Shelton, CT /PRNewswire/ - NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to meet unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has successfully completed manufacture of the drug for the upcoming GLP Safety/Toxicology study of its lead candidate in several kilogram quantities.
The Company has successfully completed production of kilogram-scale quantities of the drug substance, NV-HHV-101. Additionally, the Company has also successfully completed its formulation into the skin cream drug product at several kilograms scale, as is anticipated for the upcoming GLP Safety/Toxicology study.
The Company has achieved an extremely important milestone with this accomplishment. The manufacture of the drug substance and its formulation into drug product were both accomplished under cGMP conditions, at our own facility in Shelton, CT.
The Company believes it has de-risked the cGMP manufacture of not just NV-HHV-101, but that it has also substantially de-risked the entire nanoviricide® platform regarding cGMP manufacturing capability. It is well known that cGMP manufacture of nanomedicines is a challenging aspect in nanomedicines drug development.
The Company further provides an update that it is awaiting comments from the US FDA on its pre-IND application for NV-HHV-101. Those comments, when received, will inform further studies towards IND filing. Once the GLP Tox Package studies are complete, and associated analyses are complete, the Company expects to receive reports from relevant external parties. These reports and a plan of the clinical studies will then be developed into an IND application for NV-HHV-101.
Thus, the Company is successfully executing rapidly on all fronts towards the goal of filing an IND as soon as possible.
The Company is developing NV-HHV-101 as a broad-spectrum drug against a number of herpes viruses. The Company has chosen shingles rash as the first indication for this drug candidate. It is being developed as a dermal topical cream. It is designed to reduce the local viral load, thereby minimizing rash progression and further nerve damage.
There is a significant unmet medical need for the topical treatment of shingles rash. An effective therapy has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy against shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine.
NanoViricides has previously shown that the NV-HHV-101 drug candidate as well as several related candidates in the pre-clinical optimization phase were highly effective against the shingles virus, VZV (Varicella-Zoster-Virus), in a human skin organ culture ex vivo model of the disease. Further, the non-GLP Safety/Toxicology studies of NV-HHV-101 have shown an excellent safety profile, with no adverse events even at the highest dosages tested in the safety/tox studies.
The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications at present.
The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into several 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.
Existing drugs given systemically may not reach required concentrations at the site of shingles outbreak, limiting effectiveness. In addition, VZV does not have an effective TK enzyme that is required for producing active drug from the acyclovir class of pro-drugs, requiring frequent administration of large doses. While shingles presents with a debilitating "pins-and-needles" pain associated with the characteristic rash that is self-limiting within 2-3 weeks in most patients, in a substantial percentage of patients, it presents as a severe, debilitating disease that leads to complications including hospitalization(s) and in some cases may result in extended treatments including subsequent surgeries, as highlighted in NBC-News recently in the article Chickenpox is a lifelong herpes virus that comes with a serious side effect.
Limiting initial viral load is expected to minimize the occurrence of such complications, and is also expected to reduce the incidence of post-herpetic-neuralgia ("PHN"), which is defined as persistent pain six months or longer after the initial rash has subsided. Shingles occurs when the immune system weakens due to age, stress or other factors such as other immune-compromising diseases (such as HIV or other viral infections) or conditions (such as organ transplant or anti-immune therapeutics against auto-immune diseases). The epidemiological incidence rate of shingles suggests that almost every person will have shingles at least once in lifetime if he/she reaches an age of 85. The available Zostavax® and other live attenuated virus vaccines often lead to "rebound shingles", a less severe form of the disease. The new Shingrix® GSK vaccine does not contain live virus, but is reported to have debilitating side reactions in as many as 20-25% of persons that receive it. Such side reactions may be expected to limit the vaccination rate since shingles is not a life-threatening disease. Besides, Shingrix is not yet widely available, due to limited production capacity. Thus there continues to be a significant unmet medical need for new, effective, therapeutics against shingles.
The present indication for NV-HHV-101 is for the treatment of shingles rash caused by reactivation of the shingles virus, VZV (varicella-Zoster-Virus). VZV causes chickenpox in children as a result of primary infection, and then becomes latent. Reactivation occurs in adulthood when immune surveillance weakens, due to age, stress, or other immune-compromising factors, including other diseases.
NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM ("herpesvirus entry mediator") receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.
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 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 drug application. API refers to active pharmaceutical ingredient.
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