NanoViricides Reports Its Oral FluCide Anti-Influenza Drug Candidates Are Superior to Oral Oseltamivir (TamiFlu) in H1N1 Influenza Lethal Infection Model
WEST HAVEN, Conn.--(BUSINESS WIRE)--September 10, 2012 07:00 AM Eastern Daylight Time--NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that oral administration of its FluCide™ anti-influenza drug candidates provided clinically important disease protection in a lethal animal model of influenza infection. Moreover, the FluCide™ candidates were superior to oral oseltamivir (Tamiflu®, Roche), a current standard of care for influenza, in all parameters evaluated.
As compared to oseltamivir, the results clearly demonstrated that oral administration of two different FluCide drug candidates produced significantly greater reduction in the levels of influenza virus in the lungs of the infected mice. This reduction was accompanied by significant protection from the lung tissue inflammation and destruction that is believed to be important in the lethal pathogenesis in this highly lethal model of H1N1 Influenza virus infection. As a result of the reduction in lung viral load and protection against virus destruction of lung tissue, the oral FluCide drug candidates produced significant improvement in survival as compared to oseltamivir. The study was performed by KARD Scientific Inc. in the highly lethal influenza animal model as previously described.
The potential of an oral anti-influenza nanoviricide® drug has important implications for disease treatment. According to the CDC, influenza is a highly communicable acute respiratory disease that is considered to be one of the major infectious disease threats to the human population. During seasonal epidemics, 5-15% of the world population is typically infected (or about 300 million to 1 billion people infected), resulting in 3-5 million cases of severe illness affecting all age groups. Historically, in the USA alone, 5% to 20% of the population (approximately 40M people) come down with the flu annually, of which more than 200,000 persons are hospitalized from influenza-related complications, and approximately 36,000 people die from influenza-related causes even in a non-pandemic year. During the 1918 pandemic year, 675,000 Americans died from the flu. Most victims were healthy young adults and it was thought that majority of the deaths were from a phenomenon called “cytokine storm”, essentially an over-reaction of the immune system to the novel viral infection.
The company believes that an oral nanoviricide drug used either alone or in combination with other antiviral agents in humans with seasonal influenza could possibly reduce the number of cases of severe illness and of associated death. The Company believes that the effectiveness of such a regimen would be substantially superior to that with the current standard of care medicines for flu.
Of clinical importance, the WHO reports that the greatest risk to public health is the emergence of influenza A viruses in the general population for which immunity is lacking. Such novel viruses can spread rapidly and can result in a pandemic causing high levels of morbidity and mortality globally. This was witnessed recently with the rapidly spreading Influenza A/H1N1/2009 or so called “swine flu” pandemic outbreak.
The company believes that an oral nanoviricide drug would be of great use for the treatment of both seasonal and pandemic influenza.
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.
Amanda Schuon, 310-550-7200
Posted: September 2012