OneMedRadio: NanoViricides CEO Discusses U.S. Patent May 2012
NanoViricides, Inc. (OTC BB: NNVC) recently announced that a fundamental patent, on which the nanoviricidesR technology is based was issued in the USA on May 8, 2012. The issuance notification was received from the US Patents and Trademarks Office last week. ... The US Patent is granted for "Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic Polymers." The patent term is expected to last through October 1, 2026, including an anticipated extension, with the possibility of further extensions in compensation for time spent in clinical trials.
"We are very pleased with the validation of the novelty of our technologies," said Dr. Diwan, President and Chairman of NanoViricides, Inc., adding, "This patent establishes a fundamentally new direction in developing biomimetic approaches."
Commenting on the patent award, Dr. Eugene Seymour, MD, MPH, Chief Executive Officer of the company, stated, "We always knew that this is a ground-breaking technology. We believe, based on the tremendous effectiveness that our nanoviricides drugs have shown against a large number of viral diseases in several very stringent animal models, that this technology spells a fundamental change in how medicines will be developed in the future. For example, our anti-influenza clinical candidate, FlucideT, was developed using the nanoviricideR technology, and has exhibited surprisingly high levels of effectiveness in animal studies, far surpassing the existing drugs. Our expectation that FluCide will work well in humans is based upon the results of these animal studies that indicate (1) 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 even after the drug is discontinued."
Brett Johnson: So what do you see is the principal applications of this technology? Dr. Eugene Seymour: Well, let's look at some of the more common viral diseases that have market shares in the billions. Influenza and our nanoviricide for influenza will destroy any influenza A and we've tested many, many different ones. We even tested H5N1 the bird flu virus. We tested that in Vietnam when they were having an outbreak some years ago. HIV and we reported some very good results in animals with HIV. In fact, we reported a functional cure on two separate occasions, which means that we reduced the level of virus in the body to such a low level that you allow the antibody producing cells to recover and control the remainder of the cells and that way people can live a normal life often as we anticipate with only five days of treatment and maybe an additional treatment every three months for the next year and then after that nothing. They're not contagious because the amount of virus that they have in the body is really so dramatically reduced. Then there's herpes of the genitals, herpes of the eye.
BJ: And this technology is effective on all these viruses? ES: Yeah. All we do is change the receptor molecule. It's a plug and play. It's a Lego system.
A nanoviricide is created by chemically attaching a virus-binding ligand, derived from the binding site of the virus on its cell surface receptor, to a nanomicelle flexible polymer. This binding site does not change significantly when a virus mutates
Tailor-made design and selection of (1) the virus-binding ligand; and (2) the backbone "nanomicelle", separately, allows us to rapidly optimize drug candidates (a) against a number of viruses; (b) for desired pharmacokinetic characteristics (e.g. sustained effect); and (c) for different routes of administration. This versatility is unmatched in the Industry. http://www.nanoviricides.com/technology.html
NanoViricides Reports that it is Evaluating Purchase of the New Facility and cGMP Pilot Production Plant instead of a Lease "By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success," said Eugene Seymour, MD, MPH, adding, "NanoViricides continued to search for available contract manufacturing capability even after Diwan's purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property." http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20that%20it%20is%20Evaluating%20Purchase%20of%20the%20New%20Facility%20and%20cGMP%20Pilot%20Production%20Plant%20instead%20of%20a%20Lease.html
NanoViricides, Inc. Completes Purchase of cGMP-compliant Pilot Production Facility
NanoViricides now intends to move its operations to the new facility in a phased manner in order to minimize any potential impact on ongoing projects. The Company expects to manufacture its drug candidates for human clinical trials at the new facility. The Company further reports that all of its drug development programs are progressing satisfactorily. ... The 18,000 sqft building at 1 Controls Drive, Shelton, CT, was completely renovated in order to build a modern, state-of-the-art c-GMP-compliant manufacturing facility for the production of clinical scale quantities of a wide variety of injectable nanomedicines drug substances and drug products, modern nanomedicines research and development facilities, as well as an on-site state-of-the-art nanomedicines analysis and characterization facility. The new facility comprises a small office space, R&D Chemistry Labs, R&D Biology Labs, R&D Analytical Lab and cGMP supporting Analytical Lab, cGMP-compliant raw materials handling and dispensing area, and c-GMP compliant Clean Room Suites for nanomedicines production and product packaging processes. All of the R&D labs employ class 100,000 or cleaner air systems. The clean room suites comprise class 10,000 air quality areas as well as class 1,000 and the ultra-clean class 100 air quality areas (the class specifies the number of particles per 1,000 liters of air). This allows production and handling of nanomedicines with minimal risk of entraining foreign particles. All of the R&D labs employ deionized water. For critical processes, WFI-quality water is also produced on site in quantities needed to support the production scale (WFI = water for injection, comprises a specification of water quality that specifies minimal endotoxins and maximum sterility). http://www.prnewswire.com/news-releases/nanoviricides-inc-completes-purchase-of-cgmp-compliant-pilot-production-facility-300017051.html NanoViricides : Reports that the FluCideR Candidate was found to be Very Safe in cGLP-like Safety and Toxicology Study in Rats Performed by BASi
WEST HAVEN, Conn., Jan. 23, 2015 /PRNewswire/ -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, reported a good safety profile of an optimized FluCideR drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline. ... No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed.
There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.
The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.
These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company's positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.
This study was developed in collaboration with BASi and conducted by BASi in a cGLP-like fashion in order to understand the safety parameters of FluCide intravenous dosing.
The next phase of the toxicology package studies will involve larger animals, and will require much larger quantities of the drug candidate. The Company is in the process of commissioning operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the scale up studies needed for making the large quantities of materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. http://www.4-traders.com/NANOVIRICIDES-INC-15311537/news/NanoViricides--Reports-that-the-FluCide-Candidate-was-found-to-be-Very-Safe-in-cGLP-like-Safety-an-19751467/
[About two years ago Jan Torgersen was speaking about a race to the bottom - nano 3d printing. Jan Torgersen started his phd work at the Insitute of Materials Science and Technology. Jan's field is Additive Manufacturing Technologies; the technology involved in 3D printing. He developed a new printer that is able to produce nano-scaled objects suitable for numerous applications in photonics, surface modifications and biomedical engineering. This printer is currently the fastest of its kind and brings the technology closer to industrial applications. How it works got illustrated recently by a video that went around the world, showing the construction of a racing car model in the scale of a human hair. My question: Who makes the bioreactor(s) employed by NanoViricides, Inc. to assemble "LEGO-like" nanoviricides(TM) (PEG + virus-targeting ligands)?]
Breakthrough Molecular 3D Printer Can Print Billions of Possible Compounds
by Brian Krassenstein · March 13, 2015 ... Burke and his team have created a machine which could be described as a major breakthrough in the field of chemistry, a 'molecule-making machine'. Sound futuristic? Well that's because it is. The machine, which was described in a paper featured in today's issue of Science, could best be described as a 3D printer for chemicals.
"We wanted to take a very complex process, chemical synthesis, and make it simple," explained Burke. "Simplicity enables automation, which, in turn, can broadly enable discovery and bring the substantial power of making molecules to nonspecialists."
... The way the machine works is quite extraordinary. It is able to break down very complex molecules into their basic chemical building blocks. To put things into perspective, imagine each chemical building block as a different LEGO brick. They all share the same connectors, but may be totally different from one another. The machine is able to use a catch-and-release method to automate the process of connecting these building blocks together, one brick at a time, while releasing the byproducts of each chemical reaction. It was this technique of releasing the unwanted byproducts which made this breakthrough a reality. Using this process the machine can utilize over 200 different building blocks along with thousands of other molecules to 'print' billions of different organic compounds, many of which make up 14 classes of small molecules, including the ratanhine molecule family. Also, according to Burke, it can even synthesize chemicals which were never before created by human beings.
"The vision for the future is that anyone who needs a specific small molecule can essentially print it out from their computer," explained Burke. "We are really excited about the immediate impacts that this will have on drug discovery."
A new company, co-founded by Burke, called REVOLUTION Medicines, Inc. has already licensed the technology and is investing heavily in developing next generation molecule-making machines which will be much more powerful and easier to scale[color=red][/color]. If things go as planned, these machines have the potential to do to chemistry what 3D printing has done to engineering; making it fast, less complicated and accessible to pretty much anyone. In fact, the company already is working to improve upon an anti-fungal compound known as Amphotericin B, which is found in b1nature and used to treat patients with life-threatening fungal infections.
"Perhaps most exciting, this work has opened up an actionable road map to a general and automated way to make most small molecules," stated Burke. "If that goal can be realized, it will help shift the bottleneck from synthesis to function and bring the power of making small molecules to nonspecialists..A 3D printer for molecules could allow us to harness all the creativity, innovation, and outside-the-box thinking that comes when non-experts start to use technology that used to only be in the hands of a select few."
The potential this new machine could have for new rapid drug discovery as well as new chemically spawned technologies could be staggering. Imagine a website like Thingiverse, where instead of open sourcing 3D design files for printing, you could open source medications and other chemicals. That's where the future may be headed! http://3dprint.com/50777/molecular-3d-printer/
NanoViricides Provides an Update on Its Progress over the Last Quarter
WEST HAVEN, CONNECTICUT -- Monday, April 6, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports on the Company's progress in the recent quarter.
Ebola Using NanoViricides's rapid design platform, it took only 4 months from design to synthesis of the multiple EbolaCide drug candidates needed for study. In late January, these novel anti-Ebola drug candidates were sent to our collaborating BSL-4 facility for initial testing. Our drug candidates were found to be broad-spectrum, in that they were equally effective against Ebola virus as well as Marburg viruses. This is unlike the antibody-based, siRNA-based and antisense-based anti-Ebola therapeutics currently being advanced, which only work against specific strains with a very narrow and selective spectrum of activity. Broad-spectrum activity of our drug candidates is a very important and valuable characteristic, as it indicates that mutations of the virus in the field are unlikely to cause escape of the virus from our final EbolaCideT drug. We believe that with the new insight we have gained, and with our experience from earlier studies, we can continue to optimize our multiple drug candidates before another Ebola epidemic strikes. The recent outbreak in Africa, though now waning, has unequivocally demonstrated the need for an effective, broad-spectrum, anti-Ebola therapeutic in order to control any further outbreaks.
Herpes The Company has also been working on its anti-herpes drug candidates. Our anti-HSV (herpes simplex virus) drug candidates have previously shown strong activity with >99.9% inhibition when tested against two significantly different strains of HSV-1 in cell culture studies. The anti-HSV drug candidates have since been further modified to improve effectiveness in dermal application in a small animal dermal HSV-1 infection model. The cell culture and animal studies have been completed as of today and we are now awaiting the reports. These studies were performed in Professor Ken Rosenthal's laboratory at the Northeast Ohio Medical University.
We anticipate that these broad-spectrum anti-HSV drug candidates would be effective against oral and skin lesions caused by HSV-1 strains, genital lesions caused by HSV-2 strains, herpes keratitis (a potentially blinding eye disease caused by HSV-1), and most probably against shingles as well. Shingles or zoster is a wide-spread skin disease that occurs from re-awakening of the chickenpox virus (namely, human herpesvirus-3 aka varicella zoster virus). VZV, like HSV-1 and HSV-2 is in the alpha-herpesvirus family. There are one million cases of shingles in the US yearly. There are approximately 25 million cases of genital herpes in the US on an annual basis.
Influenza We are currently working to increase the production of FluCideT, our anti-influenza drug candidate. FluCide has been designed for use in hospitalized patients with complicated influenza. FluCide was found to be extremely safe in preliminary toxicology studies in mice and rats. As a result of the extreme safety finding, it was estimated that about 2.5kg of drug substance would be needed for the complete large animal toxicology studies. These studies are needed for filing an Investigational New Drug Application (IND). In mice, no adverse events were observed even at doses as high as 480 mg/kg/d repeated on five days (a total of 2,400 mg/kg), when given intraperitoneally. Similar strong safety was also observed in the initial part of the formal toxicology study in rats. In rats, no adverse events were observed with doses as high as 300mg/kg/d given by rapid intravenous infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are in the process of producing a total of 2.5kg of FluCide for the final large animal toxicology studies. Our toxicology studies are being performed by BioAnalytical Systems, Inc. (BASI) of Indiana (BASI).
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
[Are we using one bioreactor or are we having installed many small bioreactors that work in parallel, simultaneously, for a combined production of optimized large quantities of FluCide? NanoViricides, Inc. technology is being found effective on all viruses we've tested, so far. All our small company does is change the receptor molecule. It's a plug and play. It's a Lego-like system.
How does that molecular 3D printer work? --- The way the machine works is quite extraordinary. It is able to break down very complex molecules into their basic chemical building blocks. To put things into perspective, imagine each chemical building block as a different LEGO brick. We definitely speak the same "LEGO-like" language.]
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, Nanoviricides, Inc.
"It is not easy to convey, unless one has experienced it, the dramatic feeling of sudden enlightenment that floods the mind when the right idea finally clicks into place. One immediately sees how many previously puzzling facts are neatly explained by the new hypothesis. One could kick oneself for not having the idea earlier, it now seems so obvious. Yet before, everything was in a fog."
