NanoViricides Has Initiated IND-Enabling Safety/Toxicology Studies for Its First Drug Candidate Moving towards Human Clinical Trials
SHELTON, Conn., Feb. 4, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a company with novel platform technology to treat difficult and life-threatening viral diseases, announces that its first drug candidate has now entered IND-enabling Safety/Toxicology studies moving towards human clinical trials.
The first part of the IND-enabling Safety/Toxicology studies for the shingles drug candidate began towards the end of December, 2018. These studies are being conducted by BASi, Indiana, a Contract Research Organization specialized in IND-enabling safety/toxicology studies.
The first of these studies, namely non-GLP Safety/Tolerability and Toxicity using Dermal Exposure in Mini-Pigs, began at the very end of December, 2018. Following initial observations on this mini-pigs study, the next non-GLP studies for Systemic Exposure using sub-cutaneous administration in Rats has begun in the second week of January, 2019. Another study of Systemic Exposure using sub-cutaneous administration in Dogs has also begun recently.
The Company expects to report on these various studies as soon as the data become available to us and is reviewed by our scientists. The Company is negotiating the earliest possible date for entering the next phase, namely, the GLP Safety/Toxicology studies with BASi at present.
The Company has employed its drug candidate, namely, NV-HHV-101, for these non-clinical IND-enabling studies. Two related development candidates in the HerpeCide™ program were previously tested by the Company in non-GLP Safety and Tolerability study in rats for dermal exposure as well as systemic exposure by subcutaneous and intravenous routes of administration. The Company previously reported in April, 2018, that those candidates were both found to be safe based on multiple parameters in the then completed non-GLP Tolerability study. No clinically observable adverse safety and toxicology effects were seen in that study of the Company's optimized topical dermal drug candidates.
On the basis of these previous studies, the Company engaged in scale-up for large scale production of the development candidates while simultaneously also further optimizing the candidates for quality control and for effectiveness.
The effectiveness of the drug candidates against VZV, the virus that causes chickenpox in children and shingles in adults, continues to be evaluated by Professor Moffat in the human skin organ culture model at the Upstate Medical Center, SUNY Syracuse, NY.
The Company has chosen the candidate now called NV-HHV-101 as the clinical drug candidate based on these drug candidate optimization studies.
Assuming that the safety/toxicology studies are successful, the Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication.
The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, to develop for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The Company has a license to the TheraCour® technologies for HSV-1 and HSV-2 and the license for VZV Shingles is currently in progress.
The cell culture based evaluation of drug candidates for HSV-1, HSV-2 and VZV is performed in our own BSL2 Virology lab. The animal studies for HSV-1 and HSV-2 indications will be performed by Professor Brandt at the CORL facility at the University of Wisconsin, Madison, WI. The Brandt team is currently working on optimizing their animal models so that drugs that may be superior to existing treatments can be discriminated from the existing treatments.
In another news, the Company confirms that its CEO, Dr. Irach Taraporewala has resigned effective January 31, 2019, for personal reasons, and will continue as a Consultant to help the Company with its regulatory advance as needed. The Company has signed a consulting agreement with him for two years, ending in January 2021. The Company has filed a current report Form 8-K with the SEC for this event. The Board has elevated Dr. Anil Diwan, the Company's President and Chairman of the Board, to Executive Chairman in order to undertake the additional executive responsibilities at present. The Company has continued to undertake austerity measures, and activate available options to reduce its expenditures while taking care that the timeline for moving its first drug candidate into human clinical trials is not adversely affected.
NanoViricides, Inc. is a global leader in the application of nanomedicine technologies to the complex issues of developing effective treatments for viral diseases. The nanoviricide® platform technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody.
Our anti-viral therapeutics, that we refer to as "nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus-binding portion of the nanoviricide is engineered appropriately. In addition, any mutated viruses that develop in vivo under a nanoviricide drug treatment regimen would be expected to be inefficient in infecting human cells, and thus incompetent.
With the nanoviricide platform technology, the Company has previously demonstrated that highly effective anti-viral drug candidates can be created against complex diseases such as Influenza, HIV/AIDS, Dengue, and Ebola/Marburg, to name a few.
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 Company anticipates achieving several additional important milestones in the current calendar year towards firmly establishing its nanoviricide platform technology. With this press release we announce that we have successfully met the milestones of declaring our first clinical drug candidate and of initiating IND-enabling Safety/Tox Package studies for the same. The additional milestones that the Company anticipates achieving in the current calendar year 2019 include establishing successful cGMP-like production of the drug as required for the "Tox Package" studies, further enhancing the production capability to make human clinical product batches, successful completion of the Tox Package studies, a "Pre-IND" meeting with the FDA, filing of an IND, and the beginning of initial human clinical trials. The timelines for meeting these milestones depend upon several external factors not under the control of the Company, including availability of project time windows at the various service providers for Efficacy studies, Safety/Tox Package studies, Clinical Trials, and the availability of adequate capital.
The Company's most advanced pre-clinical drug candidate is our anti-VZV nanoviricide for the topical treatment of shingles, being developed as a skin cream. In cell culture studies, a tested development candidate was as much as five times more effective than acyclovir, the current standard of care. These anti-VZV drug candidates have also shown strong effectiveness in studies involving VZV infection of human skin patches ex vivo. These studies were conducted by Professor Jennifer Moffat at the SUNY Upstate Medical Center in Syracuse, NY, an internationally recognized expert on varicella-zoster virus (VZV) infection, pathogenesis, and anti-viral agent discovery. Some of the work was presented at the 31st International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal.
Our drug programs address a market size in the range of $40 Billion to $70 Billion by various estimates. We are thus poised for strong growth with a number of drug candidates in a multitude of disease indications in our broad and deep pipeline enabled by our platform technology.
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.)
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