NanoViricides, Inc. (the "Company") announced today that its President, Dr. Anil Diwan, will present an overview of the company at the 15th Annual BIO CEO and Investor Conference. The Conference is being held at the Waldorf-Astoria Hotel in New York City (http://www.bio.org/events/conferences/15th-annual-bio-ceo-investor-conference).
NanoViricides, Inc. presentation is scheduled for 11:30 am EST tomorrow, February 12th, in the Conrad Room.
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.
NanoViricides has also shown that its drug candidates against HIV/AIDS, even while being used as a single agent, had effectiveness equivalent to a triple drug HAART cocktail therapy in the standard humanized SCID-hu Thy/Liv mouse model. Further, viral load suppression continued, even after the nanoviricide drug treatment was stopped, for at least 4 weeks from last dosage, in contrast to current drugs which require daily therapy. This mouse model possesses human lymphocytes and results from this model are known to correlate well with human clinical studies. The Company believes that its HIVCide™ drug candidate will provide a “Functional Cure” of HIV/AIDS. A functional cure means that all anti-HIV and related medications can be discontinued until a new resurgence of the virus results from awakening of some latent reservoirs, which can take several months to several years.
NanoViricides has recently announced that it has raised $6M from private long-term investors (family offices) and a charitable foundation, resulting in approximately $19M cash in hand. The Company estimates that it has sufficient cash available to be able to conduct initial human clinical trials for its anti-influenza drug candidate.
NanoViricides is close to completing the design phase for its cGMP clinical trials drug substance production facility in Connecticut. The Clean Room suite for the production of clinical drug substance is being designed, fabricated, and installed by AES Clean Technology, Inc. As previously announced, privately held Inno-Haven, LLC, founded by Dr. Diwan, who is also the Company’s President and Chairman, has purchased an 18,000 sq. ft. building on approximately 4.3 acres in September 2011 with funding raised privately. The capital costs of the building and construction project are also being borne by Inno-Haven, LLC with funding from private sources that include loan arrangements. In order to minimize the capital costs, NanoViricides, Inc. intends to lease the completed facilities. A memorandum of understanding to that effect was signed today and requires a lease agreement to be signed before March 31, 2013. The renovation project is estimated to be completed in October, 2013, followed by occupancy and certifications by early 2014.
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.
In addition to Influenza and HIV, the Company has developed drug candidates against Dengue and Adenoviral Epidemic Kerato-Conjunctivitis (EKC) that have all shown extremely high efficacies in pre-clinical animal studies. The Company has also developed drug candidates against Herpes that have shown strong efficacies in pre-clinical studies. These additional four commercially important programs are at pre-clinical candidate optimization stage. The Company has several R&D programs against many other viruses including Ebola/Marburg and Rabies viruses.
The Company thus 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 one encountered in 2009-2010 (so called “swine flu”); 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.