Milestones in the Near Future for Advancing Our First Drug Candidate The path to the clinical trials for NanoViricides’ topical shingles preparation will include the following steps: -Selection of a final clinical drug candidate -Production of an adequate supply of the topical preparation for toxicology and initial human clinical trials -Safety/Toxicology studies -Filing of an IND in the US or equivalent application for beginning human clinical trials in another country -Regulatory Approval to begin human clinical trials -Initiation of Phase I Human Clinical safety trials to evaluate Safety -Successful Completion of Phase I human clinical trials -Initiation of Phase IIa Human Clinical trials to evaluate Effectiveness and Dosage -Successful Completion of Phase IIa human clinical trials
We have been diligently working towards completing a number of tasks needed to accomplish these steps particularly during the last year. We are on our way towards selecting a final clinical drug candidate. Our final drug candidates are currently undergoing cell culture testing at different facilities against VZV as well as HSV-1 and HSV-2. We have encouraging early cell culture data, which was expected based on previous successful studies. We are now awaiting completion of, and compilation of, the entire dataset from different collaborators and our own studies in cell culture. This will lead to selection of the best performing ligand in cell culture. We will then produce nanoviricides using this ligand and a short list of different nanomicelle polymer backbones to optimize effectiveness when applied onto skin. This work will be performed in Professor Moffat Lab at SUNY Upstate Medical Center. Successful completion of these human skin culture based studies should enable us to select a drug candidate for human clinical studies.
Simultaneously, we are already studying large scale synthesis of the nanomicelle polymer backbones as well as the short-listed ligands against HSV and VZV, which should provide us a head-start when we select the clinical candidate. We have scaled up many of the steps in the production to ~200g to ~500g scales. Our scale up lab and manufacturing facility are well equipped with reactor systems from as little as 500ml to as large as 30L already. We believe that approximately 200g production batch size should be sufficient for the Safety/Tox Study batch as well as for the Phase I and Phase II human clinical trials drug batches. We will need to successfully produce at least two batches that meet our quality assurance criteria before we can produce a clinical product batch.
I think that's the latest PUBLIC information. You knew the steps required, I'm sure. The "When", if provided, wouldn't have been worth the paper it was written on anyway.
BTW, am I correct in my understanding that the "nanomicelle polymer backbones" are part of the basic platform...that they are common from drug to drug and that the ligands will be the unique elements?
That's unclear. We might still get some more imaginary start dates for tox. Finish dates for tox are of course guaranteed imaginary if they are ever provided.
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