NanoViricides Reports Its First Drug Candidate is on Track with GLP Safety/Toxicology Studies toward Human Clinical Trials
SHELTON, Conn., Aug. 5, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a leader in developing novel nanomedicines to treat viral diseases, based on the nanoviricdes® platform, announces that its first drug candidate, NV-HHV-101, is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. The Company reports that NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment.
The in-life stage of the first part of the GLP studies is complete, allowing assessment of clinical observations. The Company is waiting on the full histology studies to assess the effects on all primary organs. The study was conducted by BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies.
The first of these GLP studies, a GLP safety and tolerability study following dermal treatment, was conducted using minipigs, who received twice daily skin treatment for 28 days, at different dosage levels. The animals were evaluated daily for general signs of toxicity including body weight, detailed clinical physical observations as well as the specific evaluation of the skin treatment areas. Topical treatment of the skin at all doses was well tolerated in all animals and all measured parameters remained within normal range in the study.
The Company has previously found that NV-HHV-101 was safe and well tolerated in non-GLP safety/toxicology studies. The GLP studies are an expanded version of the non-GLP studies, with extended treatment, larger number of subjects, and stringent operational requirements as specified by the current Good Laboratory Practices guidelines for such studies.
Additional studies required for the Safety and Toxicology datasets for filing an IND are in progress.
The Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication, assuming that these studies are successful. The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
The GLP Safety/Toxicology studies phase began in June, 2019. The Company produced approximately 1kg of the NV-HHV-101 drug substance under strict quality controlled operations at its cGMP-capable manufacturing facility in Shelton, CT, for these studies.
NanoViricides is a unique company in that it has its own cGMP manufacturing capability for its complex nanomedicine drugs. This has enabled the Company to minimize production time to a safety/tox study quality drug product, as well as to minimize the associated costs. The Company has the capacity and intends to perform cGMP manufacture of its drug candidates as needed for human clinical trials at this facility, allowing rapid progress to clinical trials. We intend to file an IND with the US FDA soon after completion of the GLP Safety/Toxicology studies and receipt of the final reports from the performing agencies.
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's lead drug candidate is NV-HHV-101, formulated as a skin cream for topical treatment of shingles rash (caused by VZV). The Company is also evaluating this broad-spectrum drug candidate and its variants for topical treatment of HSV-1 "cold sores" and HSV-2 "genital ulcers". 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. Please refer to our quarterly and annual reports for additional information. 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 preclinical 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.
FDA refers to US Food and Drug Administration. IND refers to investigational new drug application.
SOURCE NanoViricides, Inc.
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