Viruses are constantly mutating, taking on new and daunting characteristics which make it more and more difficult for medical science to thwart them, especially when the only tools available are based on centuries old technology. The growing concern over the Zika virus, for instance, with nearly 4,500 confirmed cases in Brazil (http://dtn.fm/80KgF) and cases cropping up here in the U.S. (http://dtn.fm/iJe94), has lit a fire under the biotech sector, but a hoped-for vaccine could only be partially effective at fighting the spread. President Barack Obama recently asked Congress for $1.8 billion in emergency funding that would, in part, help expedite the development of a Zika vaccine. While Inovio Pharmaceuticals (NASDAQ: INO) has shown positive signs (http://dtn.fm/dngJ3) with its nascent vaccine, human trials won’t see the light of day until the end of this year.
The real kicker, though, is that, even if a vaccine is developed, it may be only marginally effective at stopping something like Zika, which is now even more readily asserted to be sexually transmissible (http://dtn.fm/7KlhH), directly linked to microcephaly (http://dtn.fm/0zI3B) in the newborn infants of infected women and even the paralyzing Guillain-Barre syndrome (http://dtn.fm/IP1kw). As is the case with seasonal influenza (flu) vaccines, overall efficacy is the real bottom line, and the CDC’s own numbers (http://dtn.fm/Czzi9) indicate that for the 2014 to 2015 season, adjusted overall efficacy was a mere 23 percent.
What we really need here is something new – a new and more agile weapon system based on truly 21st century technology. Development-stage NanoViricides (NYSE MKT: NNVC), with its nanotechnology-based biomimetic anti-viral medicines called nanoviricides® looks to be the answer to a question that, sadly, many in the medical community aren’t even asking yet. This technology could rightly be considered a “penicillin” for viruses due to the breadth of application, speed with which new indications can be developed, and show-stopping efficacy potential, and the company’s proprietary nanoviricides are also able to be administered orally (as well as through injection) in certain cases. Oral FluCide™, for instance, which NNVC proudly proclaims to be the first ever oral nanomedicine, has been shown to be substantially superior (http://dtn.fm/Ef7RD) to Roche’s (OTC: RHHBY) TamiFlu® (Oseltamivir) in animal models (Totally Lethal Infection Study) and exhibited broad-spectrum efficacy (Influenza A H1N1 and H3N2). Oral Flucide has also shown clear indication that a full clinical recovery is possible, even in high path, severe influenzas.
NanoViricides has received the IAIR AWARD as Best North American Company for Leadership in the Nanomedicine Sector from the prestigious IAIR® Group, the Milan-headquartered research institute and independent publishing house with major shareholders from Europe and Asia which has over a decade in global economy and sustainability publishing. This revolutionary company has developed a simple, yet powerful, antiviral platform technology employing the combination of a nanomicelle polymer that engulfs the target cell (http://dtn.fm/L2pcG), and mimic receptor proteins known as ligands, which lure the targeted virus to attack the nanoviricide. This platform’s key advantage of being able to trick the targeted virus into thinking the nanoviricide is a normal human cell via the ligands, which do not substantially change even when a virus mutates to a new form that may be resistant to other measures, is reinforced ably by NNVC’s proprietary method for quickly creating the unique ligands which are used. Because of this sweeping unification of efficacy and developmental capabilities, nanoviricides are not only suitable for attacking otherwise impossible to defeat viral agents on a commercial scale, they can also be rapidly developed in the field as a frontline measure to combat fast-mutating viruses using the company’s ADIF™ (Accurate-Drug-In-Field) technology.
Because the technique for field developing targeted therapeutics using ADIF involves the same tried and tested methodology as for any other nanoviricide – deriving the virus-binding ligand from the binding site of the virus cell surface receptor – the capacity to create an effective, targeted therapeutic in the midst of an outbreak, with only a small lab setup, is an advantage moving forward for NNVC that represents a tremendous value proposition to investors. Additionally, since the ADIF technology does not require any specific identification of the actual virus or difficult to obtain understanding of the specific molecular biology of the pathogen in question, a rapid-deployment nanoviricide, made using nanomicelles that have been stockpiled beforehand, effectively constitutes a field-ready smart weapon that is as adaptable as the most daunting viruses in existence, such as H5N1, SARS, and Ebola.
The combined market size for injectable and oral FluCide is likely over $30 billion, and because the company’s antivirals are so completely focused by design on the target virus, there is virtually no impact to the host, marking another clear advantage of this technology over antiquated vaccine technology. These nanoviricides can be created in weeks, instead of the years often required to develop a vaccine, and the company already has a robust pipeline of six potential blockbusters that have been tested in over 6,000 animals. FluCide has produced some amazing results thus far in animal model work, such as a greater than 1,000-fold lung viral load reduction, compared to less than two-fold in TamiFlu and the control group, or 100 percent survival rate at 22 plus days seen in the Totally Lethal Infection Study, compared to a 100 percent death rate after only eight days with extended TamiFlu treatment (100 percent death rate after five days with control group).
The combined estimated market size for the company’s antiviral eye drops designed to fight conjunctivitis/keratitis, its HerpeCide™ indication for shingles, as well as ocular and genital herpes (note that HSV-1 has also been linked to Alzheimer’s), and its DengueCide™ indication to combat Dengue arboviruses (West Nile, Yellow Fever, Japanese B Encephalitis), are in the neighborhood of $17 billion. The market size for NNVC’s HivCide™, which could be the first ever broad-spectrum weapon to stop the spread of HIV/AIDS, is estimated to be around $22 billion. The company’s DengueCide indication for Dengue fever and Dengue hemorrhagic fever is of particular note here, as that virus is in the same family as Zika.
The company already has multiple pre-clinical studies underway at various universities, HerpeCide is on track for human trials as early as this year, FluCide is slated for human trials shortly thereafter, and both the FDA and EMA have granted DengueCide orphan drug status. To understand the full story of NNVC, though, it is important to look at the company’s visionary management, including its chairman and president, Anil R. Diwan, PhD, as well as its CEO, Eugene Seymour MD, MPH, and CSO, Randall W. Barton, PhD.
Dr. Diwan, a prolific inventor and serial entrepreneur, pioneered polymeric micelle-based nanomedicine technologies with his invention of them back in 1991, but he is also the driving force behind keeping the company’s administrative and R&D costs at extremely low levels – despite the fact that the company has been aggressively expanding its pipeline each year. This administrative acumen is due in large part to his considerable wealth of experience, having founded nanomedicine and cell-targeted drug delivery, as well as small chemical, device technology and informatics-focused operations such as TheraCour Pharma and AllExcel, prior to co-founding NNVC. Dr. Diwan is a patent holder, with three more applications filed internationally resulting in numerous nation-level patents abroad. He has received numerous NIH small business innovation research grant awards and has several patent applications in various stages.
Dr. Seymour has a similarly eminent history of research and work under his belt, having cut his teeth back in the 1960’s in LA and Beverly Hills during the rise of the HIV/AIDS epidemic and having been tapped by the U.S. government to create a testing laboratory, as well as run a large-scale data generation operation examining HIV prevalence in LA’s Hispanic population. Dr. Seymour founded the company now known as Stat-Sure because of his foresight about the importance of prevention in lieu of a cure for HIV, and he went on to run a large non-profit after leaving the company in the late 1990’s, spearheading testing and training efforts in Asia and Africa before going on to be a UN Global Program on AIDS consultant who was deployed in several other countries. A holder of eight patents whose first love was chemistry and who initially trained to be a clinical investigator, Dr. Seymour got his master’s degree in the epidemiology of infectious diseases from UCLA before going on to do internal medicine work, and later becoming a member of the USC faculty as an Associate Professor. Dr. Seymour is also a Vietnam vet, having served in the U.S. Army Reserve Medical Corps during the Vietnam era, attaining the rank of Major.
Last, but certainly not least, is NNVC chief science officer Dr. Barton. Dr. Barton, former VP of drug discovery at personalized oncology innovators A&G Pharmaceuticals, has a rich history of drug discovery and development on both the small molecule and biological drug candidate ends of the spectrum, spanning multiple focus areas from virology and immunology to inflammation. Dr. Barton also possesses a great deal of experience in cardiovascular disease-related discovery and development from his collective pharmaceutical/biotech industry work, and he was a director for two decades at the U.S. pharmaceuticals division of German pharma giant Boehringer Ingelheim, where he helped do the pre-clinical development on the important HIV inhibitor drug Viramune (Nevirapine). This is a man with over 80 scientific publication to his name who has an abundance of academic and teaching experience behind him and who was the principal investigator in the development of five patents. Dr. Barton received his PhD in biochemistry from the University of Tennessee at Oak Ridge National Laboratory and was a faculty member at the University of Connecticut Medical School when he was awarded the NIH’s Career Development Award for his work doing research and education in the field of immunology.
Needless to say, NNVC has an esteemed, deep bench of upper management talent that has continued to produce bottom line results and mounting shareholder value in the form of its candidate portfolio. The immense potential of the company’s rapidly developing pipeline and nanoviricide/ADIF platform technologies themselves cannot really be properly estimated. Investors need to take a closer look here before the rest of the world realizes what NNVC has its hands on.
Get ahead of the curve, visit www.nanoviricides.com
