NanoViricides Inc. (NNVC)

[changes_iv]

No effort whatsoever to quote/reference sources. Just use copy/paste.

What is a shame is an anonymous poster, full of opinions and he/she/they do not quote/reference their sources in the vast majority of their posts.

WEST HAVEN, CONNECTICUT -- August 20, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that anti-influenza drug candidates under its FluCide™ program, when given orally, were nearly as effective as when administered as IV injections. Two different anti-influenza drug candidates were tested in Oral vs. IV comparison, and both of them showed similar results that indicated strong oral effectiveness. The results clearly demonstrated that oral administration of both of these FluCide drug candidates resulted in substantially superior animal protection compared to oseltamivir (Tamiflu®), a standard of care for influenza at present. The studies involved the same highly lethal animal model the Company has continued to use for its influenza drug development program.
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Nanoviricides, Inc. has been working on the development of an orally available nanoviricide for several years now. The essential chemistries were finally worked out during the CMC (Chemistry, Manufacturing, and Controls) studies for our current FluCide™ drug candidate. An initial feasibility study to determine whether a nanoviricide anti-influenza drug candidate would work when administered orally was undertaken perviously and had shown positive indications. The Company continued further development and has now completed a definitive animal model study to determine whether one of the FluCide anti-influenza drug candidates was effective when administered orally. The study was performed by KARD Scientific Inc. in the highly lethal influenza animal model as previously described.
www.nanoviricides.com/press%20releases/2012/NanoViricides%20Reports%20that%20Oral%20Administration%20of%20FluCide%C2%AE%20Anti-Influenza%20Drug%20Candidates%20Led%20to%20Survival%20Improvements%20Comparable.html

Pre-clinical

In addition, drug development is required to establish the physicochemical properties of the NCE: its chemical makeup, stability, solubility. The process by which the chemical is made will be optimized so that from being made at the bench on a milligram scale by a medicinal chemist, it can be manufactured on the kilogram and then on the ton scale. It will be further examined for its suitability to be made into capsules, tablets, aerosol, intramuscular injectable, subcutaneous injectable, or intravenous formulations. Together these processes are known in preclinical development as Chemistry, Manufacturing and Control (CMC).
https://en.wikipedia.org/wiki/Drug_development

CMC Development Strategies for Small Pharma
James Bernstein Ph.D.

A significant trend in the pharmaceutical industry is the increasing proportion of early drug development carried out in smaller organizations, as opposed to the large vertically-integrated pharmaceutical companies. Most of these small organizations use contract development and manufacturing organizations (CDMOs) for the Chemistry, Manufacturing and Controls (CMC) aspects of development. In this model of drug development, a small innovator organization works in partnership with contract organizations for the early non-clinical, clinical, and CMC aspects of drug development.
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For small molecule new chemical entities (NCEs) in development, the value drivers are typically intellectual property, safety and efficacy. The CMC profile is often less important unless there is a major weakness in the molecule’s properties, e.g., very low solubility, poor stability, or inappropriate pharmacokinetic (PK) profile....

The Regulatory Framework

The regulatory structure around which smart CMC development must occur (in the current highest-value markets) principally comes from the United States Food and Drug Administration (FDA), the European Medicines Authority (EMA), and the International Conference on Harmonization (ICH). Both FDA and EMA recognize ICH standards, but the initial thrust of ICH standards was propelled towards marketed products. With the issuance of ICH Q7 in November 2000, ICH Quality Standards began to provide guidance to address CMC quality during the clinical development phases.

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Conclusion

The use of phase-appropriate CMC development strategies maximizes the limited resources available to small pharma. This is particularly important given the nature of the small pharma – CDMO relationship, and many small pharma use consultants with large pharma experience. Recognition of the value drivers for each new drug is one key to selecting the optimum development strategy, and these value drivers are dependent on the nature of the new active and new drug product. Attention to the value drivers for a new drug or drug product also creates the most attractive asset for potential partners. Scientifi c and regulatory strategies are available to the small pharma-CDMO partnership for more effi cient development of new drugs...
http://www.pharmoutsourcing.com/Featured-Articles/133695-CMC-Development-Strategies-for-Small-Pharma/

Biologics Consulting Group, Inc. (BCG) provides a full array of nonclinical pharmacology-toxicology consulting services that span the entire biologic/drug development process, from discovery through marketing application and approval.
http://www.biologicsconsulting.com/services/pharmacology-toxicology/

Nanda Subbarao, Ph.D. joined Biologics Consulting Group, Inc. as a Senior Consultant in June 2007.

Prior to BCG, worked for Sandoz (Novartis) in Dayton, NJ as Stability Manager where she led a group of chemists and sample coordinators/stability administrators for the Research and Commercial Stability Program. She was also responsible for stability storage and testing, sample flow, controlled drug substances and Reference Standards. She authored CMC analytical sections for more than 20 products. Some of her key achievements at Sandoz included the improvement of the Stability program cGMP compliance to current standards and the set-up of the sample flow system.
http://www.biologicsconsulting.com/staff-detail/nanda-subbarao/

We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.

http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html

[Seems to me they have completed the 1kg scale-up recipe and about 1kg is all we will need for clinical trials.]

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 [e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange

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NanoViricides Accelerates its Herpes Drug Development Program

SHELTON, CONNECTICUT -- Monday, August 17, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that it is accelerating its HerpeCide™ drug development program.

The Company will continue to develop its anti-herpesvirus franchise in parallel with the development of FluCide™, its anti-influenza drug candidate. The Company believes that drug development of the external treatments for the different herpes virus infections, such as topical skin creams or lotions for the treatment of herpes lesions, or shingles rash, as well as eye drops or gels for the treatment of herpes keratitis, are likely to require significantly less development work compared to the development of an injectable drug.

Biologics Consulting Group, Inc., a leading FDA regulatory consultant, is advising the Company on drug approval pathways and regulatory strategy.

Both the total amount of drug needed and the total amount of time needed for the pre-IND studies for any of the topical anti-herpes drug indications is expected to be much less than the corresponding projections for our injectable FluCide™ drug candidate for hospitalized patients with severe influenza.

The Company will continue the drug candidate and formulation optimization studies towards identification of the developmental drug candidates for IND applications. These studies will be performed to develop eye drops and gels for the treatment of HSV-1 herpes keratitis, as well as for skin cream and lotion formulations for the topical treatment of HSV-1 cold sores, HHV-3 shingles as well as HSV-2 genital lesions. The Company will then determine which indication it will follow first towards an IND. Unlike influenza, the herpesvirus efficacy studies are expected to need to be done with a very few HSV viral strains.

The Company has already successfully scaled up its drug production processes to 200g+ scale. The Company anticipates that this production scale may be sufficient for the tox package and other pre-IND studies for any one of the anti-herpes topical indications, whether for dermal application or for ocular therapy.

In addition, the Company is also continuing to scale up the production level of its different drug candidates to 1kg/batch, in order to enable production of the large amount of injectable FluCide needed for the Tox Package studies. The total amount needed for FluCide Tox Package studies was estimated at about 2~2.5kg, because of the extremely strong safety observed in preliminary safety toxicology studies in two different animal species.

The Company believes that it has sufficient financing available for IND filings and initial clinical trials of its drug candidates for at least two indications. The Company anticipates multiple indications to result from the HerpeCide and FluCide programs. The Company recently disclosed that its anti-herpes drug candidates have demonstrated excellent efficacy in repeated experiments in a dermal infection model of zosteriform herpes in mice in two different laboratories.

The market size for herpes simplex virus treatments is in excess of $2 billion annually. The Company believes that a drug that is superior to existing therapies could result in significantly expanded market size.

Existing therapies against HSV include acyclovir, famciclovir and chemically related drugs These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.

About Biologics Consulting Group
Biologics Consulting Group, Inc., a leading regulatory consulting firm in product development and regulatory strategy for biologics, drugs, and medical devices. For over 20 years, Biologics Consulting Group has supported clients in the preparation and review of CBER, CDER and CDRH regulatory applications, product development strategies, quality (or CMC) requirements, pre-clinical and clinical study designs, GLP/GCP/GMP audits, and strategic business planning.

The Biologics Consulting Group team is comprised of over 40 consultants with experience as FDA reviewers and senior supervisors, certified FDA inspectors, and senior leaders from the biotechnology industry.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Accelerates%20its%20Herpes%20Drug%20Development%20Program.html