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Could be the other way sales team not performing bring in a heavy hitter wait and see
The whole FDA process is obscenely slow how can it take til 2016 to commence phase 3? That's like 18 months away
if mullens does not start picking up the pace this company is good for nothing. Scientists do not have great track histories of running companys - they should stay in the labs where they belong. The pace at which these chaps are operating on is rediculous. This company will be bust long before anatbloc gets it day in the sun. if they don't do something quick the private placement funding market will dry up. We are at 38 cents and mgmt are doing absolutely nothing to help support this. they should be expediting the FDA to resolve the query on anatabloc. They could be selling this stuff overseas if they could just get start talking to overseas suppliers. they could be selling anatbloc to ecig companies - would only take a few calls as there are an abundance of companies dying to have a eliquid that differentiates from the masses. in relation to the tobacco patents they could buy a manufacturing plant and start selling safe cigs. All this potential and these guys just flounder.
Seriously losing patience with this company
Anyone have any idea how long the phase 3 trial will last
Shame today would of thought INO news would of rolled over to ONCS more validation of electroportation
can someone please explain to me why we need to do trials for this from scratch considering we are using existing FDA approved medicines but applying them with a diffrent delivery system i.e. elctroportation. Surely we can jump straight to phase 3 - we know the toxicity and effectiveness.
Lastly why are they ignoring the whole international market all they need to do sign up some agents to distribute. International clients getting shafted in us freight and customs these are low hanging fruit. We have 27 million short shares mgmt need to take care of burn and funding sources before then hoping that a jv will be secured we are in a particularly sad state of affairs and just hoping that a large pharma will jv with us. See this time and time again with small caps they go under before their product gets FDA approved with a 50 cent stock price we have limited pp left until we are diluted into oblivion. Big pharma will just bear raid and pick this company up for cents
I know it's pathetic how slow mgmt are now. Time release ecig tobacco curing patents.......we need someone who is more productive and doesn't take close to 12 months just to decide what path they will take through medical trials. Far to painful if you ask me. Also have we had any update from the FDA yet? Probably not close my case
What ever happened to the time release abloc tabs or ecig
the you go family man
A pretty good interview of Reni Benjamin of H.C. Wainwright & Co. & his view of the current biotech market.
http://www.investorideas.com/news/2014/lohas/07111.asp
didn't realise we had some competition using same MOA. Thought we had patents to prevent this - sounds far to similar for my liking.
RB : La Jolla Pharmaceutical Co. (LJPC:OTCBB) is developing a small molecule inhibitor against galectin-3 called GCS-100. Galectins have been implicated in a variety of disease indications, and it appears that overproduction of galectin-3 leads to fibrosis in the kidney and liver. La Jolla is one of several companies addressing indications like chronic kidney disease.
What's interesting about La Jolla is that it has reported randomized control data showing a statistically significant benefit in estimated glomerular filtration rate (eGFR), which is a marker of kidney function. What the company was able to show was that GCS-100—in the lower doses, not the higher doses—seems to impact the eGFR in chronic kidney patients, and may delay the onset of dialysis. La Jolla's study involved more than 100 patients and was randomized and controlled, which should give investors more faith in the data. We're going to see the final data in all the subgroups in mid-November at the American Society of Nephrology meeting in Philadelphia. The data could be a significant driver for shares going forward.
TLSR : La Jolla is a micro cap, and on that basis alone it could give investors a healthy return. You're following another company, Keryx Biopharmaceuticals Inc. (KERX:NASDAQ), which also has a molecule, Zerenex (ferric citrate) for chronic kidney disease, that could launch this year. But the market valuation differential between these two companies is significant, with Keryx at about $1.4B, whereas La Jolla has a market cap of $65M. What justifies the vast differential in valuation between these two companies?
RB : The main difference is that Keryx has completed Phase 3 studies. Its drug is already approved in Japan and is selling as of this year; the company has a Japanese marketing partner. Keryx is currently awaiting regulatory approval in the U.S., and plans to start selling the drug by the end of the year. La Jolla has several years' worth of development left before seeking regulatory approval. The differential in market cap is primarily due to the difference in the development stages of these companies.
TLSR : Could Keryx's valuation portend something for La Jolla's valuation in the future?
RB : For now, at least, there's a better comparable. Galectin Therapeutics Inc. (GALT:NASDAQ), which I do not cover, is a more reasonable comp for La Jolla, in that it is also in Phase 1 with its drug GR-MD-02, for a slightly different indication called nonalcoholic steatohepatitis (NASH; fatty liver disease). Galectin's market cap is around $270M, versus La Jolla's $65M.
Investors need to be aware that last year La Jolla did a significant financing. This is also true for RXi. There are a significant number of convertible shares outstanding on a fully diluted basis, and readers should know that is the case for both La Jolla and RXi. If these convertibles are executed, that would lead to a higher common share count. Our valuations for these two companies take these fully diluted shares into account. While it is true that La Jolla's market cap is currently $65M, investors should realize that biotech-savvy funds hold a significant portion of the equity. If they do, La Jolla's market cap is significantly higher, probably closer to $150 M.
anyone have any idea how much longer it will take to see some revenue for the new products. i know patience is a virtue.
bet ya the chaps shorting are the guys that offerred us 10 million in financing - ISCO should investigate if this is the case and kill the agreement or prosecute them for breaking the non shorting agreement
Cheers el fonzo
Why is everything progressing so slowly they need to step it up the pace is rediculous at this pace we will never get a product to market
Why is everything progressing so slowly they need to step it up the pace is rediculous at this pace we will never get a product to market
I bet the guys that offered 10 million in pp are the guys selling this south these are the dark games of corporate finance world. Mgmt need to wake up a d smell the coffee. If we lose the ability to raise capital via pp market then we are cooked unless the revenue rises unexpectantly. I like the technology but hate the us stock market with a passion regulators are non existent. Naked shorting is a prime example of how ineffective the regulators are.
could the bear raid be associated with the expected european patent decision on HpSc. Maybe a few insiders have front run the decision - i highly doubt it - insiders are accumulating and earnings are increasing - I'm going to keep accumulating.
Why is this company progressing sooooooo slowly still no toxicity tests. Is something wrong?
Anyone have an idea on the short position and what the naked short position is this appears to be a short raid IMHO we have growing revenues and 10 million in an agreed pp. could well be these guys pushing it down so that they get more stock when isco pulls the trigger. One thing I hate about the US markets is the illegal games that get played on penny stocks especially the naked shorts SEC as a regulator is so ineffective. They acted in 2008 on bank stocks but ignore the rest of the market the SHO rule is never policed. Watch the doc wallst conspiracy to under stand how bad the problem is small caps are the real economy however the naked short hedge funds are under mining the real economy with naked shorts. I hope the south American cream sales take off and cause a short squeeze
If they are low in cash can I suggest they drop the useless PR company costing us 600k over 2 years for absolutely nothing
Also pat cox replacement got spooked on a bear raid for INO and put in a sell all order. Absolutely rediculous. I agree I don't think this guy is up to the task.
The company needs to pull finger and select targets. Why does it take sooooooo long. Regardless of target they have no cash and at 79 cents the pp market will not support this level of dilution. Things really are not looking to grand for this company. My sister has crohns and this stuff has changed her life, if she gets a flare up she pops a pill and it's gone in about 3 mins. Crohns would be a no brainer
Can someone answer this question say I brought my wife a designer handbag that had DNA markings how easy and how much would it cost me to validate the authenticity. This is in my opinion the bridge that needs to be overcome in order for this technology to go mainstream. If its not cost effective for the end user then no one in the retail industry will adopt
All dev companies loss money. I was referring to the technological comparison.
Love to know how our technology compares against originoil sounds like their technology is superior no chemicals. Both development company's both in the same position Patrick cox is backing originoil
Patrick cox replacement Stephen thingy magig just announced a sell...... Got spooked by the AF bear raid article ...... He's clearly pretty flighty not sell half sell all.... Hmmmmm bit concerned about that call. Bizarre
Drtx just got approval for absssi drug so we have some competition sure B is superior in regards to one dosage
Glta. We do seem to be in a holding pattern
I agree they should dedicate more efforts in marketing the skin creams my wife and mother are sold on the products and the margins are superb. That would change their financial predicament. A reverse split will most prob be on the cards at some stage I'm gonna quietly accumulate 2 years away this could well be a life changer plan to hold 300k shares and leave it at that glta
Enjoy we all deserve it. He trashed most p coxes recommendations apart from btx isco nnvc and INO
I shouldn't do this but what the hell we deserve a little confidence. Enjoy all
Is this a good time to invest in biotech? I’d say that de- pends on the investment, not the category, and today I’m going to violate my normal instincts and re-recommend an outlier in our portfolio.
A few weeks ago, I met with Dr. Simon Craw, execu- tive vice president of International Stem Cell Corp. (OTCBB: ISCO), in New York over an excellent tuna burger at Union Square Cafe on 16th Street, one of my favorite Danny Meyer restaurants.
I have been, to put it mildly, skeptical about the future of Craw’s employer. But two days earlier, I had a long phone conversation with Dr. Ruslan Semechkin, chief scientific officer of ISCO. The conversation was amus- ingly challenging because Dr. Semechkin has a strong but pleasant Russian accent, and telephones make all conversations between people who have different native languages difficult.
Semechkin was about to present results from experiments on African green monkeys with induced Parkinson’s dis- ease to attendees at the American Academy of Neurology in Philadelphia. Semechkin had induced Parkinson’s in the monkeys and then operated on them to inject human neural stem cells into their midbrains.
The idea was that the stem cells would be welcomed by the monkey brains and begin producing dopamine, a neurotransmitter. Dopamine is primarily associated with two things — first, as a kind of brain candy that makes you feel rewarded and plays a big part in addictions, and second, as part of the midbrain motor-control system of body movements.
Among other things, Parkinson’s patients have uncon- trollable tremors, and their body movements slow down to the point that they can become immobile. Parkinson’s afflicts more than a million Americans. Journalist and es- sayist Michael Kinsley has written insightfully about the disease, and his latest article in the April 28 New Yorker explores the often overlooked mental predicaments of Parkinson’s. It’s a fascinating read.
Semechkin told me that ISCO’s experiments with the monkeys had been a success. I won’t go into all the tech- nical details, like how you measure a monkey’s progress on certain scales, but I will tell you about a video Craw showed me over lunch.
(Craw had the cod, by the way, and was very pleased when the waiter told him it was from Massachusetts. As
a proper Brit, Craw was keenly aware that fish presented as “cod” that comes from the Pacific is not at all the same thing. “We almost fought a war with Iceland over cod,” he reminded me.)
On his iPad Air, Craw conjured up two videos. In the first, a pleasant-looking and spookily human-like monkey could barely hold a banana it was eating because of tremors. In the second, the same monkey seemed perfectly normal, happily peeling his banana and jumping around the cage as if a disease called Parkinson’s had never existed.
Now I’ll cut to the chase. If those videos are truly repre- sentative of what ISCO has been able to do, and if it lasts, and if it could work on humans, I witnessed something of a medical miracle.
First of all, everyone in the stem cell business has had
a lot of trouble, to put it gently, getting stem cells to differentiate into the cells a researcher wants, like into liver cells, heart cells or neurons. The problem is purity, because stem cells tend to retain a “memory” of what they have been. ISCO has a patented technology that was published in the journal Nature last year.
ISCO can take what is called a human pluripotent stem cell, one that can become anything, and stimulate it so it finally morphs into specific cells that produce dopa- mine in the midbrain area, where Parkinson’s works its tragedy. Although many companies can produce stem cells, producing specific cells that have high purity is a challenge, at best. ISCO seems to have control of that problem, and I am wondering why other firms are not beating down ISCO’s door for a licensing arrangement. “Actually, we have been approached by several firms for that,” Craw said.
Second, the neural stem cells implanted in the monkey’s brain did exactly as hoped. They were absorbed by the monkey brain and began producing dopamine. One can achieve that result with a drug called levodopa and/or deep brain stimulation, but it is an effect that diminishes with time.
Experiments with stem cells injected into human brains have been going on in China for some time. In most cas- es, the injections are made up of fetal tissue that happens to contain stem cells. By and large, the experiments didn’t work, but they did show later in autopsies that the effect ISCO is creating in the monkeys might last 10–15 years.
Interviewing researchers within a company about their efforts has to be taken with a bit of skepticism because they are usually true believers. That’s why they’re doing what they’re doing, and their future economics are tied to successful outcomes. But I was impressed that both Se- mechkin and Craw are not trying to oversell their work, and they’re appropriately humbled by the difficulties they face. Parkinson’s animal studies with stem cells are not new, but we may be witnessing a far better result than previously achieved.
ISCO has a long path ahead of it to prove anything.
Its next step is to get an IND — Investigational New Drug — approval from the FDA so that Phase 1 trials can begin on actual humans. Craw says ISCO should be able to get the IND application filed by early next year and get into a Phase 1 study before the end of 2015. The company already has a prominent researcher at Duke University lined up to do the Phase 1 trial on 12–15 humans. Finding volunteers that meet protocols should not be difficult. That trial is intended only to establish whether the “drug” involved creates any toxicity or side effects. If it does not, ISCO will likely be on to a Phase 2 study that establishes dosing and efficacy and compares results to a control group. But because of the nature of this particular Phase 1 study, involving actual transplan- tation of the stem cells in actual brains, ISCO will get something of a Phase 2 trial out of it too. The results on patients will be quite obvious.
Meanwhile, ISCO is hardly a well-financed company, and trials cost a fortune. I was at an ARC Fusion Dinner of about 50 biotech leaders in San Francisco two weeks ago at which tech startup genius Juan Enriquez and genomics guru Eric Schadt spoke. In a question-and-answer ses- sion following a discussion called Should We Build a Better Human? that was based largely on stem cell research, a scientist/entrepreneur in the audience noted that a typical Phase 3 study now costs $120 million. That’s five times what ISCO is worth.
International Stem Cell generates about $6 million a year from a skin cream business and a subsidiary that produces primary human cells including stem cell lines for researchers. They then proceed to lose about $6 million a year overall. That’s small change in the biotech business. The company finished 2013 with about $2.3 million in cash. ISCO has a credit line agreement that allows them to withdraw up to $10 million in exchange for stock at whatever the stock is selling for at the time. At current prices, that would create about 60 million new shares of ISCO. There are about 156 million shares outstanding.
ISCO’s dilution problems going forward are com-
pounded by its low share price hovering around 16 cents. This newsletter recommended the stock at 73 cents a share almost three years ago when it looked cheap. A year earlier, the stock sold for more than $2.50 a share.
As I’ve mentioned many times, I think penny stocks are a fool’s game, and I do not trust the transparency of stocks that do not list on a major exchange. But I also think we have an unusual situation with this company. Although the odds are very much against a company in the stem cell business succeeding with a breakthrough therapy, about one in 10 Investigational New Drug Applications to the FDA actually do end up getting through all the necessary trials and getting approval. The killer app is that they tend to fail late in the pro- cess, so the statistics for success once a drug reaches Phase 3 trials, when hopes and stock prices are soaring, are still about one in 10.
I see a lot of downside in International Stem Cell, includ- ing future dilution, but I think the company represents one of the ideas this newsletter has been built on: that most of our investments will falter but a few will become such huge hits that they will more than make up for the negative ratio. I’m more cautious about that approach than the previous editor, and I have sought to diversify the portfolio. Nonetheless, I’m willing to take a chance on International Stem Cell Corp.
So here’s my recommendation for the moment: I’d buy ISCO if it is not in your portfolio, but do not invest more than 1% of your portfolio in the stock. Or just take $160 and buy a thousand shares and assume you’ll lose it. Be careful, because this is a thinly traded company and it won’t take much buying to cause the stock to shoot up. If it reaches 20 cents, don’t buy it for now, and see if it comes back down. Then be patient — two–three years patient. The people at International Stem Cell have a shot at success, and they have a real desire to get the stock upgraded to a Nasdaq listing. That will involve a reverse split if it happens, which is likely to be beneficial to the price in the long run.
And there’s one other possibility here for investors — a buyout. The technology ISCO has developed looks mighty cheap when you could buy the entire company for $25 million.
Meanwhile, I intend to cover the trials of the company going forward.
Patty coxes replacement just wrote article on isco said its worth a punt but he was worried about dilution with current share price and cash
anyone know how much skin mgmt have in this company?
Gotta say patty cox has and incredible nack of simplifying in laymans terms
Latest update
The Life Sciences Report: Patrick, you will be speaking at the Altegris Advisors LLC/Mauldin Economics conference in San Diego later in May on the topic of investing in a transformational world. What do you mean by "transformational"?
Patrick Cox: Transformational technologies change existing paradigms by causing massive disruption—destroying old industries while creating new ones. That is what we are now experiencing: The old ways are obsolescing as new solutions emerge.
TLSR: How is this playing out in the life sciences realm?
PC: Innovations and discoveries in the life sciences are bigger than in other fields. Especially with DNA, which is an ancient system of incredible complexity and sophistication. DNA-based breakthroughs in medical research are personally valuable to most people. The new DNA-based industry aims at curing diseases and extending the healthy portion of our lives significantly.
TLSR: What transformational companies do you like in the biotech world?
PC: I am not going to give away the companies I will be talking about at the San Diego conference. But I've spoken with The Life Sciences Report previously about Inovio Pharmaceuticals Inc. (INO:NYSE.MKT). The company continues to thrive.
Inovio's approach to cancer is immunotherapeutic. Instead of poisoning the body and hoping that the cancer dies first, Inovio is developing therapies that allow the body to more effectively prevent and fight cancers. This completely disrupts the status quo; it is changing the way we model cancer, especially in terms of new diagnostics like those coming out of companies like BioTime Inc. (BTX:NYSE).
TLSR: Is Inovio engaged in trials that could be game-changers?
PC: Inovio continues to validate the approach developed by David Weiner, acknowledged as the father of DNA vaccines, and Joseph Kim, the CEO of Inovio. The value of the company's platform is evidenced by the participation of Roche Holding AG (RHHBY:OTCQX). That means that Roche's lawyers have vetted Inovio's intellectual property (IP).
"Inovio Pharmaceuticals Inc. continues to thrive; it controls a massive amount of intellectual property."
A lot of people are working on DNA vaccines. Most of them have nothing that even comes close to replicating Inovio's powerful combination of electroporation (using electrical pulses to gain entry to the cell) and sophisticated plasma constructs. And in the long run, a lot depends upon who can control the patents. Inovio is the product of the merger of the half-dozen most important pioneers in DNA vaccines, including Weiner and Kim. The company controls a massive amount of IP.
TLSR: What kinds of products are emerging out of Inovio's wealth of IP?
PC: Inovio's agricultural subsidiary, VGX Animal Health Inc., working in Australia, is developing vaccines for different mammals. Inovio's vaccine platform aims to increase the productivity and the health of organisms, as opposed to just preventing disease.
Oddly, the life sciences business has a phobia about accepting anything that is not documented by human trials. That is nonsense. If there are important DNA vaccine therapies going on with pigs, cows and horses without adverse events, then the therapy is going to work with people, too.
TLSR: One of the criticisms of the dairy industry has been the use of growth hormones and vaccines. Does Inovio's line go some distance toward alleviating that fear because it uses the body's own DNA, as opposed to inserting a sample of a disease to vaccinate?
PC: How people who hold irrational beliefs are going to react to another technological advance is always a puzzle.
TLSR: Even irrational beliefs can have market consequences.
PC: Correct, but how do you predict what irrationality will do? In the long run, productivity and profits will triumph.
TLSR: Are DNA-based vaccines predicted to be cheaper than the status quo?
PC: The status quo does not approach the same clinical targets. However, DNA vaccines are not terribly expensive. The plasmids on a large scale are inexpensive, and electroporation is not a costly technology. There is one machine and a disposable unit, so the production cost is not significant. These are pharmaceutical products, so the production cost does not really matter, as the prices are market-based.
TLSR: I notice that Inovio has a preclinical study for a vaccine that protects against the Ebola and Marburg viruses. Are these diseases spreading out of Africa?
PC: Ebola is threatening the world. It is just a question of time before it will show up in New York City, Hong Kong and London.
TLSR: Through bioterrorism or hitchhiking?
PC: Probably hitchhiking, though bioterrorism is always a concern. That is why the Defense Advanced Research Projects Agency is very concerned about Ebola as a weapon of bioterrorism. But birds and pigs are terrorists, too, in that sense. Ebola epidemics are inevitable.
TLSR: What about influenza? What has Inovio done on that front?
PC: In the long run there will be an influenza vaccine, and Inovio will probably have it. There are other approaches to curing the disease, however. At the San Diego conference, I will cover some disruptive, transformational technologies for dealing with influenza that have nothing to do with DNA vaccines.
TLSR: You recently wrote about Bill Gates' malaria initiative as accelerating the Inovio vaccine development program. Can you speak a little bit about that?
PC: Gates and the PATH Malaria Vaccine Initiative do not hand out grant money dumbly or casually. The foundation's choice of Inovio as a developer of an antimalarial vaccine is important. Inovio will almost certainly succeed in developing a vaccine for malaria. PATH will own the rights to use this treatment for humanitarian reasons where malaria is endemic, so Inovio will own a traveler vaccination that may be free inside Africa. But tourists and travelers will have to pay for the vaccination before visiting Africa.
TLSR: Inovio seems to have a number of irons in the fire. What else attracts you to the firm?
PC: I am very interested in the potential market for Inovio's human growth-hormone-releasing hormone (GHRH). Aging movie stars go to high-end clinics for injections of growth hormone. It is widely used in bodybuilding and weightlifting sports. And it works. People who use growth hormone see their skin become younger, their muscle strength increase. There is an approved growth hormone product for AIDS victims. And it helps with body fat.
TLSR: How so?
PC: The reason that older people have large guts is because their growth hormone levels fall as they age, and, as a result, people end up with stubborn intra-abdominal fat, belly fat. But inject growth hormone and the rubber tire deflates! The problem with using growth hormone, however, is that it has side effects. I would not take it. I can understand why an actor who makes millions of dollars a movie may want to look younger, or why an athlete whose multimillion-dollar career depends on performance would use these expensive products. But for the average person, the cost and risk of injecting growth hormones is probably too great, mostly because an exogenous increase in growth hormone levels fundamentally upsets the regulatory axis in the body.
"The old ways are obsolescing as new solutions emerge."
On the other hand, we know from testing animals inoculated with DNA-based growth hormones that an inoculated body begins to produce growth hormones all by itself. In which case, there are no side effects. Aging baby boomers are going to demand access to a growth hormone vaccine like this when it becomes known. This is part of the long-term potential of DNA vaccines. It's much greater than cancer. At the moment, Inovio is not actively developing this therapy for humans (it is approved in Australia for use in swine). But it represents the depth of the company's platform.
TLSR: When a company makes a transformational breakthrough, such as in DNA vaccines, does this strengthen our economy?
PC: The macroeconomic drivers in life sciences are tied to the radical increase in life span that has taken place very recently. Since the American Revolution, life spans have more than doubled. In my lifetime, the average life span has increased by more than 30 years. We still have a social service model instituted when birth rates were high and life spans were relatively short. In 1950, just before I was born, I think there were about 16 workers for every retired person. Today, it's fewer than three working persons per retired person. Moreover, healthcare costs go up as we get older. Alzheimer's disease and heart disease are incredibly expensive to treat and live with. When people lived to 65 on average, those diseases were not particularly evident.
TLSR: Does Inovio have anything in the pipeline that looks at Alzheimer's?
PC: This is an innovative company, and it is looking at all kinds of things. There is nothing in current development, but I've discussed the possibility with the company. It's a longer-term potential application. Several other companies are on track for dramatically delaying, but not curing, Alzheimer's.
TLSR: What about regenerative medicine?
PC: Regenerative medicine is the most transformational of all the medical therapies, because it has the potential to reverse cellular aging. BioTime is working with stem cells that it can program to become cardiomyocytes, heart muscle cells. BioTime's researchers have seen the cells self-assemble in a dish and begin to beat like a heart! And we know from animal experiments that rejuvenated cardiomyocytes can integrate into the heart and heal damaged heart muscles. Stem cells are looking good.
TLSR: Does BioTime have a product based on this stem cell research?
PC: It has a subsidiary, ReCyte Therapeutics Inc., which is developing a delivery system for rejuvenated cardiomyocytes—sort of an epoxy that can be molded. It can make joints or flesh in reconstructive surgery. It creates a permanent matrix in which stem cells prosper, including in the heart. Third-party testing has validated this approach. But ReCyte Therapeutics' first product is slated to be endothelial precursors.
TSLR: What are endothelial precursors?
PC: Among gerontologists, there is a saying, "You're as old as your endothelium." The endothelium is a thin layer of cells inside the entire circulatory system—heart, arteries, capillaries. When you are young, it provides nitric oxide, which is an important neurotransmitter because it passes through cell walls. It is very short-lived, but it is responsible for vessel dilation. If you need additional blood flow for exercise or injury repair, or for any reason, the endothelium activates nitric oxide, which causes dilation and increases blood flow. When that does not work, there are all kinds of consequences—erectile dysfunction, hypertension, macular degeneration. It is a big killer, which is why the endothelium is the most important target for regenerative medicine.
TLSR: How can this process be industrialized?
PC: The endothelium does not regenerate by cell replication inside the cell walls. It exists as precursor cells inside the marrow of the larger bones, where the immune system resides. These cells simply circulate, find where they are needed, and engraft. If you were injected with your own endothelial precursor cells, they would migrate to the marrow of your large bones. We now know, from doing research on blood cancers, that the immune system can be rebooted without ablating bone marrow to generate replacement of old, sick endothelial precursors with new ones.
"How do you predict what irrationality will do? In the long run, productivity and profits will triumph."
Michael West, who founded Geron Corp. (GERN:NASDAQ) and now owns Geron's IP, did this with cows. And Geron and BioTime have merged on the stem cell/regenerative medicine front. Dr. West ablated the bone marrow of one group of cows and then injected epithelial precursors. But as a control, he also injected the precursors into cows without ablative bone marrow. In both groups, the younger, healthier endothelial precursors replaced the older, unhealthier ones.
Blood cancer researchers have found the same thing. This is really a remarkably simple process. It is now possible to take cells from the patient, convert them to induced pluripotent stem cells [able to become any kind of cell], engineer them to become endothelial precursors, and then simply inject them into the patient. The precursors migrate to the bone marrow and replace the older, nonfunctioning or less functional endothelium with what is essentially a child's endothelium in terms of health and functionality.
TLSR: That sounds transformational in more ways than one.
PC: I'll say.
TLSR: Let's talk about the financial fundamentals of both of these companies—BioTime and Inovio. Who are their competitors? How do they stack up against them?
PC: Frankly, Inovio does not really have competitors. It is up against companies with virus delivery DNA, for example—a technique for engineering a virus to infect a cell. The technique is not very efficient compared to Inovio's DNA-based vaccine techniques, and it has potential problems. There are companies using electroporation, which is the process of opening the pores and cell membranes to insert treatments into the cells. It is not clear to me, however, that these firms can legally do this because of Inovio's IP. Remember, David Weiner is one of the two largest investors in Inovio, and he is the father of DNA vaccine, so the company is positioned head-and-shoulders above any others.
"The macroeconomic drivers in life sciences are tied to the radical increase in life span that has taken place very recently."
BioTime is in the same IP situation, given the Geron merger. And its CEO, Michael West, has also acquired important IP from other companies. Nobody else is in any kind of a position to compete with BioTime in terms of regenerative medicine with pluripotent stem cells. There are lots of companies out there, but they are using adult stem cells for the most part. The potential of those cells is very limited compared to pluripotent stem cells.
TLSR: Are these companies accumulating debt?
PC: Both Inovio and BioTime are focusing, in the short term, on getting products to market. Both are engaged in clinical trials. It has been a long and expensive process to get there, but that is what it takes. Both firms are in the process of transitioning to companies with therapies on the market that produce income.
TLSR: How will the costs of healthcare decrease in your transformational model?
PC: Think about the cost of a heart attack and the subsequent care—hundreds of thousands of dollars over a lifetime right now. I predict that the cost of endothelial precursor therapy will eventually get that cost down to $10,000. Given the hundreds of thousands of dollars we spend on an Alzheimer's patient today, it's very unlikely that any of the drugs or the cells that are used to cure Alzheimer's will cost even a significant fraction of today's price tag.
TLSR: There will be less need for palliative care and radical surgery?
PC: That is right. Also, working careers will lengthen appreciably. People in the investment business know the impact of exponential growth on a portfolio. Despite the fact that everybody is worked up about income inequality, the real cause of income inequality is the fact that we have a much older and larger population. Older folks have worked long and grown their portfolios. As we extend life spans and careers, income inequality will increase spectacularly, as older people continue to get richer.
TLSR: What kind of life span do you look at for the average human of the future?
PC: A life span of centuries. Right now, our lives are bounded by our Hayflick limit—we are born with potential for about 120 cell replications. This is determined by the telomere, which is the nub on the zipper of an individual's DNA. Every time a cell replicates, we use up one of the telomere nubs. When we run out, the cell simply stops reproducing. Modern medicine is mostly trying to stop diseases that kill us before we reach our Hayflick limit. And we will do that. We will cure heart disease, cancer, Alzheimer's, liver disease; we will beat viruses; and we will end the factors that cause accelerated aging—inflammation, fibrosis, mitochondrial dysfunction. This will take us to a life span of about 120 years.
Beyond that, we will turn to regenerative medicine to rejuvenate cells, and there are a number of ways to do this. The first major breakthrough will probably be endothelial precursors rejuvenating endothelium, which will largely eliminate heart disease and stroke.
TLSR: Are we going to end up with 20 billion people who are 300 years old?
PC: That is a myth. If you look at the math, we are in serious depopulation right now. The West is disappearing. Iceland's birth rate is so low that the country has come to grips with the fact that it is disappearing as a culture. Japan is trying to increase its birth rates. Africa and the Middle East still have relatively high birth rates, but they are falling too. As they fall, we will see a diminishing global population. We are using a fraction of the earth's surface to produce food, minerals and energy. I am not at all worried about population.
TLSR: If you were able to live another 200 years, what would you do?
PC: I am interested in particle physics, and music and skateboarding.
TLSR: Thanks for your time today, Patrick.
PC: A pleasure.
Patrick Cox is the editor of Transformational Technology Alert. He has lived in the world of technology breakthroughs for the past 30 years. He has written more than 200 editorials for USA Today and has appeared in The Wall Street Journal and on CNN's "Crossfire" television program. In the late 1980s, he edited and published one of the first industry-insider software magazines, writing about topics like open-source and user-supported software long before those ideas were widely understood. Later, Cox wrote presentations and speeches for the CEO of Netscape. His consulting work has taken him to Fortune 500 boardrooms and inside the war rooms of national political candidates. His independent research is based solely on his investigations in transformational wealth-building companies and close consultation with Nobel Prize-winning economists and scientists.
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Anyone know why no one is trying to regenerate skin as an aged organ. Our product promotes growth factors. Be great to get regenerative product for skin surely you could get that to market relatively quick big market. Imagine resetting the biological clock of skin. Be plenty of wealthy clients that would pay. Understand that there are more pressing ailments to focus on.
Any thoughts?
Gnc is a franchise outside of America - they can stock what they want independently in the UK gnc are not aware or selling it
Also why are there no international suppliers yet for this product?
Doooooooh! Anyway good info sharing by all. UK customs are getting pretty thorough so it puts a lot of people off buying anatabloc I know close to 12 people that will not buy anatabloc because the duty is to steep. I wish the company would loosen up freight charges to international clients to encourage sales
Year4929 I live in the uk what u need to do is setup a account at www.shipito.com free postage in the US then you can ship to abroad all they charge is 8 dollars plus actual real freight charges. Also u fill in the customers sticker so u can says its worth 25 bucks this is how I get around duty works a treat the postage rates are brill most US company's completely destroy foreign customers with freight charges the tax man then cleans you up after I'm sold on this method been doing it for 3 years now
Is there a risk that the us and European regulators agree that stem cells are non patentable technologies? If so I assume this would kill all regenerative medicine pharmas instantly! Does anyone have a status of this? Assume big pharma would push for this as to restrict any transformative shift in the industry they have such a influential hold on the FDA. That recent article about isco disputing this in the European courts is alarming to say the least.