NanoViricides Inc. (NNVC)

[BonelessCat]

Diwan Presentaion to FDA 10/6/2006
Outline of Powerpoint Presentation

Title: NanoViricides, Polymeric Micelle-based flexible Specifically Targeted Drugs, Regulatory Implications for (a) IND-enabling Study, and (b) a Novel "War-like" Bio-threat Response Mechanism

Brief Description:
1. A nanoviricide is a polymeric single chemical chain with covalently attached ligands that specify the virus target. The antiviral spectrum of the drug is determined by the specificity of the set of ligands attached to the chain, in addition to other functionally important aspects inherent in the chemistries.

2. The following aspects distinguish these materials from usual drugs and biological materials seen by the FDA:
2a. As a polymer, it is not possible to manufacture a single molecular weight species. It is possible to operationally define a molecular weight distribution, such as "retained by membrane with NMWL xxx and passing through membrane with NMWL yyyy". The actual MW distribution can be characterized, but the result values are strongly dependent on the technique of measurement.
2b. These are not hard particle species. Therefore, SEM/TEM/AFM characterization is not possible.
2c. These are amphiphilic materials, limiting the use of many standard procedures.
2d. The polymer chemistries only enable "substantially complete" attachment of ligands, and this is essentially true for most of the chemistries used in the process.
2e. The material product can be defined operationally (i.e. in terms of processes used to make it), and further can be characterized in terms of average result values of chemistries (e.g. average MW, and MWD, average number of ligands per chain, etc.).

3. The biological efficacy of nanoviricides drugs may be several orders of magnitude better than that of usual chemical drugs (test case- influenza - preliminary studies). This in itself may limit the potential for mutant generation. There are also other key aspects of the design of nanoviricides that are expected to lead to minimizing mutant generation.

The above discussion relates to normal drug development of nanoviricides drugs. In addition:

4. "War-like" Bio-threat Response:
4a. In case of an unknown threat, it is possible to generate antibodies in the field, fragment them, and use well-specified fragments as ligands, attach them, and build a specific nanoviricide drug against the unknown, uncharacterized threat agent. Such scenario can occur in bioterrorism as well as in natural outbreaks (e.g. SARS).
4b. This is a different level of "Emergency Response", relating to scenarios where stockpiling is not possible because pathogen itself is unknown.
4c. This new scenario enabled by the naoviricides systems solution to biothreats may require additional regulatory perspectives. Such as (a) standard or EUA approval for the core nanomaterial, enabling its stockpiling, and (b) very limited, life-threatening-use approval for the nanoviricide generated in-field using the approach outlined in (4a) or a variant thereof such as using some small chemicals or peptides instead of antibody fragments.
4d. The purpose of such regulatory perspective would be to enable treatment within 2-3 weeks of threat event notification - or shorter if feasible - in order to limit casualties and morbidity and contain the threat at its source thus limiting the potential that it can convert into an epidemic or a pandemic.


http://www.fda.gov/nanotechnology/meetings/Diwan_files/Diwan%20NanoViricides26%20for%20%20FDA%20%202....