by Travis Johnson, Stock Gumshoe | February 24, 2014 2:50 pm
The phrase “Alzheimer’s Disease” sets off an almost pavlovian response among investors … we all know that Alzheimer’s is probably the least-understood major disease, and affects a spectacularly huge number of people, and even those who don’t get beyond fifth grade math can do the calculations: more than five million Americans have the disease, and that number continues to rise, people are living longer and already a third of senior citizens who leave this mortal coil have Alzheimer’s or some other form of dementia[1] at the end of their lives. That’s a LOT of potential patients.
And they have almost nowhere to turn — there are a few approved drugs[2] that help some patients with some of the symptoms of Alzheimer’s, particularly memory loss, but they don’t do anything to cure, prevent or reverse the disease. That’s the golden ticket for pharmaceutical companies, but the search for cures has also burned many big pharma companies and sent quite a few little biotechs into death spirals — there’s still plenty of debate about exactly what causes Alzheimer’s, the trials are expensive, and many companies have spent millions of dollars (or hundreds of millions) only to find out that their compound had dangerous side effects, or was ineffective.
Some of the big pharma companies have effectively given up on the disease for now, but there are still a half dozen heavyweights pushing through clinical trials — mostly for BACE inhibitors, which are designed to stop the formation of amyloid plaque (the most likely cause of Alzheimer’s, according to many but certainly not all scientists). Other BACE inhibitors have failed, but hope springs eternal — and there are also, as Doc Gumshoe noted in a brief update a few months ago, more than 1,000 clinical trails going on in Alzheimer’s disease (that includes treatment protocols and devices as well as drugs, but there are a lot of drugs).
Which is a long way of saying that yes, Alzheimer’s is probably the largest underserved market in medicine. And has been for longer than Stock Gumshoe has been around (that’s seven years now). Every time any halfway appealing Alzheimer’s drug enters clinical trials, investors jump on the story … especially when it’s a smaller company (“Pure play” biotechs are always sexier because they offer more ridiculous upside — Merck (MRK)[3], for example, has a Phase III drug in trials now that is generating some hope … but even an anticipated market of perhaps $5-10 billion for their drug by some analysts doesn’t have people lusting after the stock, given Merck’s $160 billion market cap and $44 billion in sales last year).
And the stock being teased as an Alzheimer’s pick today by Alex Daley[4] at Casey[5] Extraordinary Technology is, indeed, a relatively small company with an Alzheimer’s drug in clinical trials. And no, it’s not the tiny one that was teased several times in 2010 and 2011 (that was Anavex Life Sciences, AVXL, which was around $3 when first teased and is now down around 25 cents… their lead drug is now “Anavex Plus” and is a cocktail of their lead compound, Anavex 2-73, mixed with Pfizer’s Aricept (the current far-and-away leader in Alzheimer’s symptom-attacking drugs).
So what is it? Here’s the intro which provides the first couple of clues:
“We’ve just uncovered an amazing story about one man’s recovery from one of the world’s most dreaded… and expensive… diseases. His groundbreaking drug treatment could soon become widely available and dominate a $604 billion medical market.
“And in March 2014, the entire world will find out why. The payoff to you could be astronomical… with triple-digit gains possible in one day….
“It’s no wonder the National Institute on Aging calls this disease a ‘looming health epidemic.’
“And the few drugs on the market that treat this disease—approved more than a decade ago—only target the symptoms of this degenerative brain disease and not the underlying cause.
“Yet, even with their limited effectiveness, their combined sales last year topped $6 billion, according to BCC Research.
“Analysts estimate that a treatment that targets the cause of the disease itself could generate sales of $20 billion or more.
“As you probably know by now, the disease is Alzheimer’s.
“ABC News recently reported that it’s ‘…the only one of the top 10 causes of death in America that cannot be prevented, cured or even slowed down once it begins.’
“But that’s about to change…
“Because in March 2014, one little-known biotech will release its biggest clinical results yet on a groundbreaking new Alzheimer’s treatment that could forever change the course of this terrifying disease.
“It’s the first treatment ever to target the cause of Alzheimer’s… rather than just relieve the symptoms.”
And we get a glowing endorsement from one of the patients who was apparently in the clinical trial:
“One Red Capsule Gives Walter His Memory… And Life… Back….
“Once a day he was given a red capsule—developed by this fledgling biotech—and within the first month, his memory started to return.
“He started to remember little things like where his favorite cup was.
“According to the investigator who’s overseeing the clinical trial, Walter’s improvement was simply ‘incredible.’
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just click here...“And over the next 14 months, he became a poster child for success in clinical trials.
“Walter and his wife were elated. Walter called the breakthrough treatment ‘a godsend,’ and his wife called it ‘amazing.'”
So there we have it — the promise from Alex Daley is that he has identified a stock which will report some kind of clinical data next month, and has shown progress in at least some patients, and it’s a smallish company which would presumably feel a strong impact from whatever the results of that clinical trial might be. Big potential market, large near-term catalyst — the kind of stuff that gets traders very excited … especially when you happen to be in the midst of a biotech bull market, as we are now (or a biotech bubble, if you want to be more cynical).
And just to make sure we dot the i’s and cross the t’s, let’s see what other details Daley provides for this secret pick:
“You Could Make Life-Changing Gains From This Breakthrough Alzheimer’s Discovery
“Deutsche Bank estimates the market for this company’s breakthrough Alzheimer’s treatment could be worth $20 billion annually.
“So we’re looking at a tiny biotech—$485 million market cap in early February—that’s set to dominate a $20 billion drug market with a one-of-a-kind, patented breakthrough treatment.
“Even if it only captured a small 20% of this enormous potential ($4 billion), this booming biotech’s possible projected value would be enormous. If the company traded at just 1x its annual sales—well below the typical industry multiples of 2.5x to more than 5x—its shares would trade at about $98.
“As I write you, the stock’s price is hovering around $11.28 per share; that’s a massive 769% potential gain from this tiny biotech that’s extremely undervalued at its current price.”
So who is it? Well, we did haul out the Mighty, Mighty Thinkolator on this one just to be certain of our match … but this is 99% sure to be Prana Biotechnology (PRAN), the current market darling small cap stock in Alzheimer’s. The company has been mentioned in reader comments a few times over the past year, including from some folks who likely enjoyed nice returns as it climbed dramatically last year (it was around $2 a year ago, climbed to $12 last month, and is now back down around $9).
Their basic science is being used to attack both Huntington’s Disease (the clinical trial is called the Reach2HD trial) and Alzheimer’s Disease (the IMAGINE trial). The Huntington’s results last month were apparently good (though there’s some debate), and investors are very eagerly awaiting the IMAGINE results that are expected to come out sometime in March. If I begin to talk about the science, I’ll instantly start to sound uninformed … so I’ll avoid that entirely and just say that this is not the same path that the BACE inhibitor drugs (like Merck’s, etc.) are treading, they’re instead essentially targeting metals in the brain as a cause of neurological disorders.
We have been hosting an incredibly long discussion thread on other biotech stocks that grew organically out of a prior teaser article, and in that thread Prana came up along with several other “hot topic” stocks in biotech — so you can see the comments of some of our more knowledgeable readers there, including from biocqr here[6], karmaswimswami here[7] (Karma was responding to Frenchy’s question about Prana, here[8]). I imagine all those folks probably know more about the stock than I do.
For outside thoughts on Prana, there’s been a huge surge of interest at SeekingAlpha with both strongly negative and positive opinions — which tends to happen with most biotechs or rapid growers. This piece[9] and this piece[10] recently caught my eye as being pretty well thought-out, though I don’t know if they’ll end up being correct. On the flip side, Adam Feurstein over at TheStreet has been generating piles of hate mail for himself by writing a series of negative or cautionary articles about Prana over the last week (one example here[11]).
So yes, if Prana can cure Alzheimer’s they’ll become a multi-billion-dollar company. But there’s plenty of skepticism out there about whether that can happen or not, and I don’t know whether the FDA[12]’s new guidelines that they’ll accept limited proof of efficacy will have any impact on the multi-year safety studies that would likely be required before approval… but there will be news next month that provides at least a little more ammunition for either the bulls or the bears (or maybe, given the Huntington’s results, both). I’m sure there are at least dozens of folks here who know far more about this stock than I do, so feel free to chime in and share your thoughts with a comment below.
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to Phil Diamond: yes we know all about Benitec. I have been touting it here since last year. Please go to the other thread in Gumshoe.
I am new to the biotech area and my father-in-law that I am very close to is suffering with Alzheimers. Are the statements that Casey Research makes about Walter Lewis and others gaining their memory back after taking this drug really true? Are these facts somewhere besides in Casey’s ad?
The quotes are real, apparently, from an Australian news program — but Alzheimer’s is a very hard disease to study, as I’m sure you’re aware, in part because so much that is studied when testing drugs are results that are subjective or “squishy” data (ie, self-reported or family-reported improvements in memory or executive function), not simply chemistry changes in the body. I haven’t seen a transcript of the actual program, but a book about this “metal brain” stuff is available in part here in Google books, including the quotes used in Casey’s and other articles: http://books.google.com/books?id=OGXGAgAAQBAJ&printsec=frontcover#v=onepage&q&f=false
Hi everyone, simply making my initial entry:)
I believe a much safer betfor growth is in lo term care l. These deseases are not finding cure. Bsby boomerd are retiring and nursing homes are filling up as fast as they csn be built. In fact during the housing frrrze on lending a few years back these places where the only things be built. At least herein my neck of the woods.
I read the Phase II results and they don’t provide the success assigned to the hype.
Intermune on the other hand had a real push to day. Whether the 50-75K patient base is worth the valuation only time will tell.
So, ginseng and special foods are special for Alzheimer’s because they are anti-oxidants? I don’t think so. Those foods are tiddlywinks in reductive potential. Once again, natural/alternative belief system has it in for facts and data and trials. For drugs because they are made in a “laboratory” and not natural. If the peroxynitrite theory had any credibility at all, arginine would totally ruin cognition in Alzheimer dementia by acting as a donor for NOS, and yet it seems to help.
People get confused because endothelial nitric oxide in itself is generally helpful (improves bloodflow, for instance). However, the oxidation of BH4 (a cofactor for nitric oxide production) by peroxynitrites results in the “uncoupling” of endothelial nitric oxide synthase resulting in the production of superoxide anions instead of endothelial nitric oxide.
Nitric oxide (NO·) is an important protective molecule in the vasculature, and endothelial NO· synthase (eNOS) is responsible for most of the vascular NO· produced. A functional eNOS oxidizes its substrate L-arginine to L-citrulline and NO·. This normal function of eNOS requires dimerization of the enzyme, the presence of the substrate L-arginine, and the essential cofactor (6R)-5,6,7,8-tetrahydro-L-biopterin (BH4), one of the most potent naturally occurring reducing agents. Cardiovascular risk factors such as hypertension, hypercholesterolemia, diabetes mellitus, or chronic smoking stimulate the production of reactive oxygen species in the vascular wall. Nicotinamide adenine dinucleotide phosphate (NADPH) oxidases represent major sources of this reactive oxygen species and have been found upregulated and activated in animal models of hypertension, diabetes, and sedentary lifestyle and in patients with cardiovascular risk factors. Superoxide (O2·−) reacts avidly with vascular NO· to form peroxynitrite (ONOO−). The cofactor BH4 is highly sensitive to oxidation by ONOO−. Diminished levels of BH4 promote O2·− production by eNOS (referred to as eNOS uncoupling). This transformation of eNOS from a protective enzyme to a contributor to oxidative stress has been observed in several in vitro models, in animal models of cardiovascular diseases, and in patients with cardiovascular risk factors. In many cases, supplementation with BH4 has been shown to correct eNOS dysfunction in animal models and patients. In addition, folic acid and infusions of vitamin C are able to restore eNOS functionality, most probably by enhancing BH4 levels as well
The key to the prevention of Alzheimer’s disease is to sufficiently inhibit the pathways that lead to the production of peroxynitrites via NADPH oxidase (superoxide anions) and inducible nitric oxide synthase(inducible nitric oxide).
J Exp Med. 2005 Nov 7;202(9):1163-9. Epub 2005 Oct 31.
Protection from Alzheimer’s-like disease in the mouse by genetic ablation of inducible nitric oxide synthase.
Nathan C1, Calingasan N, Nezezon J, Ding A, Lucia MS, La Perle K, Fuortes M, Lin M, Ehrt S, Kwon NS, Chen J, Vodovotz Y, Kipiani K, Beal MF.
Author information
Abstract
Brains from subjects who have Alzheimer’s disease (AD) express inducible nitric oxide synthase (iNOS). We tested the hypothesis that iNOS contributes to AD pathogenesis. Immunoreactive iNOS was detected in brains of mice with AD-like disease resulting from transgenic expression of mutant human beta-amyloid precursor protein (hAPP) and presenilin-1 (hPS1). We bred hAPP-, hPS1-double transgenic mice to be iNOS(+/+) or iNOS(-/-), and compared them with a congenic WT strain. Deficiency of iNOS substantially protected the AD-like mice from premature mortality, cerebral plaque formation, increased beta-amyloid levels, protein tyrosine nitration, astrocytosis, and microgliosis. Thus, iNOS seems to be a major instigator of beta-amyloid deposition and disease progression. Inhibition of iNOS may be a therapeutic option in AD.
Activation of microglial NADPH oxidase is synergistic with glial iNOS expression in inducing neuronal death: a dual-key mechanism of inflammatory neurodegeneration.
Once this point has been passed, the key to treating Alzheimer’s disease is with peroxynitrite scavengers.
Au contraire about ferulic acid, syringic acid, and vanillic acid in heat-processed ginseng being inferior antioxidants. Along with curcumin and eugenol, these methoxyphenols are the best peroxynitrite scavengers because they are ready donors of hydrogen protons and electrons. They bring about the following conversion: ONOO- (peroxynitrites) + 2H+ + 2e-= H20 + NO2-. This is why methoxyphenols in human clinical trials have shown significant positive effects on cognition and in some cases in behavior in people with mild to moderately severe Alzheimer’s disease.
It is very difficult to treat a disease unless you know its cause. Once you know its cause, the confusion ends and the progress begins.
Up 24% today,
So, should we sell? Or keep this stock?
Proof is in the pudding; up 25% in 2 days. Will sell in May and go away.
There was a big study in the Netherlands.
Conclusion, arteriosclerosis is the cause for dementia.
Science journalist Kirsten Emous, wrote a book about it.
De doolhof van tante Anna.(The labirinth(maze) of aunt Anna)
I did not read it yet. Maybe someone can translate it.
How do you argue with a belief system? If that’s how you wish to invest suit yourself. A mathematical case could be made that the ingestion of “nutriceuticals” [vitamins,supplements] causes alzheimers since the rate of use vs. disease increase is similar. Similar to truism “everyone who habitually ingests Dihydrogen oxide dies.”
Personal view is that DNA deterioration is the main cause; we are all copies of copies of copies etc. & alzheimers does ‘run in families’. Also general aging of population means increase of geriatric problems. On the other hand; hucksters who sold snake oil did make money.
“Science adjusts its views based on what’s observed. Faith is the denial of observation, so that belief can be preserved.”
Tim Minchin (again)
For those looking for an alternative medicine for alzheimer’s disease I suggest you study this link carefully.
http://www.neuroanatomy.wisc.edu/selflearn/Nuns&alzheimers.htm
1] Nuns don’t retire.
2] Few drink excessively
3] But those nuns that were educated well by their parents did not manifest the disease during their life time. If you want your kids to not manifest this illness educate them well
For yourself learn a new foreign language. Take classes at local community college.
By the way I am a neurologist that runs a free medical clinic.
http://www.neuroanatomy.wisc.edu/selflearn/Nuns&alzheimers.htm
What about Mercury? I have a mouthful of amalgam filled teeth which would cost a fortune to replace.
It is very interesting that Casey mentioned March test results. Before Gumshoe did this article, I had researched what stock Casey could be talking about. I came up with two stocks in Alzheimer’s drug development that have results coming out in March, Prana and Anavex Life Sciences AVXL. So I bought both. Since I bought them and as of Friday’s close, PRAN is up 24% and AVXL is up 18%. AVXL was actually up over 50% earlier in the week. Does anyone know about AVXL and whether some analyst promoted them this week? Or perhaps there were others like me that thought Casey may be referring to them.
Is it what you eat or what you swallow, could it be how long you sleep or are awake, what is digested and what stays, everything has a piece of life. But a proven smile that is real and shared with others not if but when they meaning whoever slows down and cures what we will all naturally have unless something unfortunate happens. Let them work on the cure but the cure is living with what you are the best way you can. That I would invest in but there is no that without you. Make a difference and you will remember although it could be good or bad it will be a difference. One must remember that there are cures for disease that keep you around long enough to get other diseases, that is contagious, believing in the Gumshoe is reality and there will always be ups and downs and it is said and proven you can profit from both but a straight line can be taken many ways , take a chance with a stop can stop you from winning going up or down but will you will be around to remember. No answers here but me personally will stay clear on every step we take not the ones we are being forced to take. Good luck to all irregulars families and friends, which is what Travis has given us all an equalizer the thinkolater is this a birthday or a with out a date bubble that no one can predict but your self. I respect all those that try it is the watching and waiting for those that complain are always second in line to see if it works for the first and who said the world was flat. Thanks Travis for letting us put it or should I say value what is known to what is not and those that wait to prosper or not, that is the individuals choice or not at least you show us there is a deck of cards, and you can always ask to cut but sometimes it is better left alone. Now about that 247.00 $ for an ounce for Gold how much can one carry until they have to swim. Good article as usual let the games begin.
perhaps imagine the regen therapeutics, low light, spotlight a few, that’s right.
but the great discoveries soon!
Another Great Call by GUMSHOE….You could have made a fortune. The stock was $10 a share in February on May 20th its $1.58. Like I said, you could have made millions on this stock – BY SHORTING IT….LOL