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Replies to post #115448 on NanoViricides Inc. (NNVC)
10/03/15 7:03 AM
NanoViricides Reports that the Dramatic Effects of Its Topical Anti-Herpes Treatment were Reproduced Once Again in an Animal Model in a Different Laboratory
SHELTON, CONNECTICUT -- Monday, August 10, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that the dramatic improvements in clinical symptoms associated with herpes simplex virus infection were reproduced in an animal model in a different laboratory. These studies were performed by TransPharm Preclinical Solutions ("TransPharm"), a pre-clinical services company in Jackson, MI.
All of the nanoviricides® tested improved clinical scores dramatically, with clinical presentation being arrested at redness or simply raised local lesions, and a complete absence of zosteriform spreading. All of the nanoviricides treated animals survived the lethal HSV-1 infection challenge for the duration of the study while untreated animals died towards the end of the study. These nanoviricides are designed as topical treatment for the breakout of herpes sores.
Some of the nanoviricides found effective in the previous study were tested in this study for the confirmation of efficacy in a dermal animal model in Balb-c mice using the same highly aggressive and neurotropic HSV-1 strain H129c, which was used previously.
The earlier studies were performed in the laboratory of Dr. Ken S. Rosenthal at Northeast Ohio Medical University where Dr. Rosenthal continued as a Professor Emeritus. He is a leading researcher in herpes virus anti-viral agents and vaccines.
In the previous study, two of the anti-Herpes nanoviricides® reduced the extent of disease (morbidity) and mortality of the HSV-1 infected animals that were treated. These nanoviricides also reduced virus production in cell culture. Importantly, topical dermal treatment with these nanoviricides led to almost complete (>85%) survival of the infected mice in this animal model whereas all untreated animals died of the disease. Further, these nanoviricides were superior to topical treatment with an acyclovir formulation employed as a positive control. The Company reported on these studies in April, 2015.
Professor Rosenthal consulted with NanoViricides and TransPharm for the establishment of the animal model for dermal HSV-1 infection using the HSV-1 strain H129c at the TransPharm laboratories.
Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.
About Dr. Rosenthal
Dr. Rosenthal is now Professor at the Roseman University of Health Sciences College of Medicine, NV. He continues as Professor Emeritus at Northeast Ohio Medical University (NEOMED), after retiring in December 2014. He is a leading researcher in the field of herpes viruses, antiviral drugs and vaccines. His research interests encompass several aspects of how herpes simplex virus (HSV) interacts with the host to cause disease. His research has addressed how HSV infects skin cells and examined viral properties that facilitate its virulence and ability to cause encephalitis. He is also researching how the human host immune response works against HSV for the development of protective and therapeutic vaccines.
About TransPharm
Transpharm Preclinical Solutions offer numerous types of studies for testing antimicrobials, antivirals, antifungals, antiparasitics, along with newer therapies using antibodies. TransPharm's scientists' skill set covers a broad range of Research and Development. This allows us to offer numerous services upon request. We have many strategic alliances along the Biotechnology Corridor which allows us to offer a wide variety of services.
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NanoViricides President Dr. Diwan Presented FluCide Data at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
WEST HAVEN, CONNECTICUT -- Monday, July 14, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).
Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company's first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that no significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
He also presented the data on NV-INF-2, the Company's current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.
The data indicate that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company's new facility capable of cGMP production of all of the Company's nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and "bird flu" such as H5N1.
The total market size addressed by the Company's current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
NanoViricides recently received an important international award, the "IAIR Award 2014 for Leadership in Nanomedicines in the North American Sector".
The Company currently has approximately $41 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials.
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Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
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Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
