SHELTON, CT / ACCESSWIRE / July 1, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the 'Company'), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, elaborates on its current assets and plans towards becoming a successful pharmaceutical company intending to revolutionize the treatment of viral infections..

SHELTON，CT/ACCESSWIRE/July 1，2024/NanoViricides，Inc.（纽约证券交易所美国证券交易所：NNVC）（“公司”）是广谱抗病毒纳米药物临床阶段的全球领导者，详细介绍了其现有资产，并计划成为一家成功的制药公司，旨在彻底改变病毒感染的治疗方法。。

NV-387, our lead broad-spectrum antiviral drug candidate has completed Phase I clinical trial in healthy subjects with no drop-outs and no reported adverse events, indicative of excellent safety and tolerability in humans.

NV-387是我们的主要广谱抗病毒候选药物，已在健康受试者中完成了I期临床试验，没有辍学，也没有报告不良事件，表明人体具有良好的安全性和耐受性。

This single drug, NV-387, has been found to be highly active against a number of different types of viruses. In fact, its activity has, in animal models:

。事实上，在动物模型中，它的活动有：

Resulted in curing lethal lung RSV infection;

导致治愈致命的肺部RSV感染；

Substantially bested the activities of approved drugs (Tamiflu, Xofluza, Rapivab) for Influenza;

大大超过了批准的流感药物（达菲，Xofluza，Rapivab）的活性；

Substantially bested the activity of Remdesivir against lethal coronavirus infection; and

基本上超过了雷姆德西韦对致命冠状病毒感染的活性；和

Matched the activity of TPOXX against poxvirus.

与TPOXX对痘病毒的活性相匹配。

We believe that this ultra-broad-spectrum antiviral activity of NV-387 became possible because NV-387 is designed to mimic an invariant host feature that over 90% human pathogenic viruses employ for attachment and infection.

我们认为NV-387的这种超广谱抗病毒活性成为可能，因为NV-387被设计为模仿超过90%的人类致病病毒用于附着和感染的不变宿主特征。

A single antiviral drug that can effectively treat almost any respiratory viral infection would be a revolutionary development in the treatment of viral diseases, reminiscent of the revolution caused by penicillin in the treatment of bacterial infections, we believe.

我们相信，一种可以有效治疗几乎任何呼吸道病毒感染的单一抗病毒药物将是病毒性疾病治疗的革命性发展，让人想起青霉素在治疗细菌感染方面引起的革命。

We are rapidly moving towards Phase II studies to establish effectiveness against a viral disease in humans. We plan on Phase II studies for RSV, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV infection.

我们正在迅速进行II期研究，以确定对人类病毒性疾病的有效性。我们计划对RSV进行II期研究，目的是开发一种治疗儿科患者的治疗方法，这是RSV感染中最大的未满足需求。

The market sizes for the viral diseases that NV-387 has already been found to be a viable clinical drug candidate as above are substantial.

如上所述，已经发现NV-387是可行的临床候选药物的病毒性疾病的市场规模很大。

The market size for RSV is estimated at $2.6 Billion in 2024, growing to $4.3 Billion in three years, at a rate of 18.9% as reported by GrowthPlusReports1.

据GrowthPlusReports1报道，2024年RSV的市场规模估计为26亿美元，三年内增长至43亿美元，增长率为18.9%。

The market size for Influenza and Bird Flu is estimated at $4.6 Billion in 2024, growing to an estimated $5.9 Billion in three years, at a rate of 8.5% as reported by DelveInSight2. In case a pandemic occurs, reality may outrun such projections by magnitudes, as was seen with the COVID pandemic.

据DelveInSight2报道，2024年流感和禽流感的市场规模估计为46亿美元，三年内增长至59亿美元，增长率为8.5%。如果发生大流行，现实可能会在很大程度上超过这些预测，正如新型冠状病毒大流行所见。

The market size for COVID, as it has become an endemic disease by now, can be expected to be similar to the market size for Influenza while new COVID drugs are being developed, since COVID continues to cause at least twice as large a fatality rate as Influenza in the USA alone.

由于新型冠状病毒目前已成为一种地方性疾病，因此在开发新型冠状病毒药物的同时，预计其市场规模将与流感的市场规模相似，因为新型冠状病毒继续导致的死亡率至少是美国流感的两倍。

Thus we estimate an overall market size of around $16 Billion in three years for these three viruses, that NV-387 is expected to tackle.

因此，我们估计NV-387预计将在三年内解决这三种病毒的总体市场规模约为160亿美元。

Thus NV-387 alone is poised to propel NanoViricides towards great success in a near-term horizon. We plan to license or co-develop our various drug candidates against multiple viral diseases to other Pharma Companies. In addition, we plan on seeking non-dilutive funding for the development of drugs that are of interest for biodefense..

。我们计划向其他制药公司许可或共同开发针对多种病毒性疾病的各种候选药物。此外，我们计划寻求非稀释性资金，用于开发对生物防御感兴趣的药物。。

We have already demonstrated the ability to manufacture our own drug candidates at several Kilograms scales in cGMP-compliant processes for clinical trials. Our campus comprises a multi-Kg scale cGMP-compliant manufacturing facility with Class 100 clean rooms. We have demonstrated capabilities for manufacture of the drug substance, and thereafter formulate, fill-finish-and-package the drug products for clinical trials in this facility..

我们已经证明能够在符合cGMP的临床试验过程中以几公斤的规模生产我们自己的候选药物。我们的校园包括一个多公斤规模的cGMP兼容生产设施，拥有100级洁净室。我们已经证明了生产药物的能力，然后在该设施中配制，填充，完成和包装药物产品用于临床试验。。

We believe that our existing manufacturing facility would be adequate for market entry of NV-387 for the pediatric patients segment when the drug is approved by the FDA.

。

We also have a drug in development against herpesviruses, NV-HHV-1, formulated as a skin cream, that we plan on advancing through clinical trials for regulatory approval as a topical treatment of Shingles/Chickenpox skin rashes, HSV-1 'cold sores', as well as HSV-2 'genital ulcers'. NV-HHV-1 had completed IND-enabling studies by October 2019 just before the COVID-19 pandemic broke out, whereupon we took up the challenge of developing a highly effective drug to treat all coronavirus infections.

我们还正在开发一种抗疱疹病毒的药物NV-HHV-1，它是一种皮肤霜，我们计划通过临床试验进行监管批准，作为局部治疗带状疱疹/水痘皮疹，HSV-1“冻疮”以及HSV-2“生殖器溃疡”。NV-HHV-1在COVID-19大流行爆发之前，于2019年10月完成了IND启用研究，因此我们接受了开发一种高效药物治疗所有冠状病毒感染的挑战。

We have an oral formulation of NV-HHV-1 in development for systemic use to treat herpesvirus infections..

我们正在开发NV-HHV-1口服制剂，用于全身治疗疱疹病毒感染。。

Our unique, host-mimetic, directly virus-attacking, technology platform has enabled the development of a number of drug candidates against several viral diseases. We believe these developments will continue to provide additional drug candidates to feed our pipeline for several years to come.

我们独特的，模拟宿主的，直接攻击病毒的技术平台已经能够开发出许多针对几种病毒性疾病的候选药物。我们相信，这些发展将继续提供更多的候选药物，以满足我们未来几年的需求。

Thus, we believe that we are on the verge of substantial success and expansive growth in the near future:

因此，我们相信，在不久的将来，我们即将取得实质性的成功和巨大的增长：

having successfully completed Phase I of our first drug candidate,

成功完成了我们第一个候选药物的第一阶段，

having amassed substantial data demonstrating superior antiviral activity of our drug candidates in animal models,

，

and now being poised to enter into Phase II human clinical trials.

现在正准备进入II期人体临床试验。

About NanoViricides

关于纳米杀病毒剂

NanoViricides, Inc. (the 'Company') (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.

NanoViricides，Inc.（以下简称“公司”）（www.NanoViricides.com）是一家处于发展阶段的公司，正在开发用于抗病毒治疗的特殊用途纳米材料。该公司的新型纳米杀病毒剂®候选药物旨在专门攻击包膜病毒颗粒并将其拆除。

Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs..

此外，纳米杀病毒剂模仿了病毒尽管发生突变仍需要的宿主侧特征，因此病毒极不可能逃脱杀病毒剂药物。。

Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages.

我们的主要候选药物是NV-387（药品NV-CoV-2），用于治疗RSV，COVID-19，长COVID，流感，禽流感H5N1和其他呼吸道病毒感染。NV-387在健康受试者中成功完成了1a/1b期人体临床试验，即使在最高剂量和重复剂量下也没有报告不良事件。

This trial was conducted by the drug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India..

该试验由药物赞助商Karveer Meditech Pvt.Ltd.进行，Karveer Meditech Pvt.Ltd.是我们在印度的持牌人和合作者。。

The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.

该公司目前专注于将NV-387推进治疗RSV感染的II期人体临床试验。

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 'cold sores' and HSV-2 'genital ulcers'. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants.

我们的另一个高级候选人是NV-HHV-1，用于治疗带状疱疹，HSV-1“冷疮”和HSV-2“生殖器溃疡”。由于依赖于许多外部合作者和顾问，该公司无法预测其任何药物的IND申报的确切日期。

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel.

该公司还正在开发针对多种病毒性疾病的药物，包括口腔和生殖器疱疹、眼部病毒性疾病，包括EKC和疱疹性角膜炎、H1N1猪流感、H5N1禽流感、季节性流感、艾滋病毒、丙型肝炎、狂犬病、登革热和埃博拉病毒等。纳米杀病毒剂的平台技术和程序基于TheraCour的TheraCour®纳米医学技术，TheraCour从AllExcel获得许可。

NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses.

纳米杀病毒剂拥有该技术的全球独家永久许可证，可用于治疗以下人类病毒性疾病的几种具有特定靶向机制的药物：人类免疫缺陷病毒（HIV/AIDS），乙型肝炎病毒（HBV），丙型肝炎病毒（HCV），狂犬病，单纯疱疹病毒（HSV-1和HSV-2），水痘带状疱疹病毒（VZV），流感和亚洲禽流感病毒，登革热病毒，日本脑炎病毒，西尼罗河病毒，埃博拉/马尔堡病毒和某些冠状病毒。

The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc.

如果初步研究成功，该公司打算获得痘病毒和/或肠道病毒的许可证。该公司的技术基于TheraCour Pharma，Inc.在这些领域开发的药物的广泛，独家，可再许可的现场许可。该公司的商业模式基于TheraCour Pharma Inc.的许可技术。

for specific application verticals of specific viruses, as established at its foundation in 2005..

针对特定病毒的特定应用垂直领域，于2005年成立。。

As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development.

按照惯例，公司必须说明风险因素，即任何药品的典型药物开发路径都非常漫长，需要大量资金。与任何公司的任何药物开发工作一样，目前还不能保证该公司的任何候选药物都能显示出足够的有效性和安全性，用于人类临床开发。

Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product..

此外，目前还不能保证我们实验室对冠状病毒的成功结果将导致成功的临床试验或成功的药物产品。。

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.

。实际事件可能与本文预测的事件存在重大差异，并取决于许多因素。本版本中的某些声明，以及纳米杀病毒剂公司的其他书面或口头声明。

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.

。您不应过度依赖前瞻性陈述，因为它们涉及已知和未知的风险、不确定性和其他因素，在某些情况下，这些因素超出了公司的控制范围，并且可能会对实际结果、活动水平、绩效或成就产生重大影响。

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.

公司没有义务以任何理由公开更新或修订这些前瞻性声明，也没有义务更新实际结果可能与这些前瞻性声明中预期的结果有重大差异的原因，即使将来有新的信息可用。可能导致实际结果与公司预期存在重大差异的重要因素包括但不限于在“风险因素”标题下以及公司不时向美国证券交易委员会和其他监管机构提交的文件中披露的因素。

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 t.

虽然不可能预测或确定所有这些因素，但它们可能包括以下内容：在临床前试验中证明纳米杀病毒剂是安全有效的；成功开发我们的候选产品；我们寻求和获得监管部门批准的能力，包括t。

The phrases 'safety', 'effectiveness' and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

本新闻稿中使用的短语“安全性”，“有效性”和等效短语是指包括临床试验在内的研究结果作为常规研究用法，并不表示美国FDA对安全性或有效性的评估。

'NOAEL' means 'No-Observed-Adevrese-Event-Level', which is the maximum dosage employed at which there were no adverse events found in animal studies.

“NOAEL”是指“未观察到Adevrese事件水平”，这是在动物研究中未发现不良事件的最大剂量。

'MTD' means 'Maximum Tolerated Dose', which is the maximum dosage employed that does not compromise survival of the animals.

“MTD”是指“最大耐受剂量”，即不影响动物存活的最大剂量。

FDA refers to US Food and Drug Administration. IND application refers to 'Investigational New Drug' application. cGMP refers to current Good Manufacturing Practices. CMC refers to 'Chemistry, Manufacture, and Controls'. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines.

FDA指的是美国食品和药物管理局。IND申请是指“研究性新药”申请。cGMP是指当前良好的生产实践。。CHMP是指人类使用药品委员会，它是欧洲药品管理局（EMA）负责人类药物的委员会。

API stands for 'Active Pharmaceutical Ingredient'. API means active pharmaceutical ingredient..

API代表“活性药物成分”。API是指活性药物成分。。

References:

参考文献：

https://www.growthplusreports.com/report/respiratory-syncytial-virus-rsv-therapeutics-market/8519

https://www.growthplusreports.com/report/respiratory-syncytial-virus-rsv-therapeutics-market/8519

https://www.delveinsight.com/report-store/influenza-a-infections-market?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr

https://www.delveinsight.com/report-store/influenza-a-infections-market?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr

Contact:

NanoViricides, Inc.

纳米杀病毒剂，股份有限公司。

info@nanoviricides.com

info@nanoviricides.com

Public Relations Contact:

公共关系联系人：

MJ Clyburn, TraDigital IR

MJ Clyburn，TraDigital IR

clyburn@tradigitalir.com

clyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.

资料来源：纳米杀病毒剂公司。

View the original press release on accesswire.com

在accesswire.com上查看原始新闻稿