Intercept Pharmaceuticals (ICPT)

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KaBOOM!!! Why is this important? Please, consider this...

The stock of a little-known biotech company, Intercept Pharmaceuticals Inc., ICPT +59.89% nearly quadrupled Thursday after the company's liver-disease drug performed well in a clinical trial, marking the biggest one-day stock leap among Nasdaq Composite companies of a similar size since at least 2012.

Shares of New York-based Intercept—which has 45 employees and no products on the market—closed Thursday at $275.87 on the Nasdaq Stock Market, valuing the company at $5.3 billion. On Wednesday, the stock closed at $72.39 with a market capitalization of $1.4 billion.

That's the largest one-day jump among Nasdaq Composite companies with market values of over $1 billion since at least 2012, according to FactSet Research Systems Inc.

The drug, called obeticholic acid, or OCA, mimics a naturally occurring human bile acid that Intercept believes has liver-protective properties. The National Institute of Diabetes and Digestive and Kidney Diseases sponsored a clinical trial of the drug in patients with a condition known as nonalcoholic steatohepatitis, which involves fat accumulation in the liver that can cause inflammation and lead to the more serious conditions of cirrhosis and liver failure. The disease progresses over many years and often has no symptoms in the early stages.

There are no specific therapies for the disease, which affects 2% to 5% of Americans, according to the National Institutes of Health. Instead, physicians often recommend patients lose weight if they are overweight, improve their diets, exercise, and avoid alcohol and unnecessary medications.

source: http://online.wsj.com/news/articles/SB10001424052702304347904579310212798133916

NanoViricides, Inc. is a very frugal company, has 5 employees on the payroll, and is on-track to clinical trials this year (2014) with their first broad-spectrum therapeutic drug against Influenza, FluCide. In the United States, each year on average 5% to 20% of the population gets the flu and more than 200,000 people are hospitalized from seasonal flu-related complications. Antiviral medicines that are used to treat or prevent the flu include oseltamivir (Tamiflu®) and zanamivir (Relenza®) and they are 40% - 60% effective against the flu. Two other antiviral medicines, rimantadine (Flumadine®) and amantadine (Symmetrel®), were used in the past but are generally no longer effective because most flu viruses are now resistant to them.

Think of going to a clinic with flu symptoms, being diagnosed and prescribed a broad-spectrum FluCide. We expect efficacy studies/results that would confirm near-eradication of the virus and the symptoms in a matter of hours! Yes, that would be very nice. No complications, due to life-threatening virus, requiring hospitalization, would then be experienced. Cost of health insurance...down? Think of a low-toxicity therapeutic drug for children, for those with compromised immune systems, for all human kind, regardless of age. Possible?

NanoViricides, Inc. is being thorough and is on the move!!!

WEST HAVEN, Conn.--(BUSINESS WIRE)--Jul 23, 2012 - NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials in Australia for Flucide™, the Company's broad-spectrum anti-influenza drug. Australian Biologics will also facilitate clinical trial site(s) selection and development of the clinical trials agreements.

source: http://www.drugs.com/clinical_trials/nanoviricides-retains-consulting-firm-expedite-first-flucide-human-trials-australia-14091.html

Nanoviricides is the shifting paradigm of antiviral drugs. Notice that ICPT drug successfully interacts with the host cells to heal/improve on a condition of a vital organ, the liver. The now optimized FluCide candidate (as well as other drugs in the NNVC's pipeline) is agnostic to the host. FluCide will not care if you are young or old, a whale, a cow, a mouse, a salamander...a bee? If the host has a life-threatening virus, it destroys it, along with the debilitating and painful symptoms, in a matter of hours.

WEST HAVEN, Conn.--(BUSINESS WIRE)--

NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") reports that it has received results of detailed lab analysis studies from the initial non-GLP toxicology studies of intravenously administered FluCide™. No overt adverse safety and toxicology effects were observed in this study of the Company’s optimized FluCide broad-spectrum anti-influenza drug candidate, even at the maximum feasible dose level. These results are consistent with the preliminary findings of this study that the Company has previously reported, and provide greater details of the safety of FluCide.

source:http://finance.yahoo.com/news/nanoviricides-inc-reports-excellent-safety-120000657.html

As you all well know, nothing is static in market economies. As NanoViricides, Inc. progresses on-track to clinical trials, and progress is communicated via PRs, I believe pps could very well climb a lot higher. Just like ICPT, first $30 pps and higher, around $70 pps. Who knows, maybe $100 pps. Does that sound good? It does, IMHO.

NanoViricides, Inc. should request and should be granted designation of breakthrough therapy FAST TRACK (good for flying horses) by the FDA once the GLP evidence/report on "tox studies" is presented by Bioanalytical Systems, Inc., Indiana. However, it may not be necessary because a virulent disease like Influenza may last a week or two weeks. We should see an explosion in pps, or KaBOOM. around first quarter of 2015!!! You ain't seen nothing yet!!!...but we will this year and next...and the following years!!! Think of the possibilities...it is transformational nanotechnology.

more on FDA breakthrough therapy designation: http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm341027.htm

more on BASi and NanoViricides, Inc: http://www.businesswire.com/news/home/20121113005322/en#.UtGatfutY1c

Once NanoViricides, Inc. gets its first FluCide candidate through clinical trials, FDA review, DengueCide (for Dengue) and HIVCide (for HIV) are likely to follow-through in short order.

more here: http://www.proactiveinvestors.com.au/companies/news/44138/nanoviricides-flucide-a-potential-cure-for-the-flu-drug-to-enter-human-trials-next-year-44138.html

...Dr Seymour was asked about their platform technology to rapidly create anti-viral drugs and how it related to HIV/AIDS and other viral diseases. He explained the construction and function of their line-up of drugs all work on the same basic principle. A nanomicelle that is a 20 nanometer polymeric-based structure attached to a "mimic" of the receptor protein that sits on the host cell that is then used to lure the virus to the cell. For example; Influenza is a virus that causes the illness known at "flu." If you can at least control, or better yet, destroy the virus in the bloodstream, you can reverse the symptoms of the illness, allowing the patient to recover quickly.

source: http://online.wsj.com/article/PR-CO-20131223-905949.html

more on the technology: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=91812469

"...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..." Dr. Eugene Seymour, CEO Nanoviricides, Inc.

"...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, CEO Nanoviricides, Inc.

Important bits and pieces of NanoViricides, Inc. PRs...

NanoViricides, Inc. Reports Excellent Safety Profile of Its Broad-Spectrum anti-Influenza Drug Candidate, FluCide(TM) , in a Non-GLP Study.

As previously reported, the results of this study will provide both the basis and focus for the GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These GLP studies will be performed on both large and small animals at the BASi facility in Indiana.

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 lab 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.

What are the potential Q1 2014 catalysts:

1- Start-up of Toxicology and Safety Studies by BASi

2- Start-up of efficacy studies of the FluCide candidate, Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI), incl. H7N9 and MERS

3- Completion/commissioning of cGMP Pilot Plant

more on cGMP Pilot Plant/efficacy studies:
http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Reports%20on%20Construction%20Progress%20of%20its%20New%20Facility%20and%20cGMP%20Pilot%20Production%20Plant.html

From the "good doctors" at NanoViricides, Inc.

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

The Company is: NanoViricides, Inc. (NNVC) ---- http://nanoviricides.com/