WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced that its President, Dr. Anil R. Diwan, will present at the “Partnership Opportunities in Drug Delivery (PODD)” Conference being held at the Omni Parker Hotel in Boston, MA, today. Dr. Diwan is invited to present in the “Track 2: Large Molecules and Biologics Delivery”.
He will focus on the building-block-based tailor-made customization capabilities of the nanoviricide® platform technology that has enabled (1) rapid development of highly active drug candidates against many diseases, by using its direct-”address” targeting to the virus particle, and (2) rapid development of different formulations for administration. The Company has developed skin cream and lotion, eye drops, ophthalmic gels, and injectables based on this platform with very little formulation development needed.
In addition, he will present a summary of the nanoviricides® platform technology, the Company’s drug pipeline, its recent successes with animal studies for the Company’s influenza therapeutic FluCide™, and progress towards the initial FDA submission.
The Company also reports that its management team has no explanation for the recent drop in the Company’s stock price. Management believes that the Company is making significant progress in all of its initiatives. All of its drug programs are moving forward towards regulatory pathway satisfactorily. Also commenting on Dr. Anil Diwan’s recent sale of stock under the 10b(5) plan, the Company had recently announced that Dr. Diwan is using the funds from the sale, his personal savings, personal borrowings, and additional financing from other private investors that have previously invested in the Company, for the modern lab and cGMP facility initiative. The Company intends to lease this facility. Management had determined that this financing solution was the best available option in comparison to other available options. Management’s decision was based on minimizing capital expenditures for the Company and also minimizing dilution of the Company’s securities, thus benefiting our shareholders.
In particular, the Company reports that it is on course to submit its pre-IND application on the influenza clinical drug candidate to the US FDA as soon as the draft is finalized in consultation with its regulatory expert consultants including the Biologics Consulting Group (BCG), engaged by the Company to help in the regulatory submissions process.
The Company has recently announced that it is working on enabling cGMP (“current Good Manufacturing Practices”) capability for producing its drug candidates. cGMP manufactured materials will be required when the Company is ready to file an Investigational New Drug (IND) application to the US FDA.
The Company has chosen a clinical candidate, NV-INF-1, in its anti-influenza drug program (FluCide™) to develop for regulatory submissions both domestically and internationally. This is a single drug that the Company believes will be effective against most if not all Influenza A viruses. The Company believes that a single course therapy easily administered by a medical office is feasible for out-patients. The Company believes that in most instances no follow-on treatment would be necessary. This expectation is based on the following results from its animal studies: (1) the extremely high treatment effectiveness in inhibiting the cycle of infection, virus expansion and spread of infection and, (2) the significantly long lasting effects of the drug treatment after the drug is discontinued.
The Company has also recently announced significant successes in its anti-HIV drug program, viz. HIVCide™. The best HIVCide candidate in a recent SCID-hu Thy/Liv mouse model study showed effectiveness against HIV-1 similar to a three drug HAART (highly active anti-retroviral therapy) cocktail even when HIVCide was administered at a much lower total dosage. What is more significant, this nanoviricide drug candidate continued to work to suppress HIV viral load for at least 28 days beyond last drug administration. These data along with previous similar successes in anti-HIV drug development indicate that HIVCide may provide a “functional cure” of HIV/AIDS either alone or in combination with other drugs.
Further information on this meeting can be found at the website: http://www.theconferenceforum.org/PartnershipOpportunitiesInDrugDelivery-Overview.html.
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, Dengue fever, Hepatitis C, Rabies, 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.