NanoViricides Management Reports that the Company is Fiscally Sound and Its Drug Development Programs are Progressing SuccessfullyPress Release
Source: NanoViricides, Inc.
On 7:00 am EDT, Monday October 26, 2009
WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), reports that the Company is well financed and its game changing anti-viral drug development programs are progressing successfully. As such, Management knows of no reason for the recent decline in stock price and associated volatility.
The Company announced that it has recently raised more than $4.3M in equity financing. The Company projects that this additional capital should be sufficient for at least 18 months of operations, or beyond December, 2010, at its current burn rate. In addition, as a result of strong and continued success in its anti-viral drug development programs, management believes that the Company has significantly improved access to the capital markets for additional funding that may be needed for financing IND studies.
“We now have four commercially important drugs in our pipeline, and sufficient funds to pursue further development,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “these drugs address a $40 billion market space.” The four commercially important drugs target HIV, all Influenzas, viral diseases of the external Eye, and Herpes Simplex viral infections including cold sores and genital herpes (HSV).
The Company has described the results from its preliminary anti-HIV animal model studies in a standard SCID-hu Thy/Liv mouse model in its annual report (filed on October 13, 2009). The anti-HIV nanoviricide drug candidates were found to be superior to a three-drug cocktail called HAART (for “highly active anti-retroviral therapy”) in all parameters tested. Significantly, the best nanoviricide drug candidate showed HIV-1 viral load reduction that was superior to that of animals treated with the oral HAART three-drug cocktail. This nanoviricide drug candidate also led to a significant increase in the proportion of human T lymphocytes that were positive for both CD4 and CD8 markers (CD4+CD8+ Double Positives or “DP”). This increase in DP human T cells in the nanoviricide treated mice was equal to or better than the oral HAART three-drug cocktail. Loss of human T cells caused by HIV was thus completely reversed by nanoviricide treatment.
Even more significantly the nanoviricide anti-HIV treatment was >25X (or >2,500%) more effective than the oral HAART treatment, on a drug load basis. The nanoviricide achieved these effects at a dosage level of only 150mg/kg, while the total HAART drug dosage was 4,200 mg/kg.
It is very important to note that no adverse events were observed in the nanoviricide treated mice, while the HAART-treated mice exhibited clinical signs of side effects.
The Company believes that HIVCide™ could very well result in a “Functional Cure” for HIV/AIDS, if these preliminary results are confirmed in further animal studies and in human clinical trials. In other words, HIVCide treatment could enable a HIV/AIDS patient to lead a completely disease-free life until an episode of hidden virus awakening from latent reservoirs occurs. HIV hides in immune cells forming latent reservoirs. It is widely believed in the scientific community that if these latent reservoirs could be wiped out then a complete cure for HIV/AIDS is possible.
The Company also detailed that it is now developing a single anti-influenza drug that is expected to be highly effective against all influenzas including swine flu (H1N1/2009), bird flu (H5N1), other pandemic capable highly pathogenic influenza viruses, as well as seasonal influenzas. The Company’s research over the past year enabled it to combine its separate drug programs for highly pathogenic influenzas, bird flu, and seasonal flu into one drug, FluCide™, to treat all influenza variants.
The Company has reported significant progress in its topical nanoviricide eye drops program. This drug is designed to treat most viral infections of the external eye, including adenoviral conjunctivitis (EKC) and herpes keratitis.
The Company also reported that it has successfully added a new anti-HSV drug program to its pipeline this year. The Company‘s topical anti-herpes drug candidate has already demonstrated greater than 10,000-fold (>99.99%, or >4 logs) reduction in virus quantity in cell culture models of HSV-1 infection. Animal model studies of topical and genital herpes are planned.
“We have already established a strong and robust drug pipeline,” said Anil R. Diwan, PhD, President of the Company, adding, “We now plan to focus on filing our first IND application as early as possible.”
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.
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.