NanoViricides Nominates a Novel Candidate for Advancing Into Clinical Trials for Treatment of COVID-19
- 2020年09月16日 21:05:00
- テクノロジー
- JCN Newswire
The Company has accelerated its drug development program for COVID-19 with the goal of creating the most effective medicine to obtain regulatory approval for emergency use in the COVID-19 pandemic in the shortest timeline feasible, after achieving proof of concept of broad-spectrum anti-coronavirus effectiveness of test candidates.
The Company therefore aggressively worked to harness the full power of the nanoviricides®nanomedicine platform to achieve these objectives.
A curative treatment for a virus such as SARS-CoV-2 coronavirus would require a multi-faceted attack that shuts down (i) ability of the virus to infect host cells and simultaneously, (ii) ability of the virus to multiply inside the host cells. The nanoviricide®platform enables direct multi-point attack on the virus that is designed to disable the virus and its ability to infect new cells. At the same time, a nanoviricide is also capable of carrying payload in its "belly"(inside the micelle) that can be chosen to affect the ability of the virus to replicate. The nanoviricide is designed to protect the payload from metabolism in circulation. Thus, the nanoviricide platform provides an important opportunity to develop a curative treatment against SARS-CoV-2, the cause of COVID-19 spectrum of pathologies.
The clinical candidate the Company has chosen is identified as NV-CoV-1-R. It is made up of a nanoviricide that we have found to possess broad-spectrum anti-coronavirus activity, now identified as NV-CoV-1, and remdesivir encapsulated inside the core of NV-CoV-1. NV-CoV-1 itself is designed to attack the virus particles themselves, and possibly would also attack infected cells that display the virus antigen S-protein, while sparing normal (uninfected) cells that do not display the S-protein. Additionally, remdesivir is widely understood to attack the replication cycle of the virus inside cells. Thus the combined attack enabled by NV-CoV-1-R on the virus could prove to be a cure for the infection and the disease, provided that the necessary dosage level can be attained without undue adverse effects. Human clinical trials will be required to determine the safety and effectiveness of NV-CoV-1-R.
Remdesivir is a well-known antiviral drug (developed by Gilead) that has been approved for emergency use treatment of SARS-CoV-2 infection or COVID-19 in several countries. NV-CoV-1 is a novel agent that is being used as an adjuvant to remdesivir in creating NV-CoV-1-R, to improve the overall effectiveness. It is well known that remdesivir suffers from rapid metabolism in circulation that breaks down the prodrug to its nucleoside form which is not readily phosphorylated. The Company anticipates that encapsulation in NV-CoV-1 may protect remdesivir from this rapid metabolism. If this happens, the effective level and stability of remdesivir in the body would increase. This increase may lead to increased effectiveness if there are no adverse effects. Such increased effectiveness, if found, may also allow reduction in the required dosage of remdesivir in the encapsulated form, i.e. as NV-CoV-1-R. In this sense, NV-CoV-1 can be viewed to act as an adjuvant that enhances the effect of remdesivir, a known antiviral against SARS-CoV-2.
"This is an extremely important milestone for the Company,"said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "We look forward to rapid development of the IND enabling core safety pharmacology studies and, thereafter, human clinical development on an accelerated timeline in these trying times of the pandemic."
About NanoViricides
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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we have declared a clinical development candidate, namely NV-CoV-1-R, which encapsulates remdesivir inside NV-CoV-1, for the treatment of COVID-19. The Company cannot project an exact date for filing an IND for NV-CoV-1-R because of its dependence on a number of external collaborators and consultants.
The Company is now working on performing required safety pharmacology studies and completing an IND application for NV-CoV-1-R. The Company believes that since remdesivir already has an emergency use approval, NV-CoV-1-R is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed NV-CoV-1-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
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. 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 and Ebola/Marburg viruses. The Company has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. 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. for specific application verticals of specific viruses, as established at its foundation in 2005.
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 application refers to "Investigational New Drug"application. CMC refers to "Chemistry, Manufacture, and Controls".
CONTACT:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
Copyright 2020 JCN Newswire. All rights reserved. www.jcnnewswire.com
少女にみだらな行為で逮捕…38歳俳優が謝罪も「僕はまだ、表現者として生きたい」活動継続へ
ヤリスは「X」で十分か、徹底検証!おすすめグレードも解説
山田涼介は「言えば何でもくれます」…姉さん女優の猛攻に「やめろよ」とタジタジ
宮迫博之の長男、“父の因縁”チバテレ出演で謝罪「いくつやれば気が済むのか…」
「パーマン1号」「カリメロ」声優の三輪勝恵さん死去、80歳 急性肺塞栓「青二」プロ発表
河村たかし氏「ウソを言ったことはない」 「最後の市長選」発言も?
玉川徹氏、大谷翔平は「二刀流は魅力だけど3冠王はすごい」長嶋一茂「今年は安心して見られる」
サイキックフィーバーが「大阪・関西万博 EXPO2025デジタルウォレット」発表会出席
「パーマン・カリメロ」「峰不二子」「金田一少年」国民的作品を彩った声優の訃報相次ぐ
元G大阪スタッフが始めた「アスリート×ファッション」のインスタ投稿 選手の価値向上を目指す
何があった!?「エアコン」が想定外の壊れ具合!投稿者に話を聞いた
「あまりにもデカすぎる…」三田悠貴、迫力バスト際立つ小面積ビキニショットにネット騒然
【ネタバレ?】史実で見るキングダムの今後の展開まとめ〜中華統一までの全体像
丸亀製麺の「丸亀うどーなつ」が販売開始で完売店舗続出!過去の「うどんで作ったドーナッツ」と比較すると……
ひまそらあかねを無視するマスコミ、岩下の新生姜社長が名前を出すだけで「不買運動」が叫ばれる事態に
玉置浩二の妻、青田典子(53)の現在がとんでもない事になっていると話題に
「エロい」42歳山川恵里佳、白ビキニのオフショ動画4連発!20年ぶりグラビア復帰「最ッ高」
中国・日本人母子刺傷 止めに入ったバス案内係の中国人女性死亡
岡本夏生(56)、1600日ぶりにブログを更新した現在が衝撃
株主優待の桐谷さん「アダルトサイトを見てたらウィルス感染」正直投稿 修復のお礼はやはり…
何があった!?「エアコン」が想定外の壊れ具合!投稿者に話を聞いた
玉置浩二の妻、青田典子(53)の現在がとんでもない事になっていると話題に
【ネタバレ?】史実で見るキングダムの今後の展開まとめ〜中華統一までの全体像
ガーシーが綾野剛のLINE公開でネット騒然「ショック」「すごいエンタメ」
イケメンだから許される!堀北真希と山本耕史の「馴れ初め」が映画化希望するレベル
ユーチューバーもこう氏、元彼女・成海瑠奈について赤裸々告白
「愛が生まれた日」藤谷美和子(56)の現在がヤバい!?徘徊生活を送っていた過去も明らかに。
柏原崇(45)現在を調べてみた結果、相変わらずかっこよすぎた!
都知事選掲示板にヌードポスター ひろゆき氏「世も末」 SNSで批判噴出
岡本夏生(56)、1600日ぶりにブログを更新した現在が衝撃
![game_banner](/images/banner-game.png)
少女にみだらな行為で逮捕…38歳俳優が謝罪も「僕はまだ、表現者として生きたい」活動継続へ
ヤリスは「X」で十分か、徹底検証!おすすめグレードも解説
山田涼介は「言えば何でもくれます」…姉さん女優の猛攻に「やめろよ」とタジタジ
「パーマン1号」「カリメロ」声優の三輪勝恵さん死去、80歳 急性肺塞栓「青二」プロ発表
宮迫博之の長男、“父の因縁”チバテレ出演で謝罪「いくつやれば気が済むのか…」
河村たかし氏「ウソを言ったことはない」 「最後の市長選」発言も?
サイキックフィーバーが「大阪・関西万博 EXPO2025デジタルウォレット」発表会出席
玉川徹氏、大谷翔平は「二刀流は魅力だけど3冠王はすごい」長嶋一茂「今年は安心して見られる」
「パーマン・カリメロ」「峰不二子」「金田一少年」国民的作品を彩った声優の訃報相次ぐ
元G大阪スタッフが始めた「アスリート×ファッション」のインスタ投稿 選手の価値向上を目指す