1. How to use GuruFocus - Tutorials
  2. What Is in the GuruFocus Premium Membership?
  3. A DIY Guide on How to Invest Using Guru Strategies
PRNewswire
PRNewswire
Articles 

NanoViricides Announces Completion of Production of its Lead Candidate for Upcoming GLP Tox Package Studies

May 13, 2019 | About:

PR Newswire

SHELTON, Conn., May 13, 2019 /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.

Targeted Virus-Killing Nanomedicines (PRNewsFoto/NanoViricides, Inc.)

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.

About NanoViricides
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.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nanoviricides-announces-completion-of-production-of-its-lead-candidate-for-upcoming-glp-tox-package-studies-300848606.html

SOURCE NanoViricides, Inc.


Rating: 5.0/5 (1 vote)

Voters:

Comments

robertjessica52
Robertjessica52 - 1 week ago    Report SPAM

Natural Herbs have cured so many sickness and diseases that drugs and injection cant cure. I've seen the great importance of natural herbs and the wonderful work they have done in people's lives. i read people's testimonies online on how they were cured of Herpes, Hiv, Diabetics etc by Dr. Ameola herbal medicine, so i decided to contact the doctor because i know nature has the power to heal anything. I was diagnosed with Herpes for the past 8 years but Dr. Ameola cured me with his herbs and i referred my aunt and her husband to him immediately because they were both suffering from Hiv and they were cured too. I know is hard to believe, but am a living testimony. There is no harm trying herbs. He is also a spell caster, he cast spells to restore broken marriages and a good luck spells to prosper and excel in life. You can Contact him on ( [email protected] ) or WhatsApp him via +14158551136

Rajushunde
Rajushunde - 1 week ago    Report SPAM

I want to appreciate Dr. APAMA for his wonderful work and help to mankind because I never believed I could ever be healed of Hepatitis B Virus after many years of suffering from this Disease. I have been reading testimonies of people who got healed of their diseases but I never knew I would one day be a beneficiary of Dr. APAMA Herbs because no one to believe again and there is nothing like trust again after I was scammed many time by those who claimed they can cure me and made away with the little I have but here I am today sharing my testimonies after using Dr. APAMA herbal medicines, My story has totally changed I can now do everything I could not do and all the symptoms are totally gone no more abdominal pains, Dark Urine, joint pains and weaknesses and I can eat all the time no more lost of Appetite. If you are sick, It's my advise you write Dr. APAMA on [email protected] OR Whatsapp/+2349072570496 and he will definitely help you too because he is kind and wonderful. If you have HIV, HEPATITIS, HPV, CANCER, DIABETES And many more Dr. APAMA will help you . My Email is [email protected]

Rajushunde
Rajushunde - 1 week ago    Report SPAM

I want to appreciate Dr. APAMA for his wonderful work and help to mankind because I never believed I could ever be healed of Hepatitis B Virus after many years of suffering from this Disease. I have been reading testimonies of people who got healed of their diseases but I never knew I would one day be a beneficiary of Dr. APAMA Herbs because no one to believe again and there is nothing like trust again after I was scammed many time by those who claimed they can cure me and made away with the little I have but here I am today sharing my testimonies after using Dr. APAMA herbal medicines, My story has totally changed I can now do everything I could not do and all the symptoms are totally gone no more abdominal pains, Dark Urine, joint pains and weaknesses and I can eat all the time no more lost of Appetite. If you are sick, It's my advise you write Dr. APAMA on [email protected] OR Whatsapp/ 2349072570496 and he will definitely help you too because he is kind and wonderful. If you have HIV, HEPATITIS, HPV, CANCER, DIABETES And many more Dr. APAMA will help you . My Email is [email protected]

Wencheklopp2
Wencheklopp2 - 1 week ago    Report SPAM

Greetings to the general public, I'm Wenche Klopp from Stavanger Norway. I have been living with Hiv virus for 7years and I was cheated three times and many false Doctors took advantage of this Disease to deceive me and took my hard earned money, As a result of my experience I do not have to blame some people finding it difficult to believe there is a cure for hiv Virus. I have been HIV-positive for years but today, I'm happy to be HIV-negative using Dr. APAMA 's herbal remedies. I have been going to places and doing research looking for help on the Internet when I came across people sharing testimonies about how Dr. APAMA cured them of HIV, HERPES, CANCERS, HEPITIS, HPV, TUMOR And many other diseases medically incurable. I always thought there is no solution because I have tried so many things but didn't work. I talked to Dr. APAMA as I explained my health status to him. Fortunately for me, I received the medicine and used it according to the instructions after meeting the requirements. I'm very glad and I want to share my experience to everyone for the benefit of those going through one Disease and the other to please quickly contact this great Man by whatsapp: +2349072570496 OR at Email: [email protected]. I have also referred to Dr. APAMA those looking for the following cure: Hpv, herpes, Vaginal infections, hepatitis B, Cancers, hepatitis C, infertility problem, diabetes, Kidney problem, asthma and more. My Email is [email protected]

merritchelsea9
Merritchelsea9 - 3 days ago    Report SPAM

Hello everyone, I'm excited to share this Wonderful Experience with everybody out there suffering from herpes virus, It all started with my husband having some strange symptoms in the past unknowingly this was herpes and as husband and wife we were all together as usually until I started having symptoms and weaknesses too. This kept degenerating even as we were given and undergoing various treatments. We have tried some herbal medicines here in the states but didn't work I was confused and frustrated at a point until I saw a testimony of a lady Sabrina who was healed of HIV after using Dr. APAMA herbal medicines. At first I never believed because this doesn't have any medical base or explanation that one can be healed of these viruses, After some time I had to write the lady for inquiring and she insisted I should write Dr. APAMA for help which I did and I never believed this could work for us as we got the herbs and the most surprising thing just within 8days I was getting stronger no itching and the painful sores were all clearing off and the Blisters were clearing and both myself and my man noticed significant changes compared to the symptoms we were having and we patiently waited to complete the treatment as instructed by this wonderful Doctor APAMA. And after the third week we were both confirmed herpes Negative. I remained ever grateful and please join us to Appreciate Dr APAMA for his kind gestures and this remarkable experiences. If you're sick of HERPES, HIV, HPV, CANCERS, HEPATITIS, DIABETES And any sickness or Diseases contact Dr. APAMA On [email protected] and His whatsapp is +2349072570496. I wish you same healing, this is my Email: [email protected]

Please leave your comment:


Performances of the stocks mentioned by PRNewswire


User Generated Screeners


pjmason14Momentum
pascal.van.garsseHigh FCF-M2
kosalmmuse6
kosalmmuseBest one1
DBrizanall 2019Feb26
kosalmmuseBest one
DBrizanall 2019Feb25
kosalmmuseNice
kosalmmusehan
MsDale*52-Week Low
Get WordPress Plugins for easy affiliate links on Stock Tickers and Guru Names | Earn affiliate commissions by embedding GuruFocus Charts
GuruFocus Affiliate Program: Earn up to $400 per referral. ( Learn More)

GF Chat

{{numOfNotice}}
FEEDBACK