NanoViricides Retains a Consulting Firm to Expedite First FluCide Human Trials in Australia
WEST HAVEN, Conn.--(BUSINESS WIRE)--Jul 23, 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.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
Contact: NanoViricides, Inc.
Amanda Schuon, 310-550-7200
Posted: July 2012