NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), a development stage company that is creating special purpose nanomaterials for viral therap, reported today that testing of its topical eye drops drug candidate has begun at two different, independent facilities.
Testing of this broad-spectrum, topical, eye drug candidate by a major pharmaceutical company (“Party”) is now in progress. The Company had previously announced in March that it had signed a Material Transfer Agreement with this Party. In addition, the Company is also evaluating this drug candidate against herpes keratitis of the eye at Thevac, LLC, a spin-off of the Louisiana State University (Study Director, K. G. Kousoulas, PhD).
The testing at the two facilities will independently evaluate performance of this drug candidate against several types and strains of many different viruses that cause keratitis or conjunctivitis of the eye. Cell culture studies as well as animal studies with different animal models have been planned.
“Execution of the material transfer agreement (MTA) is a step towards a potential licensing agreement,” said Eugene Seymour, MD, MPH, CEO of Nanoviricides, Inc. The terms of the agreement do not allow the disclosure of the identity of the Party or the exact terms of the MTA.
HSV and some adenoviruses cause most of the cases of keratitis, a serious infection of the cornea. Importantly, HSV infection can lead to corneal scarring that may necessitate corneal transplantation. In addition, some adenoviruses cause a majority of conjunctivitis cases (“pink eye”). The remaining cases of conjunctivitis, caused by bacteria, are treatable with topical antibiotics. Currently, there are no effective treatments for viral diseases of the exterior portion of the eye.
The Company has already demonstrated strong efficacy against an adenovirus-caused external eye disease called epidemic kerato-conjunctivitis (EKC). Rapid clinical improvement in the treated animals was reported by independent researchers who tested the effects of the nanoviricides drug candidate against adenoviral EKC. Based on computer modeling, the Company believes that the broad-spectrum nature of the ligand used in this nanoviricide should enable it to be effective against HSV.
The total market for all forms of viral conjunctivitis/keratitis is estimated to be in the billions of dollars. The incidence of severe herpes (HSV) keratitis is estimated to be 250,000 cases per year in the USA. In Japan, where EKC is a reportable disease, it is estimated that there are at least one million cases per year. The number of cases of non-specific conjunctivitis (pink eye) is considered to be far greater, possibly into tens of millions in the US, and into hundreds of millions worldwide.