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.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.