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Replies to post #114895 on NanoViricides Inc. (NNVC)
09/02/15 1:14 PM
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
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Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
The c-GLP Tox Package study will be conducted by BAS incorporated (BASi), a well-known contract laboratory excelling in such studies. As we institute this study, we plan to use the same material for additional efficacy studies of our drug candidate against a number of different influenza virus types, subtypes, and strains. This is required to ascertain the broad-spectrum nature of the drug candidate. Our earlier studies have already demonstrated that this drug candidate is highly effective against both Type I and Type II Influenza A viruses in highly lethal animals studies. We believe that it should be capable of attacking almost any Influenza A virus, because it mimics the sialic acid receptor that all influenza viruses use to enter a host cell. After these studies are complete, and we have the reports in hand, we will be able to submit an "Investigational New Drug" application (IND) to the US FDA. An IND also requires at least two consistent cGMP batches of the drug to have been produced. However, certain international regulatory agencies do not require cGMP product, but rather cGMP-like product. The difference is subtle, but can make a difference of several months. We plan on taking advantage of this and try to request permission for human clinical trials abroad soon after we can make cGMP-compliant product in the new facility. The number of patients that need to be enrolled in a clinical trial depends upon how good the drug is. If the drug effect is very easily separated from the placebo, and more so, from the standard of care, then the trial would require fewer patients to reach the clinical end point of determining that the drug is indeed effective or superior, as the case may be. Therefore we believe, based on the very strong efficacy observed in our animal studies, that our influenza clinical trials will be short, and will be relatively inexpensive.
Facilities and Equipment. Although it generally is not necessary to fully qualify all equipment and validate all processes used in the manufacture of a product during its early development stages, it is important to document which equipment was utilized, why it was selected, and how it was used, cleaned, etc. If calibration of the equipment used to manufacture the product would typically be required in a GMP environment, a similar system is highly desirable at the research and development stage. In short, an intelligent evaluation of which pieces of equipment are critical to the operation should be made as soon as possible, and those critical pieces of equipment should be targeted to achieve compliance with "GMP-like" requirements by the time clinical-grade material is produced. Analogously, if the manufacturing process requires microbiologically-controlled facilities, it is prudent to measure and document the environmental control of these facilities to maintain product integrity and comparability.
Setting priorities for reaching compliance with GMP requirements is an integral part of product development planning. Once critical facilities and equipment have been identified, it is time to establish a schedule for generating compliance documentation. During product development, the move toward full compliance with Good Practice regulations is best regarded as a continuum, rather than a "now nothing, now everything" approach.
