suitable for human clinical trials when renovation of the new facility in Shelton is completed. In parallel, the Company continues to pursue appropriate human clinical study pathways for its highly effective anti-influenza drug candidate, NV-INF-1, in the FluCide™ program. The Company has engaged Australian Biologics to study and develop a roadmap for conducting certain Phase 1 and Phase 2 human clinical studies in Australia.
NV-INF-1 has been shown to be highly effective in controlling influenza viral infection in lethal infection mouse model. Animals survived for full duration of the study (21 days) when treated with NV-INF-1 on alternate days. In contrast, oseltamivir-treated animals (40mg/kg given every day) survived for only 8 days. Untreated animals survive only 5 days in this highly lethal influenza infection model. The Company has previously reported that depending upon the treatment protocol, NV-INF-1 has shown viral load reduction of 1.3 logs to 3 logs in these various studies. In contrast, oseltamivir (Tamiflu®) treatment in the same studies has resulted in viral load reductions of only about 0.2 logs to 0.8 logs. Further, the lung damage caused by the influenza virus infection is also substantially reduced upon FluCide treatment as compared to oseltamivir treatment. Our data indicate that NV-INF-1 is significantly more effective compared to the standard-of-care drug for influenza, viz. oseltamivir.
The Company believes, based on our animal studies data, that NV-INF-1 may be the most effective anti-influenza drug currently in development.