WEST HAVEN, CONNECTICUT -- June 27th, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its President, Dr. Anil R. Diwan, will present an overview of the company at the OneMedForum-New York 2013 being held at the Metropolitan Club, New York.
NanoViricides, Inc. presentation is scheduled for 09:00AM EDT today, June 27th, and again for 02:30PM, EDT in the Morton Room.
NanoViricides will discuss its current corporate and financial state, the status of its new cGMP clinical batch manufacturing facility, and its broad drug pipeline. The presentation will focus on the Company’s Broad-Spectrum anti-Influenza FluCide™ Injectable and Oral drugs. Both of these drugs have been shown to be significantly more effective than Tamiflu®, the current standard of care for influenza, in highly lethal animal studies against two different unrelated influenza A types, namely H1N1, and H3N2.
The Company also believes that both of these FluCide drug candidates should be highly effective against the novel avian-origin H7N9 (2013) Influenza A virus that has caused several deaths in China, based on the known genetic makeup of this virus strain.
NanoViricides has completed the design phase for its cGMP clinical trials drug substance production facility in Connecticut. The Company believes that the construction project is on track for completion by the end of this year.
NanoViricides now has a fully independent board of directors, consisting of three independent directors and two executives. The independent directors are: Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology, Baylor College of Medicine; Mukund S. Kulkarni, MBA, PhD, Chancellor and Professor of Finance, Penn State University; and Mr. Stanley Glick, CPA, Chairman of our Audit Committee. In addition, Anil R. Diwan, PhD, Board Chairman and President, and Dr. Eugene Seymour, MD, MPH, CEO, remain executive board members. NanoViricides has also recently appointed Ms. Meeta R. Vyas, MBA (Finance), as the Chief Financial Officer. The Company has thus improved its Corporate Governance significantly.
The Company has raised $6M in a convertible debenture offering to three family offices and charitable foundation in February, 2013. The Company currently has approximately $16M cash and cash equivalent assets in hand. The Company believes that it has sufficient funds for two years of operations at the current rate of expenditures. The Company also believes, based on discussions with clinical studies contract research organizations, that it has sufficient funds in hand to be able to take at least one of its influenza drugs through initial human clinical trials.
The first ever orally active nanomedicine has been developed by NanoViricides, Inc. This oral anti-influenza drug candidate has shown very high bioavailability. NanoViricides also has an injectable anti-influenza drug in development towards clinical studies for serious cases of influenza. A pre-IND meeting with the FDA has helped the Company build its FluCide™ anti-influenza therapeutics program towards human clinical trials. Both the oral and injectable anti-influenza drug candidates have shown significant superiority over oseltamivir (Tamiflu®) in highly lethal animal model studies. Both drug candidates have shown strong activity against multiple, unrelated influenza types, suggesting that they indeed have broad-spectrum effectiveness against most if not all influenza viruses.
The Company is developing a broad range of anti-viral therapeutics against a number of different viruses. This is enabled by its novel nanoviricides® platform technology. A nanoviricide is designed to look like the cell surface to the virus, complete with the “landing sites” that the virus seeks on the cell surface to bind to the cell and thereafter enter the cell. These “landing sites” are designed into the nanoviricide by chemically incorporating “ligands” to which the virus is expected to bind. The Company strives to develop ligands that closely mimic the native landing sites of the virus, using in-silico modeling or “molecular docking” studies. Even as a virus mutates constantly, these landing sites to which the virus binds remain the same. The Company therefore believes that its drugs would be effective against a large range of strains and mutations of a given virus.
The Company has a broad drug pipeline, enabled by its novel, first-in-class, platform technology.
The Company is planning on two separate drugs against influenza: The injectable NV-INF-1, a high strength dosage form, for hospitalized patients with severe influenza; and the oral NV-INF-2, for out-patients with less severe influenza. Both drug candidates should be able to be used prophylactically to protect health care personnel and family members at high risk of contracting the virus.
NV-INF-1 promises to be a highly effective anti-influenza drug, based on the extremely high efficacy observed in animal studies, and the Company believes that it would receive rapid and widespread acceptance for the treatment of hospitalized patients with severe influenza. NV-INF-1 can also be used for out-patient treatment in a medical office, as well as for prophylactic treatment, and a single treatment is expected to be effective in such less severe cases of influenza.
A single course treatment for out-patients is a highly sought after goal in influenza therapeutics. During the 2009 H1N1 “swine flu” pandemic, approximately 61 million cases of out-patient influenza were estimated in the USA alone.
The Company’s anti-influenza clinical drug candidate is expected to be effective against a majority of strains and types of influenzas including novel epidemic influenza strains such as the current H7N9/2013 strains in China, and the one encountered in 2009-2010 (so called “swine flu”, H1N1/pdm09); seasonal flu such as H1N1, H3N2; highly pathogenic types such as H7N and H9N; as well as the highly lethal type, so called “bird flu” or H5N1. All influenza viruses use the same common receptor to bind to human cells. Therefore the Company believes that its influenza drug candidate should work against most of the influenza viruses.
The Company is also developing an oral anti-influenza drug, NV-INF-2, that is expected to become the drug of choice against influenza when it becomes available, opening up a large world-wide market with billions of cases per year.
In the USA alone, there are approximately 300,000 severe influenza cases that require hospitalization every year resulting in approximately 40,000 deaths. Expert physician advice suggests that the dosage form should be a high strength solution suitable for “piggy-back” incorporation into the standard IV fluid supplement system that is commonly used in hospitalized patients. Since current influenza treatments have limited effectiveness in these patients because of the severity of the infection and the stage of progression, there is a significant unmet medical need for the treatment of hospitalized influenza patients, which include immunocompromised patients.
The market size for anti-influenza drugs is currently estimated to be approximately $4-$7 billion worldwide. The Company believes that if its FluCide™ drugs become available, the influenza drug market size could expand substantially.
The Company is thus well poised for moving forward towards clinical studies of its anti-influenza drugs. The other drugs are expected to follow on as they progress further. The Company estimates that it is targeting a market size of over $40 Billion worldwide with its rich drug pipeline.