SHELTON, CONNECTICUT -- June 20, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a global leader in nanomedicines that is developing biomimetic anti-viral drugs reports that its herpesvirus drug development programs are progressing satisfactorily.
The Company has previously said that in its HerpeCide™ program, it is currently developing drugs against four different herpesviral disease indications, namely, (i) "Cold sores" caused by Herpes Simplex Virus-1 (HSV-1), (ii) Shingles caused by re-awakening of the chickenpox virus (Varicella Zoster Virus, VZV), (iii) Ocular herpes keratitis which is caused by HSV-1 or HSV-2, and (iv) "Genital ulcers" caused by HSV-2. All of these drugs are being developed as topical treatments.
The Company has previously identified a drug candidate that demonstrated substantially complete protection to mice lethally infected with HSV-1 H129 neurotropic strain that produces zosteriform disease in the animals. while in the same study, only 58% of acyclovir treated mice survived. The study was repeated at a different facility with similar results.
Since then the Company has undertaken further full fledged drug candidate optimization program which is anticipated to result in a candidates superior to the one in hand. As part of this program, the Company has developed novel, broad-spectrum, herpesvirus binding ligands using molecular modeling studies that exhibit substantially better binding scores compared to the ligand employed in the prior animal studies. Several of these ligands were short-listed and were synthesized at small scale to enable cell culture based antiviral evaluation against various herpesviruses.
The Company has also developed different forms of the backbone "nanomicelle" polymeric material to which we attach the antiviral ligand to make the complete antiviral nanomedicine. These forms have been designed to optimize uptake across the dermal barrier. A few of these polymers have already been synthesized in quantities sufficient to support animal studies of the HerpeCide candidates. Importantly, the production processes are being optimized as they are implemented. We believe that substantially optimizing these processes at the scale we expect to require for human clinical studies will save us time in making the clinical drug substance batches.
Preliminary cell culture-based antiviral effectiveness and toxicity testing is being undertaken at different facilities. A further round of cell culture testing for more accurate, detailed evaluation will be required before commissioning animal studies. These evaluations are needed for reducing the large library of candidates at the current drug candidate optimization stage to just a few candidates going into pre-clinical animal studies.
We are now in the process of making larger quantities of the anti-herpesvirus ligands for making nanoviricides for the pre-clinical animal testing programs to determine the best drug candidate for each of the four drug indications described above.
The Company has set up several antiviral cell culture based assays in house, at our new Shelton campus, in our virology suites certified at Biological Safety Level 2. In particular, the VZV antiviral drug development assays have now been standardized. In addition, HSV-1 and HSV-2 assay development work has been commissioned. Additionally, anti-HSV cell culture testing is being conducted at the Collaborative Ophthalmic Research Laboratories, CORL, of the University of Wisconsin. We also have collaborations with the University of Pittsburgh and the Baylor University for anti-HSV studies in eye disease indications. We intend to perform animal studies against the various herpesviruses in the relevant models for the four different drug indications cited earlier, at these three facilities as well as at TransPharm Preclinical Solutions, a contract research organization.
"We are very happy with our progress in the four HerpeCide drug development programs, and especially in the VZV program," said Eugene Seymour, MD, MPH, CEO of the Company, adding, "We are working as hard as we can and as fast as we can to get at least one, and possibly more than one, of these programs into human clinical trials in a relatively short timeframe. However, we cannot provide timelines because of the extreme dependence on external testing of our drug candidates and the related inefficiencies."About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.