Under the Symbol:
NanoViricides Has Initiated Bio-analytical Studies as Part of IND-Enabling Safety and Toxicology Studies of Lead Candidate NV-HHV-101
Wednesday, October 9, 2019 7:30 AM
SHELTON, CT / ACCESSWIRE / October 9, 2019 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a leader in nanomedicines with novel platform technology to treat difficult and life-threatening viral diseases, announces that it has initiated bio-analytical studies as part of the required IND-enabling preclinical safety and toxicology studies of NV-HHV-101, moving towards human clinical trials.
The Company has contracted NorthEast BioLab, Hamden CT, to conduct the bio-analytical studies and facilitate the toxicokinetic analyses. These studies and analyses are part of the required general safety and toxicology studies that will go into an Investigational New Drug (IND) Application to the US FDA.
NorthEast BioLab has already performed the bio-analytical assay development and validation and is in the process of determining the concentrations of NV-HHV-101 in blood samples from the general safety and toxicology studies that are required for IND.
The Company has previously reported on the early results from the GLP safety and toxicology studies that were performed by BioAnalytical Systems, Inc., Evansville, IN ("BASi"). The first of these studies, a GLP safety and tolerability study following dermal treatment, was conducted using miniature pigs, called minipigs, that received twice daily skin treatment of NV-HHV-101 for 28 days. A second GLP study was conducted in rats treated with NV-HHV-101 for 28 days by subcutaneous administration to ensure systemic exposure and to determine effects of such systemic exposure. NV-HHV-101 is designed for administration as a dermal topical cream.
As previously reported, treatment of minipigs and rats with NV-HHV-101 for 28 days has been shown to be safe for the animals and well tolerated based on the in-life observations. The Company is awaiting more detailed clinical and histological reports from these GLP Safety/Toxicology studies.
The results of the bio-analytical assays on blood samples collected from the minipigs and rats will be used for toxicokinetic analyses as part of the safety profile of NV-HHV-101. The Company is planning that the bio-analytical assays and pharmacokinetic analyses required for the human clinical trials also to be performed by NorthEast BioLab.
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.
About NorthEast BioLab
NorthEast BioAnalytical Laboratories LLC (NorthEast BioLab) has in-depth expertise in analytical testing laboratory services to perform in-vitro and in-vivo testing of chemicals and assessing their efficacy for intended therapeutic value. The company has 15+ years of experience as an analytical services laboratory committed to developing and validating robust bioanalytical methods per FDA guidance and has developed outstanding processes and standard operating procedures (SOPs) for streamlining drug testing and analysis with the primary objective of expedited FDA drug approval.
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, shingles and chickenpox, 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 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. EMA refers to the European Union's office of European Medicines Agency.)
SOURCE: NanoViricides, Inc.