NanoViricides Inc. (NNVC)

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NanoViricides Signs a Non-Disclosure Agreement with the Lovelace Respiratory Research Institute for IND-enabling Efficacy Studies on FluCide® and for Testing its Novel Drug Candidates against the Highly Lethal MERS Human Coronavirus

WEST HAVEN, Conn.--(BUSINESS WIRE)--

NanoViricides, Inc. (OTC BB: NNVC) (the "Company") said it has signed a non-disclosure agreement (NDA) with the Lovelace Respiratory Research Institute (“LRRI”). The Company intends to enter into a Master Services Agreement with LRRI for the IND-enabling efficacy studies of both its broad-spectrum injectable and oral FluCide® drug candidates. These studies will employ multiple unrelated subtypes and strains of Influenza A, including the novel H7N9 strain, the subtype which is currently circulating in China. The Company has already shown that the injectable and oral FluCide drug candidates are substantially more effective than oseltamivir (Tamiflu®) in controlling influenza A virus infections in a highly lethal animal model using two unrelated subtypes of influenza A, namely H1N1 and H3N2. In addition to FluCide, LRRI will also be able to evaluate the Company’s anti-MERS drug candidates in cell culture and animal models when available. The NDA enables the scientists at the Company and LRRI to exchange confidential and proprietary information in preparation for the intended studies.

The injectable FluCide drug is intended for severely ill hospitalized patients while the follow-on oral drug is intended for use in out-patients. Following advice from the Company’s pre-IND meeting with the FDA, the Company intends to evaluate both drugs against multiple unrelated subtypes of influenza A in animal models and in cell culture studies.

H7N9 is a novel subtype currently circulating in China. Recent studies have indicated that it is a potential pandemic threat. H7N9 was found to be less sensitive to approved drugs than the H1N1/2009 pandemic strain. See New studies on H7N9 raise pandemic concerns | CIDRAP (http://www.cidrap.umn.edu/news-perspective/2013/07/new-studies-h7n9-raise-pandemic-concerns).

The Company has recently developed drug candidates for evaluation against the novel MERS h-CoV (“Middle East Respiratory Syndrome human Coronavirus”). The Obama administration has designated MERS as a potential threat to public health and national security, on June 4, 2013. Administration declares Mideast flu a potential public health emergency - The Hill's Healthwatch (http://thehill.com/blogs/healthwatch/public-global-health/303441-administration-declares-mideast-flu-a-potential-public-health-emergency). No drugs or vaccines are available against MERS h-CoV.

The Company has recently executed a NDA with the UK Public Health Agency that is intended to lead to a Master Service Agreement for the evaluation of FluCide against the novel A/H7N9 influenza strain as well as evaluation of the Company’s novel drug candidates against the newly emerging MERS human Coronavirus. The Company believes that independent testing of our drug candidates at these two sites should result in a dataset providing a high degree of confidence.

Efficacy

Definition: Whether a drug or other treatment works under the best possible conditions. In a research study about efficacy, the study participants are carefully selected, and the researchers can make sure the drug is taken properly and stored properly. The study participants may differ from other people in the general public who have the disease. A treatment that has efficacy under the best conditions may not work as well in a different group of people with the same disease.

Example: For example, a recent clinical trial compared people treated with insulin to people treated with oral medicine for diabetes. Only people with no other medical problems were enrolled in the study, and most were under age 65. The people treated with insulin had better improvement in their blood glucose than the people treated with oral medicines. This study is considered an efficacy study, because only younger people without any other health problems were included. Many people who have diabetes are over age 65 and have other problems such as heart disease. It is not known whether the same results would be found in these people.
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“The need for an effective, broad-spectrum, anti-influenza drug cannot be overstated,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “The current 2012 influenza season is already considered to be an epidemic. The current vaccine did not work well even though the same strain of H3N2 that is causing serious cases, was included in the vaccine mix. Vaccine effectiveness is only around 60%. In the previous 2009 epidemic, the virus swept the world long before a vaccine could become available. The 2009 virus was a novel strain, even though it was a subtype of H1N1. Vaccines are highly specific (narrow-spectrum) because they elicit antibodies in the human host, and antibodies are by nature very specific to their target.”

“We have clearly demonstrated that the design platform technology for nanoviricides allows development of powerful broad-spectrum antiviral drugs,” said Anil R. Diwan, PhD, President and Chairman of the Company, “We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.”

Binding to sialic acid on the cell surface is a completely conserved property of all influenza viruses. The avian influenza viruses tend to prefer binding to the a-2,3- variant of sialic acid, whereas those causing disease in humans tend to prefer binding to the a-2,6 variant. Pigs and some other species serve as “mixing species” where both the avian and mammalian viruses can grow, and further, avian viruses can mutate to mammalian viruses.

The Company has previously reported that its anti-influenza drug candidates have reduced viral loads from tens to hundreds of times lower levels than oseltamivir (Tamiflu®), depending upon the particulars of the experiment. The FluCide™ oral and injectable drug candidates also protected the lungs of the animals much better than did oseltamivir, indicating a clear benefit. The protection from influenza virus was clearly reflected in the strong increase in survival time in the FluCide-treated animals as compared to oseltamivir. Mice serve only as a “test tube” in these studies, since our drugs are designed to attack the virus particles directly. Thus these positive results in animal studies are expected to correlate well with the human clinical trials.

“We are rapidly advancing towards our goal of filing an IND with the FDA for Influenza based on the guidance we received in our previous pre-IND meeting with the FDA,” said Anil R. Diwan, President of the Company.