NanoViricides Inc. (NNVC)

[changes_iv]

I did not say tox studies would complete 2013.

The past 8 years have been preliminary tox studies.

Then this is great! We have plenty of data/results that convey the same story, over and over again: NanoCides are highly efficient and effective, non toxic with no side-effects. Moreover, why not share with the forum members the detail in the FDA protocol?

NanoViricides says pre-IND meeting with FDA for FluCide "successful"

The company, with guidance from its regulatory consultants at the Biologics Consulting Group, Inc., had previously determined that filing a pre-IND was important at this stage in order to understand potential FDA-required studies prior to filing an IND.

"Because of the novelty of the technology and approach, we requested this pre-IND meeting even before performing certain customary safety/toxicological studies," NanoViricides said in a statement.

"We believe that the guidance we received goes beyond FDA guidance documents, and is more specific for our drug candidate, NV-INF-1.

"The company will now plan and execute the studies identified based on this meeting."

source: http://www.proactiveinvestors.com/companies/news/27192/nanoviricides-says-pre-ind-meeting-with-fda-for-flucide-successful-27192.html

Milestones -
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013

FluCide, which is based on a completely new mechanism of action, is based on the company's nanoviricide technology, the combination of a nanomicelle - a biodegradable, non-toxic polymeric-based structure - that is then attached to a "ligand".

“No failures in 5,000 animals….We are agnostic as to the host.”, “As long as you have a virus in your circulation, we destroy it.”, “Multi-billion dollar market cap? Oh, easily.“ ~ Dr. Seymour

"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, Nanoviricides, Inc. CEO. Why would Dr. Seymour state this if the schedule of events is, to some extent, controlled by the FDA? This is the Nanoviricides, Inc. point of view that I believe has been presented to the FDA.

Dr. Seymour said, "...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..."

"The design of the studies was reviewed by the FDA in a pre-IND meeting, as previously announced by the Company.

The Company has previously reported successful results of the Company’s FluCide™ drug candidates in pre-clinical animal studies using two different phylogenetically distinct types of Influenza A, viz. H1N1 and H3N2. The Company has also reported that the drug candidates have been found to be extremely safe in these animal studies. The Company intends to conduct additional efficacy studies as required for the IND application in parallel with the safety/toxicology studies." ~ BUSINESS WIRE

"IMO, the biggest thing, Anil was able to develop the MERS solution in less than a week. Less than a week for the type that will be tested in EU is pretty amazing and beats the 3 weeks of the rapid in field technology they previously talked about."~ BigKahuna

What happens when the FDA starts seeing the same successes, no toxicity, no side effects, same results as those in the past, if not better! Do we need another 8 years of the same?

Do I have reason to be optimistic? Yes. Once Nanoviricides, Inc. receives initial results of toxicology studies for FluCide (4Q 2013) from BASi and key collaborators they will start to prepare IND for submission to regulatory authorities (4Q 2013).

WHAT IS TOXICOLGY?

Toxicology is closely related, studying the harmful effects of chemicals, natural products, or drugs.

A Pharm-Tox Study will refer to any type of study that seeks to determine the therapeutic and / or toxic effect of a drug using in vitro or animal studies.

In vitro refers to studies that are performed in the laboratory without the use of live animals or humans. Many times these studies involve cells or tissue grown in the laboratory.

In vivo studies refer to studies performed in live animals. Clinical studies refer to studies performed in humans.

Therapeutic Dose. The therapeutic dose is the amount of drug that provides the optimal beneficial effect. Something that is beneficial (or even essential) at one dose can become toxic at the wrong dosage. By combining in vitro studies and animal testing, Pharm-Tox studies hope to predict a drug dose that is both safe and effective before it is given to humans.

WHEN SHOULD TOXICOLOGY STUDIES BE PERFORMED?

The Pharm/Tox studies are a bridge that helps justify the use of the drug in humans and estimate the dose and dosing schedule for humans receiving the drug.

DO SIDE EFFECTS IN PHARM/TOX STUDIES MEAN THAT A DRUG CANNOT BE ADMINISTERED TO HUMANS?

Pharm/Tox studies are designed to determine the short and long-term side effects from a drug. Just because a drug has some side effects does not mean it cannot be used in humans. The FDA and the developer of the treatment must agree that the known or potential risk of a treatment is outweighed by the potential benefit (i.e. the risk: benefit ratio). For example, if a drug caused temporary hair loss it would not be acceptable as a new treatment for headaches. In contrast, chemotherapy that is used to treat cancer often causes hair loss but the risk of that side effect may be acceptable to a patient due to the serious nature of the cancer. What is required is disclosure of that risk to the patient so they may make an informed consent about whether to receive the treatment. There is a legal requirement for information about known or potential side effects to be disclosed, regardless of whether the treatment is investigational or already approved by the FDA.

WHO DECIDES IF A DRUG IS SAFE TO ADMINISTER TO HUMANS?

Once Pharm/Tox studies have estimated the potential side effects associated with a drug, the Sponsor must interpret the findings of the Pharm/Tox studies. If they believe the risk: benefit ratio favors moving the drug to human clinical trials they must complete an Investigational New Drug Application (IND) and submit this to the FDA. In the IND, the investigator must justify why they believe the Pharm/Tox study supports moving the drug into the clinic. They must also provide the detailed reports from the study for the FDA to review.

The FDA will then review the results presented in the IND and make an independent determination as to whether it is reasonable to begin a clinical trial to study the drug in humans. If the FDA has questions after reviewing the IND, they can place the clinical trial on hold until the questions are resolved. The FDA is also free to audit the records of the Pharm/Tox studies and samples from the study must be maintained for FDA review.

For human clinical trials, an independent Institutional Review Board that serves to protect patients from risks associated with research must also review the study. The function of this Board is described in the Code of Federal Regulations and must assess the risk, monitor the conduct of the trial, and ensure patients give informed consent before treatment can begin.

WHAT SHOULD SPONSORS CONSIDER WHEN DESIGNING A PHARM/TOX STUDY?

When developing a drug for human use, one must consider how the drug must be given to maximize effectiveness. For example, will the drug be given as a one-time dose, or will it be given repeatedly over many years? Knowing how much, how often and for how long a drug will be given are critical questions when designing a Pharm/Tox study. Since Pharm/Tox studies can be very expensive, it is well worth the effort and expense of performing preliminary experiments aimed at identifying the potential dose and dosing schedule to be used in the Pharm/Tox study so the optimal information is collection to support the dose that will be used in humans.

A Sponsor is also well advised to develop a Pharm/Tox study with input from the FDA prior to initiating the study. The Sponsor should carefully determine what critical studies are required then contact the FDA to discuss the proposed Pharm/Tox study. It is better to identify concerns from the FDA before the costly and time-consuming Pharm/Tox study is initiated to minimize the chance that the study will be inadequate or insufficient to support the IND.

There are a number of options for discussing drug development with the FDA. A Pre-Pre IND call is an informal, non-binding discussion that allows the Sponsor to provide the basic premise and supporting results that warrant drug studies in humans. A Pre-IND meeting is a more formal meeting in which the Pharm/Tox studies and the proposed clinical trial design will be discussed with a variety of FDA officials. In both cases, the FDA may make suggestions regarding the design of the Pharm/Tox study. Additional studies, or study modifications, are not uncommon and is why the FDA should be approached prior to conducting the study.

WHAT ARE SOME SPECIAL CONSIDERATIONS WHEN DESIGNING PHARM/TOX STUDIES?

Many drugs can cause birth defects if given during pregnancy, so drugs that may be taken in women of childbearing age may require special testing. Children metabolize drugs differently than adults, so drugs that will be administered to children will likely require special testing. Importantly, certain classes of drugs that increase the risk of cancer causing mutations will require special risk assessments.

WHO PERFORMS PHARM/TOX STUDIES?

Pharm /Tox studies are generally not performed in research laboratories but conducted in specialized centers with specific expertise in these studies. In general, Pharm/Tox studies are conduced under Good Laboratory Practices (GLP). The requirements for GLP work are described in the US Code of Federal Regulations (21 CFR part 58).

source: https://www.ngvbcc.org/PharmToxTutorialBasics.action