SHELTON, Conn.—In what could become the first significant treatment for acute retinal necrosis (ARN), a recent study presented by NanoViricides Inc. ophthalmologist consultant Dr. Vivien Boniuk has reportedly shown that treating ARN with an experimental nanoviricide in a small animal model was “highly effective.”
This study will be repeated for verification, but if confirmed in both animals and humans, it could well represent a major breakthrough in the treatment of this highly devastating blinding disease, the company reports. ARN is a painful HSV-retinol infection that can cause blindness.
Borniuk presented the “Effect of NanoViricides Anti-Viral Agents in a Mouse Model of Acute Retinal Necrosis (ARN)” in a slide show at the Ocular Microbiology and Immunology Group (OMIG) of the American Academy of Ophthalmology.
“The main point of the presentation was to show the impressive effectiveness of our drug candidates in a well-established animal model of acute retinal necrosis, which is a severe and blinding disease difficult to treat in humans and with invariably poor outcomes,” Borniuk told DDNews.
“Our broad-spectrum herpes candidate is consistently effective in preclinical trials against VZV (shingles) HSV-2 (genital herpes) and HSV-1 (cold sores and ocular herpetic keratitis),” she says. “The important slides are those which show the mechanism of action of this platform, which is unique in that it actually kills the virus—not just inactivates it—but that it is safe and non-toxic, and that the platform can be used to develop viricides against any virus whose structure is known. The key slides are the data slides at the end, which showed by several parameters measured (including viral load and retention of normal structure of the retina), that our drug candidates were superior to the standard treatment currently used for therapy, which is the drug acyclovir in various forms.”
The company has developed a patented unique platform for actually killing viruses, Borniuk notes. There is no existing antiviral which does this. All of the current antivirals merely inhibit a metabolic pathway of the particular virus, slowing its growth.
“The nanoviricide has a core structure consisting of a micelle, to which is attached a ligand, the structure of which is computer generated to mimic the attachment point of the virus onto the cell,” Boniuk explains. “One of the first diagrams describing this, the nanomolecule of the NanoViricides drug, is very tiny, and several of the nanomolecules engulf the virus, breaking up its surface structure and rendering it inactive.”
“The particles break down into non-toxic organic substances which are easily removed by normal bodily digestive processes,” she adds. “The material is extremely safe and non-toxic and has been studied for the past 12 years in many animals and against many viruses (including influenza, HIV, dengue and others) with no toxic effects.”
Currently, the company “has developed a broad-spectrum anti-herpetic drug, which has been shown in tissue culture and in animal testing to be highly effective against several species of herpes, including VZV (varicella zoster virus, which causes shingles), HSV-2, which is the main causative agent of genital herpes, and HSV-1, which causes cold sores of the lip and most cases of viral herpetic keratitis of the cornea of the eye.
According to Borniuk, there are likely no more than 1,500 cases of ARN in the United States every year, and as such, “it is not practical at this point to shepherd this through the various clinical studies required by the FDA.” Instead, she tells DDNews, “We are focusing our efforts at this point on the HSV-2 which is much more frequent—present in about 50 million people in the U.S.—and the herpes keratitis and cold sores.”
It is significant to note that drugs used as the standard of care (acyclovir and foscarnet) showed no effect, whereas the intravitreal injection of the NanoViricides compound was highly effective in the treatment of viral-induced retinal disease and viral replication, Borniak concludes.
In other news, on Dec. 6, NanoViricides Inc. announced the start of an initial safety and pre-toxicology evaluation of its nanoviricides drug candidates targeted toward combating VZV. For reasons still unknown, one-third of Americans who have had chickenpox will develop shingles. There is no cure because the virus resides within the body for life.
Although a shingles vaccination is available if prescribed by a physician, it is not indicated for those who have already had shingles and therefore compromised their immune systems. The market size for anti-shingles drugs is currently estimated to be in the range of billions of dollars, according to the company.