NanoViricides, Inc. (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.
About Lovelace Respiratory Research Institute:
The Lovelace Respiratory Research Institute (LRRI) is a private, biomedical research organization dedicated to improving public health through research on the prevention, treatment and cure of respiratory disease. LRRI is committed to curing respiratory diseases through research aimed at understanding their causes and biological mechanisms; assessing and eliminating exposures to respiratory health hazards; and developing improved therapeutics, vaccines, and diagnostics. LRRI is based in Albuquerque, New Mexico and employs 1,200 people including 150 Ph.D.’s.
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.