BioTime Makes History with Announcement of First Stem Cell Spinal Cord Therapy Results

John Mauldin


As my regular readers know, I am heavily focused on the massive monetary policy errors that are being foisted on the world by central bankers. This is not going to end well. My letter this weekend will probably be one of the most controversial that I have ever written, and I will probably lose a few longtime readers from the Federal Reserve. (Yes, some of them actually read me, probably more for the humor than the instruction, and for talking about me around the water cooler).
 
For this week’s Outside the Box, I was actually planning to send along a piece by someone else who noted the outrageousness of Stanley Fischer’s interview last week and whose thoughts on it were similar to mine.

I may send that piece to you later, but today something more important was brought to my attention, and I decided that we could all use a little great news. But this is not just a feel-good story; it’s something that I and my friend Patrick Cox have been talking about and predicting for years. We are in the midst of the most marvelous medical transformations in the history of the world. Take every medical advance we have seen in the last 250 years and add all of them together, and they do not equal what we will see in the next 20 years. In 2036 we are going to look back at our lives today and realize that we were still living in the Stone Age as far as medicine is concerned. I am fully serious when I say that, and I comprehend the radical nature of such a statement, but I believe it with every fiber of my being.

So, for today’s Outside the Box, I have for you Patrick Cox’s latest weekly letter, telling his subscribers about some fantastic results from one of the researchers he has followed for almost 20 years, Dr. Mike West of BioTime (BTX).

For the first time ever, neuroscientists have treated a total quadriplegic (a 21-year-old young man) with stem cells, and he has substantially recovered the functions of his upper body only two months into the process. The patient himself thinks there is reason to believe (or he is at least hopeful) that there will be further positive developments. What this means is that, using pluripotent stem cells, the scientists have been able to not only help this patient’s severed nerves repair themselves, but they have also demonstrated the potential to accomplish the same sort of regenerative healing in every organ in our bodies. This result was not due to the skills of the surgeons; it was due to the power of this stem cell process that has been around for quite a few years but is just now getting around to being used.  (This is where I could launch into a five-page rant on the FDA, but I will forbear.)

Yes, I know this sounds like science fiction, but it is not only the Federal Reserve that is turning the world upside down.

I remember the first time I met Dr. Mike West. Our one-hour meeting lasted almost nine hours as we realized that we were essentially brothers in so many ways. It was Patrick Cox who introduced us. For those of you who are not aware, Patrick is one of my longtime best friends and is the author of the Transformational Technology Alert newsletter from Mauldin Economics. He focuses primarily on biotechnology but looks at all sorts of interesting companies and technologies that are going to transform our world. He and I spend a lot of time on the phone and in person talking about the changes that are coming.

Patrick is an old-fashioned polymath. The depth of his understanding of multiple disciplines sometimes staggers me. He has major scientists calling him, sharing their results, and asking him questions, hoping that he will point them to other research they haven’t come across so that they can improve what they are doing. I kid you not. This guy is at the center of a nexus of anti-aging researchers and biotechnologists that has few parallels. I hang around him for two reasons: he is a fascinating guy, and we really do like each other and have so much in common; and (selfishly) he is the guy who is getting me access to the researchers and programs and studies that are going to allow me to live longer. I will admit to being a guinea pig on a few projects that are noticeably making a difference in my life and the way I feel. I cannot publicly talk about those projects (at least, not for a long time) for the obvious reasons. But I can tell you that you need to plan to live longer than you expected.

You are welcome to write Patrick and me off as just two more crazy, overly optimistic guys who think that somehow or other we are going to be able to push back the hands of time. I will readily admit that there is a correlation between the age of a person who looks at anti-aging techniques and the power of his belief in them. The older we get, the more we want to try to live a little longer and healthier. And maybe I am just one of those guys, but I don’t think so. I am just as skeptical as anyone else about most of the “anti-aging” techniques and drugs and pills that are foisted on the public but that are a total waste of time and money. But every now and then, there are some real nuggets of true biomedical gold, backed up by gold-plated research.

Patrick writes a free weekly letter called the Tech Digest that some of you get but all of you should. You can subscribe to it for free by clicking on this link. In his most recent issue, he talks about an anti-aging therapy being studied at the Buck Institute, the world’s leading anti-aging scientific research center based in Marin County, California (just north of San Francisco). I have written about the Buck Institute before and have been out to visit with them and met the heads of their teams. They are doing some truly remarkable work.

They are using a molecule called rapamycin that was discovered on Easter Island. It has been used to target cancer and some other things, but the researchers have found that it also seems to slow down the aging process. Scientists treated a mouse that was about the human equivalent of 60 years old, which allowed it to live to the human equivalent of 140 years. Now, this was with a version of the drug that you would not put into humans except under dire circumstances. But as Patrick and I were shown last year when we visited Buck, you can take an analog of rapamycin (called a rapalog in their terminology) and get the positive effects of rapamycin without the unpleasant negative effects. It just involves moving a few atoms here and there to create the new rapalog. The potential for some of these rapalogs to cure a wide range of other diseases is very interesting, and these drugs are going to be available to you in the not-too-distant (as in, les s than 10 years) future. I will be begging to be part of the clinical studies.

Coincidentally, Dr. Mike West and Patrick Cox will both be at my home Sunday afternoon and into the evening and then for some meetings the next morning. Patrick and I both feel that Mike West may be the single most important human being on Planet Earth, because he sees a clear path to true regenerative medicine that has staggering implications for lifespans and health spans. This is not your random visionary. Mike has the credentials and the research to back up the developments he is talking about. And he does not talk about them nearly as much in public as we would like him to. What he and his colleagues are doing in their labs all over the world is truly marvelous.

I really urge you to subscribe to Patrick's free letter to at least familiarize yourself with what is happening on the technology front. And for those of you looking to diversify your portfolios into transformational biotechnological and other cutting-edge companies, you should subscribe to Patrick’s primary newsletter, Transformational Technology Alert.

As I have said many times before, the world is in a race between the dire results of mismanagement by governments, which is destroying wealth, and the efforts of humanity to create wealth and well-being. There are going to be unbelievable fortunes made in the next 20 years from the plethora of new technologies and companies being created. As investors and fiduciaries, we have to try to make sure that we and our clients get as much of our wealth as possible to the other side of the debacle that governments and central banks are creating so that we can enjoy what I believe is going to be the greatest bull market in the history of mankind.

And with that, I will hit the send button, turn you over to Patrick, and let him tell us about one of the most remarkable developments of our time.

Your not planning to go gently into that good night analyst,


John Mauldin, Editor
Outside the Box



BioTime Makes History with Announcement of First Stem Cell Spinal Cord Therapy Results


By Patrick Cox

This is an early edition of my weekly alert. USC neuroscientists just announced truly historic news about  BioTime’s (BTX) (*see disclosure below) stem cell platform. For the first time, a quadriplegic patient with complete injury to the spinal cord has substantially recovered.

I’ve told you this was coming, but I wanted to get more information to you today as news of this long-awaited breakthrough in neurobiology spreads through the media. In fact, the news is even better than the information released by the Keck Medical Center of USC would indicate… and you should understand why.

A press release of this nature must follow strict conventions enforced by the SEC and FDA as well as traditional scientific guidelines. For example, the news release describes this spinal cord treatment, an injection of stem cells into the area of spinal cord injury, as “a procedure that may improve neurological function.” Watch the following video, however, and the only reasonable conclusion you can make is that the procedure has already done that.

Watch the entire B-roll video that USC has made available to the media. B-roll video isn’t edited as a story, of course. Rather, it’s meant to supply short video snippets for reporters. Nevertheless, most of this material is worth watching as it provides more information than is available in the extremely reserved press release, which is available here.


Note that Charles Liu, MD, PhD, says that this procedure should change the way that scientists and doctors think about spinal cord injury, making it possible to aim for full functional recovery for the first time.

The part of the B-roll that really gets me is seeing Kris Boesen, the 21-year-old man who received the treatment, wipe tears from his eyes while expressing his gratitude toward the scientists who made it possible. Prior to receiving BioTime’s stem cell therapy, Boesen was completely paralyzed from the neck down and couldn’t even lift his hands to his face.

Note also that Boesen mentions that his recovery is ongoing—from the top of the spine downward. We don’t yet know if he will regain use of his lower body, but he reports positive indications.

The critical part of this story that is entirely left out of the press release, however, is that the patient would have made a far better recovery if he had been treated promptly. Boesen was injured on March 6 but could only communicate his desire to participate in the clinical trial through head movements. He had to undergo assisted breathing therapy before he could give verbal consent.

That means that about a month of serious scarification took place before 10 million AST-OPC1 cells were injected into Boesen’s cervical spine. Scarring is the enemy of nerve reattachment and the reason that this procedure is only being administered to patients who have recently suffered spinal cord injuries.

Nevertheless, those stem cells managed to sort out and self-assemble, connecting severed nerves correctly from the upper and lower sides of the injury. This is the true power of regenerative medicine. It doesn’t rely on the surgeon’s skill. It’s the patient’s genome and the biological wisdom inherent in pluripotent stem cells that affect the cure.

None of the scientists will publicly say this, but I’m positive that the results would have been much better and more rapid if Boesen had been given the injection immediately following his injury. Additionally, Boesen started his treatment in the middle of a dose-escalating study, so he was only given half of the full therapeutic dose. (A full therapeutic dose will probably be 20 million neural stem cells.) So by no means should we view his dramatic and life-changing results as typical of what would happen to a patient given optimal dosage promptly after injury.
 
What This Means for Investors

Essentially, Boesen’s ability to lift light weight overhead after a catastrophic spinal cord injury is proof that Dr. Michael West, co-CEO of BioTime, was right when he launched this project at Geron, which he founded in 1990. I first met Mike, by the way, shortly thereafter.

West did not run the company he founded but acted as Chief Scientific Officer so he could concentrate on the science and technology. West made many of the most critical and ground-breaking discoveries regarding stem cells. Though at the time his theories and predictions were much maligned by the medical mainstream, his pioneering work has revealed the potential of stem cell medicine and made Boesen’s restored functionality possible.

West’s decision to hand Geron’s management over to others may have not been the best decision though. Despite extremely promising data regarding the spinal cord therapy as well as the cancer vaccine, the company seemed to lose its way. This actually worked to benefit current BioTime investors, however, as they are the majority owner of subsidiary Asterias (AST).

Moreover, Geron’s most important intellectual property was acquired for a fraction of the cost spent to develop its massive library of patents as well as several important technologies now in or near human trials. For example, Asterias also has a cancer vaccine headed for clinical trials in the UK. I consider it superior to those now being developed by cancer companies that have ten times the capitalization of parent company, BioTime.

Stock traders are just not that clever as a group, so the capitalization of Asterias has rivaled BioTime’s, creating interesting arbitrage opportunities. This doesn’t make sense, of course, but success in the Asterias spinal cord trial should help smart investors begin to understand that the same scientific biotechnologies implemented by Keck Medical Center of USC are also operative in other BioTime therapies.

BioTime subsidiary CellCure NeuroSciences is developing retinal pigmented epithelial (RPE) stem cells for the treatment of eye disease with the support of the Israeli government. CellCure has been given permission to start the second patient cohort in a human trial of RPEs for age-related macular degeneration, for which there is currently no cure. I believe that spinal cord injury is actually a more difficult target than blindness, so I’m extremely optimistic that CellCure’s therapies will work for various diseases of the eye.

The spinal cord results should also focus attention on my favorite BioTime subsidiary, ReCyte. It controls some of the company’s most revolutionary stem cell technologies. Among them is endothelial precursor stem cell therapy, which has been shown to rejuvenate the cardiovascular system in animals. ReCyte also has brown fat cell precursors, which have the potential to fix most of the world’s obesity problems, end most type-2 diabetes, and prevent or repair cholesterol-related disorders. 

This is a good day. I’ve been telling people about the potential of regenerative medicine for decades, but until today, we’ve had no proof that it works in humans.
 
It’s a good time to be alive and investing.
 

(*Disclosure: The editors or principals of Mauldin Economics have a position in this security. They have no plans to sell their position at this time. There is an ethics policy in place that specifies subscribers must receive advance notice should the editors or principals intend to sell.)

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