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Friday, January 03, 2014 12:48:48 PM
1. Advanced Pre-clinical development of our Injectable FluCide towards IND filing;
2. Enabling a highly customizable pilot-scale cGMP manufacturing capability for the production of clinical study quantities of any of its nanoviricides® drug candidates and any of the various formulations of these candidates;
3. Improving Corporate Governance towards up-listing the Company on a national exchange.
The Company reported that it has been successful in advancing each of these objectives. On September 25, 2013, the Company stock was listed and began trading on the NYSE MKT national exchange.
The Company has signed a Memorandum of Understanding (MOU) with Inno-Haven, LLC, for the total renovation of the 1 Controls Drive, Shelton, CT, facility purchased by Inno-Haven into a pilot scale cGMP facility and associated R&D laboratory space. Inno-Haven is controlled by Anil R. Diwan, PhD, our founder. Inno-Haven has raised substantial amount of capital for this project through various sources, and it is expected that they will be able to raise all of the necessary funding for this project, with minimal capital expenses to be borne by NanoViricides, Inc. The Company is expected to lease the facility. The terms of the lease are expected to be negotiated after the total cost of the facility can be determined to a substantial extent. No lease has been signed yet. The project is already in construction phase, and is anticipated to be completed in the first calendar quarter of 2014, if no additional delays such as long lead times or back orders on equipment etc. are encountered.
We are currently focusing on advancing our Injectable FluCide™ drug, for the treatment of severely ill, hospitalized, influenza patients, towards an IND filing. We have also developed an Oral FluCide drug that continues to advance following the injectable version. Both of our FluCide drug candidates are “broad-spectrum”, i.e. they are expected to be able to combat most, if not all, influenza viruses, including bird flu, high path influenzas, epidemic influenzas, seasonal influenzas, and potentially any novel influenza A strains.
The Company is scaling up the production of FluCide from gram scale to several hundred grams scale. The Company believes that the scale up and reproducibility of product batches can be effectively controlled.
source: http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Files%20Annual%20Report%20-%20Reports%20Having%20Sufficient%20Funds%20to%20Advance%20A%20Drug%20Candidate%20into%20Clinical%20Trials.html
We are moving forward on the (3) objectives and we are waiting for PRs that describe how well we are progressing with BASi GLP Toxicology and Safety Studies on the FluCide candidate, among others! The first Monday of 2014 is fast aproaching! IMHO, it will be an epic NanoViricides, Inc. 2014!
Pharmacokinetics made simple
Pharmacodynamics made simple
From "the good doctor", Dr. Anil Diwan:
You are already aware that nanotechnology is all around us. Plants, bacteria, and animals use nanotechnology every day. The chloroplasts that harvest light, the mitochondria that harvest chemical energy from food for use by the cell, and all of the structures in our bodies are engineered at the molecular and nano-scale levels. In Pharmaceuticals, vaccines can be considered the very first nanotech drugs, followed by “convalescent serum” therapies, and later antibodies, enzymes, proteins and peptides. As scientific knowledge advances, scientists learn more about how to engineer new “nanomachines” that are designed for a specific task.
The beauty of nanotechnology is that it enables you to engineer solutions designed for specific problems. Attacking infectious agents or rogue, rapidly growing cells as in cancer, is one thing. Killing or destruction is always easy. We are also faced with intractable diseases caused by degeneration or destruction of cells, tissues and organs. Burns and wounds cause local destruction. Nanotechnology-based approaches have been developed and some are already in use for wound healing, and also for burn patches derived from the patient’s own cells. Parkinson’s spectrum disorders are caused by destruction of DOPA-producing cells. Multiple Sclerosis and related diseases are caused by the loss of brain cells that produce myelin which coats and shield the axons as an insulator and protective. Alzheimer’s disease is caused by loss of brain cells. We do not even know the specific mechanism that causes different forms of arthritis. Some of these diseases are being linked to infectious factors, in addition to genetic factors. Attacking these diseases will require helping the cells and tissues grow, and differentiate into the specific type of cells that were depleted. Nanotechnology will become almost the first thought when thinking of approaches for attacking such difficult problems.
Think of it this way: Long ago, humans learned to roll tree trunks. That was the first “vehicle.” Now that we have learned how to make carts, then smart carts, and cars and airplanes, are we going to go back to just the tree trunks? The nanomedicine evolution is very similar. Long ago we learned about herbal extracts. Then we isolated active ingredients. Now we are learning how to engineer these systems into cars and trucks and airplanes and drones, if you will. So I think, nanomedicine is going to be pervasive. That does not mean we need to replace aspirin with a nanomedicine form, although if the nanomedicine form gives us some better properties, we will see that as well.~ Anil R. Diwan, Ph.D., President and Chairman of NanoViricides
source: http://www.vincentcaprio.org/nanobusiness-interview-anil-r-diwan-president-chairman-nanoviricides
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