NanoViricides Reports That Oral Administration of FluCide®, its Anti-Influenza Drug Candidate Was Effective In Animal Model
WEST HAVEN, CONNECTICUT -- August 13, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that an anti-influenza drug candidate under its FluCide™ program is effective when given orally. The Company has received information that a FluCide drug candidate designed for oral administration has shown very strong efficacy in corresponding animal studies. This information was received from the contract laboratory that performed the studies, namely, KARD Scientific, Inc. The studies involved the same highly lethal animal model the Company has continued to use for its influenza drug development program. The Company is awaiting data from the studies and intends to release additional information as the data are analyzed and studied.
“We are pleasantly surprised that the modifications that we have been studying for the development of a nanoviricide® that can be orally effective have indeed succeeded,” said Anil R. Diwan, PhD, President of the Company. “Molecules that nanomedicines are comprised of are notoriously difficult to develop into orally available drugs. This is indeed a coup for our nanomedicine technologies,” he further explained. ... Nanoviricides, Inc. has been working on the development of an orally available nanoviricide for several years now. The essential chemistries were finally worked out during the CMC (Chemistry, Manufacturing, and Controls) studies for our current FluCide™ drug candidate. An initial feasibility study to determine whether a nanoviricide anti-influenza drug candidate would work when administered orally was undertaken perviously and had shown positive indications. The Company continued further development and has now completed a definitive animal model study to determine whether one of the FluCide anti-influenza drug candidates was effective when administered orally. The study was conducted by KARD Scientific, Inc. Dr. Krishna Menon, President of KARD and consulting Regulatory Officer for NanoViricides, Inc., has advised the Company that some of the orally administered drug candidates provided by NanoViricides showed efficacy in combatting highly lethal influenza H1N1 infection in mice. http://www.nanoviricides.com/press%20releases/2012/NanoViricides%20Reports%20That%20Oral%20Administration%20of%20FluCide%C2%AE,%20its%20Anti-Influenza%20Drug%20Candidate%20Was%20Effective%20In%20Animal%20Model.html
[Going back in time to August 13, 2012, NanoViricides, Inc. was working with elements of Chemistry, Manufacture and Controls (CMC) for FluCide(TM), with the specialized equipment/instruments they had at the time. At that time, they may have been able to produce 100g, at most. Today, they have scaled up production at the West Haven lab to 200g. Is there any possibility that they are able to produce 200g batches, CMC (CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch) at the West Haven lab? Is the West Haven lab also a training center for new hires? ]
The Company has already successfully scaled up its drug production processes to 200g+ scale. The Company anticipates that this production scale may be sufficient for the tox package and other pre-IND studies for any one of the anti-herpes topical indications, whether for dermal application or for ocular therapy.
In addition, the Company is also continuing to scale up the production level of its different drug candidates to 1kg/batch, in order to enable production of the large amount of injectable FluCide needed for the Tox Package studies. The total amount needed for FluCide Tox Package studies was estimated at about 2~2.5kg, because of the extremely strong safety observed in preliminary safety toxicology studies in two different animal species.
The Company believes that it has sufficient financing available for IND filings and initial clinical trials of its drug candidates for at least two indications.
[Lets say we need (2)1kg batches (or 2kg) of FluCide(TM) for BASi. Can we say that if 200g more are needed, we can ship it not long after the 2kg of FluCide(TM) have been shipped to BASi?].
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.
In addition to top-down uniform particle size reduction to the nano-level, Microfluidics Reaction Technology (MRT) combines an impinging jet processor with application and process development to create nanoparticles bottom-up. Using continuous crystallization, chemical reactions and process intensification, MRT typically enables pharmaceutical, energy and chemical companies to achieve particle sizes impossible with any other method. Applications of MRT:
Technologies for nanofluidic systems: top-down vs. bottom-up--a review.
This paper gives an overview of the most commonly used techniques for nanostructuring and nanochannel fabrication employed in nanofluidics. They are divided into two large categories: top-down and bottom-up methods. Top-down methods are based on patterning on large scale while reducing the lateral dimensions to the nanoscale. Bottom-up methods arrange atoms and molecules in nanostructures. Here, we review the advantages and disadvantages of those methods and give some future perspectives. It is concluded that technology in the region of 1-10 nm is lacking and potentially can be covered by using the pulsed-laser deposition method as a controlled way for thin film deposition (thickness of a few nanometers) and further structuring by the top-down method. http://www.pubfacts.com/detail/15856084/Technologies-for-nanofluidic-systems-top-down-vs-bottom-up-a-review
Microfluidics Debuts Revolutionary Technology for Bottom-up Nanoparticle Creation at ACHEMA 2009 in Frankfurt, Germany Microfluidics Reaction Technology enables (MRT) continuous drug crystallization, efficient nanoencapsulation, chemical reactions, process intensification
Newton, Mass. - May 12, 2009 - Today at ACHEMA 2009 conference in Frankfurt, Germany (11-15 May), Microfluidics debuted its revolutionary Microfluidics Reaction Technology (MRT) to a global audience. Combining an impinging jet processor with expert process development in collaboration with the Microfluidics Technology Center, MRT enables continuous drug crystallization, efficient nanoencapsulation synthesis of fine chemicals through single or multiphase reactions, and process intensification.
The exclusive bottom-up technology has demonstrated the ability to produce high purity nanoparticles 40% smaller than any other method for a wide variety of drugs. MRT has received a Nano50™ Award for its contributions to nanotechnology innovations and improvements.
Microfluidics Chief Technology Officer, Thomai “Mimi” Panagiotou, Ph.D., will be at ACHEMA exhibit hall 5.0, booth F34, to meet individually with researchers from the biopharmaceutical, chemical, energy and other industries to discuss solutions for complex formulation challenges.
“Microfluidizer® processors are well-known around the world for their superior top-down particle size reduction capabilities, unique uniformity and repeatable results during scaleup,” said Dr. Panagiotou. “With the introduction of MRT, we are able to supplement and expand these leading product offerings to help customers achieve results that are simply not possible using any other technology. By leveraging the broad nanotechnology applications experience of research engineers in our lab, in conjunction with a specially configured processor, companies with demanding particle size and precise properties control requirements will finally be able to reach their goals.”
In addition to MRT, the Microfluidics team at ACHEMA will exhibit the popular flagship M-110P “Plug and Play” processor, which features continuous operation at pressures up to 2069 bar (30,000 psi) on a standard electrical outlet, with no need for compressed air or hydraulic cooling water. The company will also offer a complimentary sample processing in the Microfluidics Technology Center to qualified companies at ACHEMA.
Conference attendees at the Microfluidics exhibit booth will be eligible to win a complimentary Process Development Consulting engagement or customized application-specific training session.
