Want a New Cardiovascular System?

Want a New Cardiovascular System?

Seven weeks ago, on January 3, the father of stem cell medicine made an announcement that will be remembered forever by historians. Dr. Michael West, CEO of BioTime Inc., launched a subsidiary, ReCyte Therapeutics, to commercialize endothelial stem cell therapies to reverse senescence in the cardiovascular and immune systems – the number one killer in the developed world. This newly launched enterprise will have a profound impact on our government and economy as well as our own expectations regarding investment, retirement and lifespans.

West’s announcement elicited the same response that other similarly historic medical breakthroughs have in the past. For the most part, it has been ignored.

Though I first met West over 15 years ago and have followed his progress as he developed the tools needed to take on cardiovascular disease, I’m nevertheless stunned to see the revolutionary stem cell therapy actually approaching the clinic. Despite having studied and written about the fact that such leaps in science are almost never recognized when they appear, I’m nevertheless disappointed. West, after all, is not some fringe scientist. He founded Geron and only recently published proof in a peer-reviewed journal that he can reset the telomere clock of aging in stem cells created from normal adult cells. And all of this is done without the use of embryos or cloning.

If you think I’m exaggerating about this media fail, do a Google News search on the keywords “BioTime”, “ReCyte”, “heart”, and “disease”. As I write this, the search produces nothing but the company’s own press release. But read just the title and think about it. “BioTime Subsidiary ReCyte Therapeutics, Inc. to Develop Therapies for Age-Related Cardiovascular and Blood Disorders”. http://www.b2i.us/profiles/investor/ResLibraryView.asp?ResLibraryID=42754&GoTopage=1&Category=1802&BzID=1152

Admittedly, this is understated prose, but the statement clearly says that ReCyte’s purpose is not to cure diseases caused by lifestyle, genetic defects, or pathogens. Though it will also do that, ReCyte is forthrightly announcing that it will cure conditions caused by normal human aging. This is truly revolutionary.

How BioTime Will Give You a New Heart and Vascular System Nonsurgically

This is how it will probably happen. A clinician will draw and send some of your blood to BioTime’s subsidiary, ReCyte Therapeutics. ReCyte will introduce four transcription factors into some of your blood cells. Those four transcription factors (OCT4, SOX2, LIN28, and NANOG) activate the programming machinery of your DNA that determines what cells are and do. The result is the creation of your own induced pluripotent stem (iPS) cells. These cells have full telomere lengths restored, having effectively turned back the clock of cellular aging to age zero.

I’m not going to get into the science of telomeres here today, but I can give you a link, recommended by my seventeen-year-old son, at the University of Utah’s genetics website: http://learn.genetics.utah.edu/content/begin/traits/telomeres/ . For advanced students, you can read a description of West’s process with telomere restoration in an article published in the journal Regenerative Medicine. http://www.futuremedicine.com/doi/abs/10.2217/rme.10.21

West, by the way, applied for patents on this process as far back as 1999. His application for IP covering the use of those four transcription factors to create iPS cells was filed in 2005, before Dr. Shinya Yamanaka published his “mouse paper” describing the process and years before his human paper.

These new “pluripotent” stem cells, made from your own cells, are identical to embryonic stem cells in that they do not age and can be potentiated to become any cell type in your body. They can also be multiplied and stored indefinitely. Only when these cells have started down the path to their final cell state does the biological clock begin ticking.

You can probably start this part of your rejuvenation process within months, as it does not require regulatory approval. ReCyte has announced that it will begin banking individuals’ cells this year in preparation for regulatory approval.

ReCyte will then take your rejuvenated pluripotent stem cells and shepherd their conversion into the adult stem cells that repair hearts and vascular systems. These are endothelial precursor stem cells. This “potentiation” is routine for BioTime now, and the ability was developed as part of the company’s ongoing mapping of natural stem cell development or differentiation.

When ReCyte has enough of these cardiovascular repair cells (and regulatory approval in some legal jurisdiction), they will be given back to you via transfusion. There will be no immune reaction, because they are your own cells. We know what they will do because you have lots of these cells already, though they are as old as you are. The new cells, though, will be only weeks or months old biologically and will displace the older and less effective endothelial precursor cells.

Once in your body, your new rejuvenated stem cells will produce the various cells needed to replace old and damaged heart and vascular cells. These new cells will be vigorous, fully functioning, and youthful. In time, you will have, essentially, a new heart and vascular system – without surgery. The same technology can and will be used, incidentally, to rejuvenate your immune system.

Everything I’ve just told you is public information. For the vast majority of you, however, I understand that this is the first time you’ve heard about it. Once again, I have to wonder where the media is. I could understand skepticism from people who have not spent time studying stem cell science, but there’s not even skeptical coverage.

Incidentally, my concern is not simply academic. The impact of this breakthrough therapy and others that will come in its wake will be enormous, and we should be preparing for them now.

I’ll deal with some of the reasons we need to prepare for the reality of BioTime’s therapy in a bit. First, though, let me address the understandable skepticism that many of you are experiencing. Ultimately, some of you will have to see medical data from rejuvenated patients. That’s fine. It’s coming.

You should understand, however, that BioTime’s stem cell therapy is completely unlike the typical small-molecule drug candidate and company. These cells are inside you now. They are not some new manmade product with unknown side effects and dosing concerns. Only the process of manufacturing the rejuvenated endothelial stem cells is new. The actual mechanism of action, the replacement of aged cardiovascular cells with new cells, is taking place in your body even as you read this article. If it didn’t work, you would already be dead.

BioTime is exploiting natural biological processes, but they will use rejuvenated versions of your own cells. Every aspect of this science has already been demonstrated and observed in nature. No human has yet received this therapy, but every link in BioTime’s chain of logic has been studied and validated.

The company still needs to develop scalable procedures and get regulatory approval somewhere, but I consider that all but inevitable. Even if the FDA drags its feet, BioTime has numerous options internationally. The company already has subsidiaries and facilities in Israel, Singapore and, through Hong Kong, China. The Israeli subsidiary, Cell Cure Neuroscience, recently penned the first agreement between a stem cell company and big pharma, Teva Pharmaceutical Industries.

I foresee no problem finding a jurisdiction eager for the profit and prestige this technology will generate. Not only would there be tax revenues, the associated income from health tourism would be substantial. Let’s do some simple back-of-the-napkin projections to get a handle on the type of revenues we might expect.

First, compare BioTime to Dendreon Corp., which is projected to earn $1 billion annually on a prostate cancer vaccine that costs north of $90,000. Dendreon’s improvements in lifespans, however, are measured in months. Cardiovascular rejuvenation could easily extend patients’ lives by a decade or more.

Let’s say that BioTime charges $100,000 per patient. I actually don’t think the cost will be that high, but we are just thinking out loud. There are easily 10,000 people in the world annually who would pay that price for the cardiovascular system they were born with. I expect that the actual number is far more than 100,000, but we’ll stick to 10,000 for this thought experiment.

At $100,000 per therapy, these 10,000 patients would generate $1 billion in revenue annually. That’s less than 40 transfusions per working day in one year. One clinic could easily handle that volume.

The Impact of Nonsurgical Cardiovascular Rejuvenation

Until now, four out of ten of us were destined to die from age-related cardiovascular disease. If you’re one of them, your healthy life span will be extended significantly by endothelial precursor therapy. You will be spared the extraordinary expenses associated with dying of cardiovascular disease, as will our health-care system. According to the American Heart Association and the National Heart, Lung, and Blood Institute (NHLBI), the cost of cardiovascular diseases and stroke in the United States in 2009, including both direct and indirect costs, was an estimated $475 billion.
Initially, BioTime’s therapy will be expensive, but not as expensive as the cost of treating an end-stage heart condition. In time, most of the procedure will be roboticized. Costs will plummet. BioTime’s technology, I believe, could reduce that $475 billion cost by as much as 90 percent. We’d feel that. The same basic technology, as I’ve said, can also be used to reboot immune systems, giving you youthful, vigorous resistance to disease, no matter how old you are chronologically.

Normally, of course, analysts like me don’t “name names” outside of our subscription firewall. In my line of work, our marketing departments “tease” a story, without giving away the name of the company, to get new subscribers. John Mauldin, however, believes that the BioTime story is too important to keep secret. In my experience, John usually gets his way and, to prove it, he’s putting online the presentation that I gave at a private Agora Financial conference in July.

In that presentation, I talked at some length about BioTime and a number of other important companies and technologies that will transform our world. Dr. West, in fact, spoke at the same conference. I predicted BioTime’s ReCyte announcement in that presentation, though I have to admit it has come earlier than I expected. I also laid out a bit of the history of public and media rejection of past medical breakthroughs.

My marketing department has slipped in a sales pitch, but I’m not going to apologize for being part of the capitalist system. I’m proud to help attract investor attention to the companies that have the potential to save our collective glutes from the fecklessness and irresponsibility of our governing class. More on that in a bit.

I’m grateful, therefore, to John for this opportunity to speak to people outside of my subscriber base. Much of my career has been spent in the not-for-profit arena of think tanks, and I remain deeply concerned about public policy issues.

My biggest concern is one that you, as a reader of John Mauldin’s Outside the Box, know well. It is the enormous debt burden that threatens to turn the United States into Greece or Portugal. The current deficit and debt are not what keep me awake at night, however. It is the impact of demographic changes on entitlement obligations and taxation.

Only months ago, the first Baby Boomer became eligible for Medicare. As I explained in another article here, titled “The Ultimate Hedge in Economic Crisis,” health-care costs rise exponentially as we age. We know, in fact, that current levels of health-care spending will not suffice for a rapidly aging population.

Costs can be kept down artificially through rationing, but the American public has demonstrated its growing rejection of any kind of triage – “death panels,” in the popular parlance. There are ways to reduce spending somewhat, such as true tort and insurance reform, but they would not provide enough in savings to fund the additional demands of an increasingly older population.

Simultaneously, the birth rate has plummeted. Social Security and Medicare were crafted when far fewer lived beyond retirement age. Additionally, birthrates were high enough to insure that there were far more young people in the tax-paying workforce than older people reliant on transfer payments. None of those conditions exist today. The demographic pyramid is flipping and will, in keeping with the metaphor, fail.

This is not, by the way, a situation unique to the United States. John has given you an excellent overview of this worldwide problem in a recent column titled “Global Aging and the Crisis of the 2020s.” It can be summarized briefly, however, as this: Fewer working young simply will not be able to pay the medical bills of a growing world population of older retired people.

Those tempted to interpret this as an ideological position are sorely mistaken. It’s just math. If enough resources to cover the medical costs of the coming “gray tsunami” were to be taken from the productive sector, it would devastate job-creating investment and innovation. The economy would shrivel even further, guaranteeing that our current distress would be viewed nostalgically.

There is a simple solution, however: People work longer or invest more wisely to fund more of their own medical needs. Problem solved.

Though you can find little support for extending the retirement age, either in the current administration or public opinion polls, it is increasingly accepted as an inevitability by those thinking seriously about the problem. This is despite the well-known gift of my cohort, the Baby Boomers, for self-absorption and a sense of entitlement.

I’m actually very optimistic. Healthy lifespans, or health spans, have risen continuously for the last hundred years, but that increase is about to accelerate with quantum improvements in medical science. The BioTime therapy is only one of many truly remarkable advances that are coming at us now.

Moreover, there seems to be, for the first time, serious public recognition that the current system is untenable. Older people may be willing to argue now that they deserve the massive transfer payments that come with current retirement ages. That claim will become laughably absurd, however, as healthy lifespans begin to increase dramatically.

BioTime’s endothelial stem cell therapy is only one of the quantum movers, by the way. Besides other stem cell therapies, new cancer technologies are in development that will soon put cancer into the same historical dust bin as polio and smallpox. I hope to tell you about them in a future article here. There is even real reason for hope regarding Alzheimer’s disease.

John and I both recently learned, incidentally, about a revolutionary drug technology that could become universally adopted within a few years. This remarkable but amazingly inexpensive therapy could easily extend average healthy lifespans by five to ten years – and quickly.

Given these rapid advances in health spans, the pressures to extend working careers will be irresistible. Significantly longer and healthier lives will increase the urgency for making this change, but it will also make the sale far easier to close.

These coming technologies will not only increase income-earning career lengths and the resources that go into the health-care system, they will also reduce or postpone medical costs associated with the last stages of life. The postponing of end-stage medical costs, accompanied by increases in total economic wealth, amounts to a cost reduction. This is because increased costs are irrelevant if they represent a smaller percentage of personal and total wealth, which is the natural outcome of longer working careers and reduced transfer payments.

You know that John was warning about the housing bubble while Washington was denying it existed. Many of us were issuing that warning, with a visible lack of results. Hopefully, we have learned enough from the current fiasco that we just might avoid the next one. The way to do so is to help accelerate the technologies that will allow us to outlive the iatrogenic economic disease inflicted on us by our intellectual elites. We must, however, begin planning for it now.

Incidentally, I have no personal financial interest in BioTime or any of the companies I discuss in the accompanying video. That is not to say that I do not have an interest in seeing these transformational medical technologies come to market as soon as possible. We all do.

Patrick Cox