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October 3, 2016 Issue

CEOCFO MAGAZINE

 

Revolutionary New Technology for Counting Adult Tissue Stem Cells to be used in Transplant Therapies, Drug Development and Stem Cell Medicine

 

 

James L. Sherley, M.D., Ph.D.

Founder, Director and Chief Executive Officer

 

Asymmetrex

www.asymmetrex.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published - October 3, 2016

 

CEOCFO: Dr. Sherley, the tagline on your Asymmetrex website is technologies for stem cell medicine. What are you working on now?  

Dr. Sherley: Our lead product that we are working on now, that has actually completed development and we are now marketing, is a new technology for counting adult tissue stem cells. Well call it the AlphaSTEM Test.

 

CEOCFO: Why do we need to count them? Would give us a little context?

Dr. Sherley: If you think about the way we have done drug development and drug use since the beginning of medicine, we do it by knowing the amount of the agent that we are giving to the patient. We know the dose. If you think about any medications that you currently take, you take a certain number of milligrams and that dose information is giving you the information about how many of those drug molecules you are getting. If you look at clinical trials, they are based on the principal of dosing. We determine whether too much of a drug is toxic in the early phase of a drug development, and we determine whether or not a certain dose, number of molecules, is efficacious in later clinical trials. Currently, if you look at stem cell therapy, whether it be approved (approved could be for bone marrow transplant), whether it be blood stem cells, or other stem cells with effects that we are seeing in terms of the patients doing well after transplants. If you look at clinical trials where we are testing sources of stem cells for efficacy and maybe, even more importantly, if you look at all of the stem cell treatment clinics that are operating in the US and worldwide right now – and there is a recent estimate that that number may be greater than three hundred – in none of those cases do we know the number of stem cells that are being transplanted.

 

CEOCFO: What has been the challenge in counting and how have you figured out a way to do so?

Dr. Sherley: The challenge is really starting at the biology of the stem cells. If you are going to count something, you either have to be able to see it and recognize it as distinct from other types of cells or you need to work out biomarkers. Those are properties of the cells that you can measure that are distinctly specific to the cells. In the first case, it has been very challenging, because stem cells are such a small fraction of the total cells among which they are found. There are many cells in the body and tissues that look just like them. They are called committed progenitor cells.  So, if you go looking, morphologically, you cannot tell the stem cell from any other type of cell. Then the problem with biomarkers is that so far the biomarkers that have described are not specific for the stem cells. They also recognize other cells, which are more abundant. That means that these biomarkers obscure stem cells, when trying to use them to count stem cells. Therefore, those problems have not only plagued transplantation of stem cells, but they have also plagued the basic research; and stem cell research has the same problem of basically operating in a blind spot. You can tell by the function of the cells that they are present. So that is, if you have an individual who is lacking blood stem cells and you transfer stem cells from another donor, you can clearly improve the health of the recipient. However, if you ask how many cells are transferred, it is unknown. That means you have two problems. Sometimes not enough stem cells are transferred. One of the most important cases of this is in the case of childhood leukemia, where we often use cord blood as a source of blood stem cells; and cord blood has fewer stem cells and often not enough stem cells to rescue the child from the cancer therapy. Therefore, the rate of failure is estimated to be between fifteen to twenty or so percent of the time that a child gets a transplant and does not have enough stem cells. The other problem is that in some cases you do not have enough transplant samples for all the people who need them. Therefore, in some cases, people are getting transplants for bone marrow, but there are more stem cells than are needed for that patient. If we could count them, then we could give that patient what they need and then provide other patients with the residual.

 

CEOCFO: What is the science?

Dr. Sherley: There are two things that we brought together that allow us to do this. The first one is basic science understanding of how stem cells grow in culture. We are fortunate, because it turns out that what stem cells do in our bodies, they continue to do it when they are put into cell cultures. That feature is unique for tissue stem cells. We refer to it as asymmetric self-renewal. It is that to produce other cells in tissues, a stem cell does not change its character while producing cells, which change in character. For instance, in the hair follicle, there are stem cells there. They are dividing, then maintain their number at the same time they are producing cells, which are going to form that hair shaft continuously. Therefore, that is an asymmetric self-renewal that allows the tissue to reproduce itself over and over again. That property is unique to stem cells.  So, if you can measure that property or if you can identify that property, then you can count stem cells. There are two ways of going about doing that. One is to have a biomarker that is specific for that property. We have some of those in development. We think two of them may be specific enough to allow it to us to count stem cells directly. However, the method we are currently using is a mathematical method. It turns out that this asymmetric self-renewal can be defined simply in mathematical terms. What does that mean? It means this: If you take any human tissue and put it in a culture dish, because stem cells are the only cells which essentially divide indefinitely and they produce cells that stop dividing to make hair, skin and the heart ,for example, in culture, when you count the total number of cells as a function of time, that growth that you see, that total of cells that you count, they are ultimately dependent on the asymmetrical self-renewal of stem cells. Therefore, we partnered with a very smart company called AlphaSTAR Corporation, which in fact is an aerospace engineering company. However, the importance for this discussion is that they have some amazing computer programmers there. Therefore, we worked with their computer programmers and developed a method where we can simply take a tissue and grow it in culture, measure the total cell number and then we use the computer to simulate the data. That simulation has in it the number of stem cells whether they are alive or dead, or whether they are dividing. Therefore, we can take the data, fit it with our simulations, and then estimate the number of stem cells in any human culture.

 

CEOCFO: Are you rolling out your AlphaSTEM Test service this fall?

Dr. Sherley: Actually, we had our first direct marketing to interested parties yesterday morning!

 

CEOCFO: How will the service work and who should be thinking about it?

Dr. Sherley: That is a great question. Who should be thinking about it? It turns out that quite a large number of practitioners in both clinical medicine and also research and also drug development. For examples, we are very interested in pharmaceutical companies that are developing common drugs; drugs for diabetes, drugs for heart disease. The reason is the following. One of the problems why we do not give drugs to patients is because they failed because they are unsafe. One of the worst kinds of unsafe is causing chronic organ failure. If you are doing drug evaluations, if you have drugs with chronic organ failure, they are not going to make it to patients. They are too toxic. Now, identifying such compounds is complicated. You have to wait until you are in expensive animal studies or you have to wait until you are actually testing volunteers. One of the main reasons that drugs cause chronic organ failure is because they are toxic to stem cells. If you kill the stem cells in a tissue you will get chronic organ failure. Therefore, we can use our AlphaSTEM Test to identity those drug candidates that are going to fail later, much earlier in stem cell culture and so cost a great deal less money. Therefore, we are offering to pharmaceutical companies the opportunity for the early discovery of really toxic drugs.  So, they are a target for us. Other obvious targets are cord blood banks. It is estimated that around the globe they have got about seven hundred thousand samples stored; and the stem cell number is not known for any of them. We can provide a new quality control check for stem cell potency, when they are going to be used to treat, for example, leukemia in children. For those five hundred or so stem cell clinics around the country that are providing stem cell treatments, without knowing the stem cell number or stem cell function and quality, it can be really beneficial there for the patients. These clinics can also do better work at understanding how the number of stem cells relates to their outcomes. There are about four or five hundred clinical trials currently taking place that are looking at different types of stem cells. They are basically like a stem cell clinic, except they are being performed with the features of science allowing us to better interpret results, in terms of controls and treated and untreated subjects. However, even in approved clinical trials that are happening now with stem cells, in fact, it is difficult to compare the outcomes from one patient to another; and from one trial to another; and one arm of a trial to another without knowing stem cell dose. Therefore, we think we can really add a lot of value by providing AlphaSTEM testing for unapproved treatments and approved clinical trials.

 

CEOCFO: Are the companies or the people that should know or should be interested in what you are doing aware? Is there acceptance that it can be done mathematically?

Dr. Sherley: We have been in this for about three years. The company got started back in October of 2013. In our first year we really worked around developing the product. We have been doing this for some time with AlphaSTAR Corporation, before I founded the company. Therefore, in the past two years we have actually gotten some experience with responses to what we have done. I have yet to have anyone challenge me or even ask the question about whether or not our math works, which I am actually surprised by. I think there are two reasons for that. One, the underlying value of my expertise is I have done twenty plus years of research elucidating tissue stem cell kinetics, and AlphaSTAR Corporation is known in the aircraft and aerospace industries for its computational systems to figure out real important problems. For instance, with the Columbia Space Shuttle, they were one of the companies involved in receiving the award for using computational approaches to figure out what went wrong. The problem is, I think more than anything else, is that you are dealing with a field, stem cell transplantation medicine and stem cell research, which has gotten used to not being able to count cells for fifty years. Again, like in the case of pharmaceutical companies, they cannot determine whether stem cells are toxic. Therefore, they are using animals; and they are using people. What we are in the process of doing is getting people to understand the value we have in getting rid of those workarounds. If you have got a pharmaceutical company, if you have got something that you have been using and you have been getting some drugs through, it is a challenge to say, “Let us stop doing that, let us start doing something differently.” Therefore, we have to show that we have confidence that when they start using the AlphaSTEM Test, they are not going to lose any good drug candidates, that our assay is not going to tell them something is not going to work when it will pass. We have to build experience. That is what we are working on; really building experience in both academia and industry, to make some of these demonstrations. For instance in the case of cord blood transplants, we are trying to find clinical partners that already have in their freezers transplant samples that worked successfully for saving children and that were unsuccessful. We want to assay those to show that we have the power to predict what was going to happen. We are in that phase right now where working with new customers is very important for the health of the company, but also from continuing to show how applicable our method is. That is really the big challenge. It is innovation; and innovation is always tough when trying to introduce into existing systems.

 

CEOCFO: Are you funded for your next steps?

Dr. Sherley: Right now, we have not yet gone out and done this little road show, like looking for funding. The company has been applying for research grants. We have some grant applications pending right now.  However, it has been largely funded through private investment and development funding from AlphaSTAR Corporation. Therefore, where we are right now in terms of our business going forward, we think we now have the cache of information for seeking venture funding and our goal is this year or next year. The other possibility, if we are able in fact to have a good marketing campaign and generate revenues from our early adopting customers, we think that would provide us with more development funds and make us more attractive for venture funding.

 

CEOCFO: Why is Asymmetrex Company so important?  How is it a game changer?

Dr. Sherley: We feel it is because stem cell medicine had been held up by two main problems. One is the simple act of counting tissue stem cells. The other, which we have not discussed, which represents the second part of our activity is producing them, manufacturing them; making stem cells as pure defined populations. We have focused on those two problems. We are solving one. We think we can solve the other one, and when we do, we think it is going to change the face of stem cell medicine in the world, and that is what our mission is.


 

 

“Currently, if you look at stem cell therapy,… in none of those cases do we know the number of stem cells that are being transplanted.”- James L. Sherley, M.D., Ph.D.


 

Asymmetrex

www.asymmetrex.com

 

Contact:

James L. Sherley, M.D., Ph.D.

617-990-6819

jsherley@asymmetrex.com



Asymmetrex

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