Subsequent to this reporting period, the animal experiment portion of this study has been completed as of the end of January 2018. We have received initial verbal communications that indicate that our drug candidates were non-toxic in terms of behavioral and other observable signs during the study. We are awaiting a final report from the CRO, which is due shortly, and further discussion of next steps in the development of one of these drug candidates as the final clinical candidate for the treatment of shingles.
We have already begun to scale up production of these tested candidates to the larger amounts as estimated to be required for the ensuing Tox Package studies. We have estimated that approximately 500g of the candidate will be needed for such a study, based on discussions with BASi, Inc., IN, the service provider, and Biologics Consulting Group, VA, our regulatory consultants.
The market size for anti-shingles drugs is currently estimated to be in the range of several billions of dollars, even after a new shingles vaccine, Shingrix® (GlaxoSmithKline) has become available, based on a recent report by Dr. Myers of BioEnsemble, LLC, pharma industry consultants, commissioned by the Company.
More specifically, the report estimated that our anti-shingles drug could reach peak annual sales of as much as $2 Billion, depending upon the effectiveness determined in clinical trials, at an assumed 50% market penetration. Based on current pre-clinical data, we believe that there is a very strong probability that our shingles treatment would significantly minimize the shingles pain, accelerate healing, and minimize nerve damage, thereby minimizing the occurrence and severity of post-herpetic neuralgia (PHN). Our pre-clinical drug design efforts have been aimed at developing a treatment for shingles that would have pain reduction effects as well as healing effects on skin. If our anti-VZV drug candidate is as effective in human clinical studies as we see in the skin patch studies and in the cell culture studies, it would be reasonable to anticipate that the substantial reduction in viral load at the site of application would significantly minimize the shingles pain, accelerate healing, and minimize nerve damage, thereby minimizing the occurrence and severity of post-herpetic neuralgia (PHN). If this were borne out in clinical trials, the potential market could be closer to the $2 billion mark. However, initially, we do not plan on performing clinical trials aimed at proving PHN effectiveness, but rather, we plan on performing clinical trials based on VZV related biomarkers and clinical pathology, which we believe would be sufficient for a first indication for approval of the drug for treatment of shingles by the US FDA. We plan on performing observations regarding PHN in these clinical trials so that an informed PHN clinical trial may be performed later.
We have developed strong chemical manufacturing process controls that enable us to produce the backbone polymers with highly restricted and reproducible molecular size range. In fact, we have achieved highly reproducible and scalable processes that have yielded the same polymer molecular sizes across production scales from 10g to 500g. In other words, we are now able to control the length of the backbone polymer to within one monomer unit, irrespective of production scale (at least up to about 1 kg scale).
We believe that this is a remarkable and possibly unmatched achievement in the field of nanomedicines. We plan on scaling up the production of the polymer backbone “nanomicelle” to kilogram scales and do not anticipate any manufacturing constraints at present.
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