NanoViricides Accelerates its Herpes Drug Development Program

Aug 17, 2015, 07:00 ET from NanoViricides, Inc.

SHELTON, Conn., Aug. 17, 2015 /PRNewswire/ -- 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:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities.  Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

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SOURCE NanoViricides, Inc.



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