WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that it has shipped FluCide™ to BASi for the start of toxicology studies. NanoViricides has chosen BioAnalytical Systems Inc. Toxicology Services (“BASi”) of West Lafayette, Indiana to perform our safety/toxicology studies as needed for an IND submission of the Injectable FluCide drug candidate.
In other news, NanoViricides reported that the synthesis of its anti-Ebola second generation drug candidates has started. We anticipate being able to evaluate these against Ebola virus with certain of our previous collaborators. The contracts to enable such evaluation are currently in progress. The Company’s nanomedicine technology enables development of drugs that directly attack the virus, in a manner that a virus may not be able to overcome despite mutational changes. This is very important for the current epidemic-causing Ebola virus strain, which has been shown to be mutating rapidly.
Injectable FluCide was found to be extremely safe in mice in a preliminary safety study. This study showed no evidence of any adverse events even at the maximum tolerable dose level. No significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
With this information, and in consultation with BASi, we designed the safety/toxicology protocols for certain starting studies. We estimated that the total “Tox Package” studies would need as much as 2.5kg of the drug substance. Recently we broke up the study into parts and developed a starting study protocol that would require a 200g batch. Simultaneously, we have successfully scaled up our synthesis processes in the current Wood Street facilities, to be able to produce a 200g batch. The material we produced has gone through certain tests for its quality. We then prepared the samples as per the protocol design, and we have shipped them to BASi yesterday.
Injectable FluCide is our first drug candidate, designed to treat hospitalized patients with severe influenza. As noted above, it has been found to be extremely safe. In addition, it was found to be highly effective in combatting a highly lethal influenza A virus infection in mice. It was found to be highly effective against both Influenza A/H1N1 (same subtype as the 2009 pandemic), as well as Influenza A/H3N2 (another pandemic/epidemic strain).
We have previously published the pre-clinical data on the Company’s first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. FluCide has been built on the nanoviricides® technology platform. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4 that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
The data indicate that NV-INF-1 is a highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small-scale cGMP clinical drug manufacturing facility.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and “bird flu” such as H5N1.
The total market size addressed by the Company’s current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients with influenzas, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
The Company currently has approximately $48 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials.
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.
BASi (Bioanalytical Systems, Inc.) established in 1974 has headquarters in West Lafayette, Indiana. It provides contract research services and niche instrumentation, serving the life sciences industries, primarily in drug research and development. BASi was founded by a Purdue University chemistry professor and a group of his doctoral level students. Utilizing their abilities in electrochemistry they developed a line of products to detect trace chemicals in complex matrices. In the late 80’s, BASi entered the services business utilizing liquid chromatography and mass spectroscopy to provide analytical services to clients in their drug discovery efforts. BASi became a public company in 1997. Through a series of acquisitions in the 1990s and 2000s, BASi entered the EU market with a location in England, the preclinical toxicology market with a site near Evansville, Indiana for animal models and veterinary market.
