LS 101 - Regenerating Cells and Body Parts on Our Path to Eternal Life with Bioquark's Ira Pastor

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Welcome to the Longevity and Biohacking Show. This is your host, Fernando Aries, in partnership with the Hartman Media Company, filling in for Jason Hartman. It is my pleasure to welcome Ira Pastor to the show today. Ira is the Chief Executive Officer of Bioquark Incorporated. Bioquark is quite unique and a fascinating company. It develops substances called combinatorial biologics which reverse disease degeneration or the aging processes, as opposed to only affecting the symptoms of these conditions, which is what most commercial drugs do. Ira has 25 years of experience in the pharmaceutical industry and it has included drug development, commercialization, distribution. He has brought some drug candidates from the discovery stage all the way to phase three development. He's also the director of the Reanima project and he's going to talk to us all about it. Welcome Ira. It is a pleasure to have you in the show.

Thanks for having me, Fernando.

You are welcome. Usually I like to give the audience a sense of geography. Where are you located today?

I'm sitting here in beautiful downtown Philadelphia on the United States east coast.

Oh, excellent. Well, let's get right into it. Bioquark, the technology behind Bio Quark, is about reanimating and mimicking the biological regulation process. What is this? How does it work?

We as a company have had a long fascination. It's basically sort of this genesis of how this all started in really sort of going back to nature and looking at the vast range of organisms on this planet that from a human health and wellness perspective are much further advanced than we are as humans. Obviously your audience knows many lower organisms on this planet can replace lost or damaged organs and tissues that are identical in both Structure and function to the originals, Effortlessly regenerating a wide range of tissues, including spinal cords and limbs, heart, eyes, even major parts of their brains at the same time. What is less known is many of these same species have a remarkable capability for reversing cellular changes. Cancer is one of these things that, as an example, it's very rare in organisms that display efficient and active regenerative mechanisms. And many lower organisms you can give cancer to, but you can't kill them with cancer too easily because they're very good at taking tumors once they develop and just remodeling them and turning them into normal tissue. Some of these organisms can age and turn back time, Others can even die and be reborn. All of these abilities were basically connected with this underlying capability in organisms to in essence, turn back biologic time and tissues and start the development process over again. And it was this realization that sort of led to our interest in developing unique biologic candidates, as opposed to, say, cellular candidates that were capable of, let's say, awakening and remimicking these abilities in humans for the purposes of disease, health, and ultimately longevity.

Now, what's interesting is you mentioned that lower, you know, quote unquote, lower organisms can regenerate, but humans normally cannot do that. I mean, that's what you are tapping into. Why is that? Did we lose something along the way?

Well, you know, it's a fascinating from the sort of evolutionary biology side of things, there's extreme conservation across genomes, across nature. I mean, we are not much different than many of these so called lower organisms Possessing a lot of the same sort of gene sets. But what we did lose was sort of the regulatory control of these genes. And you find that, you go back and study amphibian regeneration, you find all these interesting genes that are activated, and you say, hey, let's just reactivate these in humans. But unfortunately in humans, doing that alone, you just wake up a bunch of interesting oncogenes. And so that is sort of not the direction we are planning on going from an evolutionary context. I think people will tell you that once we develop the, well, the ability as sort of warm blooded organisms to bleed substantially and ultimately die very rapidly from loss of that blood, Hence biasing us towards a very effective wound healing mechanism and scar tissue deposition. That was the point in evolutionary history where we sort of said goodbye to the, the need for any major types of rapid regeneration on the sort of the organ or whole body segment level. We're still pretty good at regenerating things like skin and blood, and obviously certain parts of our liver, but most everything else. We lay down scar tissue and get some structure, but with really no functionality.

How were you able to tap into this regeneration process in humans? In essence, how does bio quark attempt to do what it does?

We have basically taken a look at the last 80 years or so of regenerative biology research that's going on in this space. Specifically looked at the areas surrounding low organisms, primarily amphibian kingdom, and looked how these technologies have been applied in the area of human health care, primarily in the petri dish. And we're referring to a lot of the work that's going on not just with amphibians, but amphibian eggs, because just as a background eggs, oocytes are the only place in humans where we see the complete reprogramming dynamics occur. That is, that's the one place where age is turned back. And it's why our children are born age 0. It is the control mechanisms for all the morphogenic activity that goes on in creating a perfectly formed human being. Remodeling of organelles. And it's the reason why our children are born age 0 with none of the chronic diseases of older age. So we spend a lot of time looking at oocytes and specifically ooplasm, the cytoplasm of eggs, and understanding what are the biologic moieties that are responsible in this wonderful sort of biological regulatory kit that has been developed throughout nature for a billion years now. And understand what are those moieties and how they can ultimately be applied. Now this is a body of research that interestingly goes back, as I mentioned, about 90 years. People don't really know that we talk about things like cloning and we think of sheep, but the original cloning experiments were done back in the 1950s with frogs. Moving forward a couple decades, you got to the 1970s, where the work of folks like Professor John Gurdon, who just got the Nobel Prize a couple of years ago for this work, started studying what were known as egg free reconstitution experiments in the petri dish, where you could begin to study sort of the real time dynamics of ooplasm separated from eggs on the ability to reprogram somatic tissues. And this ultimately led to our interest where we will gladly tell you that we step on the shoulder of some giants to do this. But really taking the next logical step in understanding those biologic moieties, purifying them and seeing how they work together to create interesting, as you referenced, combinatorial biologics that could be then used again in humans. To initiate some of these reprogramming, remodeling, and regeneration events.

Just for clarity, you mentioned the material derived from eggs, essentially the all plasma, the yolk, has been looked at for age reversal, I guess, for decades. Is your technology using it, or is it concentrated on that aspect in order to accomplish what it needs to do? Or are you doing a combination of.

Things for this particular core program? Yes, we are looking at specific biologic moieties, micrornas, proteins, purifying them, understanding how they work in different combinations. Obviously, eggs contain a tremendous amount of material. Thousands of biological moieties, Various purposes have been identified in neoplasm over the years. We are getting a little more specific, drilling down and beginning to understand what specific components in neuroplasma Are responsible for these events and how we can sort of isolate them, purify them, and create interesting biologics to ultimately apply in humans. Because we, you know, obviously there's a lot going on there, and it really takes time to understand the intricacies of why nature in the first place Placed everything in the egg itself for these purposes.

Maybe at a deep enough level for understanding how would the regeneration happen in the body, Essentially, what are the signaling mechanisms that go on in order for the trigger of regeneration to start?

Well, typically it involves some type of damage. Now, that damage can be a injury event. It could also be just as it is in our bodies. Normally, it could be some type of state change in a tissue. So when a tumor starts to develop or oncogenic changes occur to certain cells, it's usually the cells nearby that get the signal to nudge that particular cell back in place. And that happens trillions of times during the day in our bodies, Just nice and quietly. And we don't usually think about it. It's going on right now, so we're having this conversation. So there is initially some type of signal. It can be a drastic signal, it can be slightly more benign. But ultimately, that type of sign triggers in a lower organism when, say, the amputation event occurs a variety of events, Triggers a reprogramming process in the tissue that remains in the damaged limb stump. It triggers a unique histolytic event to dissolve and destroy damaged extracellular matrix and dead tissues. There's even an interesting activation, and a lot of this has been published in the literature last couple of years, of the innate immune response to help benefit and enhance the regenerative mechanisms. Typically, a lot of these lower organisms don't possess an adaptive immune response and are more biased towards the needs. So there's a lot going on and it is really why we as a company and strategically we are taking a different approach to the sort of the single magic bullet concepts that big Pharma loves to play with. I can tell you confidently at the end of the day, there's not going to be a single magic bullet for something like this. And hence why we need to understand complicated combinatorial dynamics that go on in such tissues and mimic them in such a way.

It just amazes me that we all have trillions of cells that perform just the right function in the body at the right time. And we have this amazing system for fuel production, the mitochondria inside our cells, thousands of them in a single cell. From my understanding, it also creates signaling mechanism or signaling molecules that allow for cell repair and replacement. And we can certainly see this in a young age. Kids and babies certainly can regenerate and repair themselves very quickly. But as we get older, we notice that cuts and bruises take longer to heal. Is it the case that cells in an older person are not communicating as much as they should and you're somehow tapping into that process in order to reverse it?

Yeah, I mean, that's definitely a major component of what's going on here. We think the signaling networks separate from the actual damage event because we're trying to move away from sort of the reductionist thinking that if we can just find that one particular target, that we're going to have an effect. But thinking beyond that to yes, we have to have an effect at that target, but we have to think beyond the context of just the genes in that particular cell and the fact that that cell is a component of, as you just said, trillions of cells, or billions in that particular tissue, microenvironment. And that tissue acts in a certain way in a certain regulatory architecture, function over specific cells within it. And then even at the multi tissue level we have, which has become much more prevalent in recent years, although it was pushed aside in sort of the mid 20th century. But now many of the biophysical concepts of healing and repair, like biomechanical forces of biomechanics and mechanical transduction, like bioelectric fields at the tissue level, like biomagnetism at the DNA level, all of these concepts are coming back into vogue in our understanding of how there's much more going on than just at the minutiae. Because as wonderful as genes and proteins are, and are understanding them at a reduced level by themselves, they don't really do much. Genes are wonderful, proteins are wonderful, but they do not Give you higher form and function of the type that you're required for complex regeneration and repair. Other things are going on, like you mentioned, at the signaling level, genomic regulation, gene regulatory networks, tissue regulatory networks, and so forth. So, yes, long story short, yes, there's a lot going on at all of these levels that we really need to understand and control to affect the type of changes that we really think we need to see in disease reversal and regeneration.

So, you know, our show is about longevity and biohacking. So if we look at the longevity piece, you know, given the, I guess this rediscovery, you know, it's fascinating to me to see previous research being brought up to today's standards. And with the knowledge and the tools that we have, we can do so much more with them. In that context, can you make people live longer with your technology?

We like to say that a longer, healthier life will definitely be a side effect of what we're doing. Clearly, the implications for turning back biologic time in targeted tissues will ultimately trickle up to the broader organism in the context that we are working in, whether we are repairing a damaged kidney or spinal cord or part of the liver or what have you. In essence, yes, we are wiping out parts of regulatory state history and going back in time. So, ideally, yes, as a side effect of curing disease and regenerating, life, extension is very possible with these tools. Now, clearly, there are a few organisms on this planet that already utilize this capability. The immortal jellyfish, Turritopsis nutricula is one of the more popular ones that have been in the press a lot over the last couple years. You have this wonderful species that swims around in the ocean and grows up and, you know, later on in life decides just to start over again at a younger age. And it's very easy to do. Now, hydrozoans are simpler organisms than we are, but nonetheless, they are multicellular and have organs and multiple structures and so forth. But yes, ideally, we feel as a company, once again, in our strategy that the answer to things like aging are not, again, on the genomic output side of things. So not in the output targets of the genome, not as much the inflammation and the immune response, or typically the things that we think about that the pharma industry loves to target. But the control mechanisms behind those, really the underlying causes of why these shifts in regulatory state occur in the first place.

It makes perfect sense. By allowing you to live a longer, healthier life, you will live longer for you, taking care and doing the proper maintenance. Now, what is a typical scenario where bio quark is a good solution. Give us an example.

We like to say, with the exception of your infectious diseases, there are not too many killers of humans out there that we don't directly affect. When you think about the $7 trillion or so that they spent on health care each year, the majority of that money trickles down to really two things. Either diseases with an underlying cellular degeneration component, so your Alzheimer's, your Parkinson's, or your congestive heart failure, your type 1 diabetes, or diseases with an underlying cellular damage component, your cancer, fibrotic disorders, autoimmune disorders. Ultimately everything we do trickles down to this, because our goal, unlike sort of traditional pharmacotherapeutic thinking, where we want to target very highly specific endpoints of genomic output, is stepping back and looking not at that but at the regulatory architecture. So whether we can regenerate a component of a damaged spinal column or regenerate tissue in a kidney with glomerular nephritis, ultimately the mechanisms are all the same. That is reestablishing cellular regulatory state at a point prior to the damage eventually. So we think ultimately the bioquart platform is a much broader solution to regeneration and repair than other tools, Whether they be traditional sort of small molecule drugs or even in certain contexts, certain stem cell therapies. And really has a broad potential array of targets.

How would you compare it? Or how is it different from organ transplants?

Oh, well, you know, we get this. We have this discussion all the time. At the end of the day, we don't want you ever to have an organ transpl. A lot of the people will tell you, especially those that work on sort of the organ ex vivo organ engineering side. Most people do not require a new organ until a substantial part of the existing one is damaged. Our goal as a company is to prevent you from ever getting there in the first place. If we can repair your heart or your kidney or your liver, and the downward sequelae of events that typically takes place en route to an organ transplant, we win. You don't ever have to worry about dialysis again, as an example, or the kidney transplant in the case of the kidney disease. So we think organ transplantation is fine, but our ultimate goal is to see it eliminated. And we know there's a lot going on in terms of artificial organ creation and that's great, but we want to take care of everybody else that we don't want them ever have to get there.

So I guess the technology for organ transplants, maybe it's easier or Maybe it was accessible before. We get to the point where we are now in companies and people such as yourself, looking at this regeneration piece, and maybe there will be a shift. And I like the way you put it that you wanted to repair the organ before it gets bad enough that we would consider a transplant with all of its issues. We have an opportunity to make our own body fix itself and not bring a foreign object that could have all kinds of side effects that have nothing to do with what our body would produce to begin with. Now, let me ask you about. You're in the advisory board of Reanema, which is a company that explores neural reanimation. So I'll ask you probably the most interesting question that I can think of regarding Rhianema. How is it possible to bring people back from the dead?

Once again, you go into the non human world and you begin to realize that for decades research has gone on, primarily in the regenerative biology scene, that show that there are many organisms out there whose brains can be, for lack of a better description, blown apart, some which can be removed entirely, which grow back. This dynamic has been known to occur in nature at the same point. We sit here in the year 2016, yet we utilize the definition of death, brain death, around the world nowadays, which irreversible cessation of structure and function, or you know, the higher brain and the brain stem. But however, if you go once again into the literature, you find dozens of these gray zone cases of some form, primarily in.

Younger humans, of some type of reversal event. Now, the outcomes of those situations were never great, but they did show that somewhere between deep coma and brain death, what is known as irreversible coma, things are not always black and white. So the goal of the Reanima project, taking into account these two bodies of knowledge, that is regenerative biology and the gray zone that exists in the definitions of death, combined with the third component, and that is the area of living cadaver research, which is something that, although it doesn't sound sexy, it has gone on for several decades now in many countries. That is basically using the ideal model. The human being who has recently been declared dead, however, is on life support. And many pharmaceutical companies and other research institutions will undertake living cadaver research for things like toxicology and pharmacokinetic and pharmacodynamic studies, as well as studying novel medical devices and surgical techniques and basically bringing that to the table, saying, look, here is a wonderful model. Can we bring these three components together using the knowledge that exists in the year 2016? Not 1968 when they created the brain death definition at Harvard University, but using the technologies, the knowledge we have available today on how epomorphic regeneration of the brain occurs and utilize the tools that we have available today. Combinatory biologics, stem cells, tools for stimulating new neurogenesis in the persistent vegetative state in coma patient, bringing together once again a full understanding of all the dynamics in a combinatorial sense, looking away from the angle of the single magic bullet, because it's not going to exist, and ultimately begin to explore how we can stimulate neurogenesis and vascular genesis in the lower brainstem of these organs of these people, which is basically where our heart and our lungs are controlled and the primary drivers of life. At that point it is our Google moonshot. It is not happening tomorrow, but it is something that naturally connects to a lot of the things we are involved in and from just a central nervous system perspective. Because no research money goes into the so called severe disorders of consciousness nowadays, we feel that the trickle down learnings from regeneration of a higher nervous system are going to be invaluable to all CNS disorders, whether that's Alzheimer's, Parkinson's, ALS and what have you.

Are you currently doing any clinical research for recovering brain dead patients or what's the status on that?

The status on that is it's very early. We have created a protocol, we have created an informed consent because obviously research of this nature is different than when one recruits for a cancer or an Alzheimer's study. But we are getting out there and beginning to discuss with families, with other neuro intensivists, with religious thought leaders, with diplomats in certain cases, this very concept, because it obviously is something that its very nature extends beyond just biomedical research. And so we are taking baby steps, but it is something that we feel the pieces are there. I can't tell you that we're going to succeed in six months. But it is an area of biomedical discovery and endeavor that fits with the regenerative biology dynamic that we work with and is something that we feel needs to be done. Because as many people point out, we lose 150,000 people every day, 100,000 of those due to diseases of aging. But hey, there's 50,000 other people that die every day not due to aging, but due to severe damage to the higher nervous system. And we feel that research in that area is critical.

Yeah, well, bringing awareness is definitely a big piece of it and you're certainly doing your part. So if we unwind a bit, what specifically is your business model?

Well, from a U.S. perspective, we are traditional U.S. drug Development Company 101. We have spent a lot of time in the last few years in the laboratory doing our in vivo and in vitro models. We spend a lot time of time on CMC working on sort of the complex physiochemical characterization work that needs to happen before you send anything to FDA for ultimately clinical initiation in the United States. However, at the same time, we realize as a company that as important as the United States market is for us being a US centric company, of course there are 200 plus other countries out there that have different rules and regulations and everything that is a drug in the United States may not be considered a drug elsewhere or may have fast track capabilities in other countries, what have you. So we also have an organization that we're partnered with called Regenerage and we have started sort of spreading our tentacles a bit to other countries, partnering with groups and clinics external to the United States in seeing how we can move the clinical programs along faster in ex US territory. So we as a company are entirely focused on our US perspective. But realize that 2016 is a very different world out there in the pharmaceutical industry as we as sort of concentrated as it is nowadays. The United States is going to be representing a smaller and smaller piece of that over time and that we need to be truly a global country.

Beyond it comes back to the regulatory environment in the U.S. other countries can make faster progress and you need to pay attention to that. That is applied in any business, especially in the pharmaceutical area, where you can see developments. What's nice about it is you can stand on each other's shoulders, you can see other research being done elsewhere that can make your own program accelerate. And I think that's just a great aspect of human evolution. That's why going so much faster now, the collaboration is just at an exponential curve.

Yeah, I think while it may have been seen more as a niche in terms of this dynamic of development 10 years ago, now you have everybody getting involved. And I think the most interesting thing was just a few weeks ago, you know, Merck, one of the largest drug companies in the world, recently, you know, announced this medical tourism situation in China whereby, you know, on the mainland, you know, one of their main cancer drugs is approved for one indication. But China has set up a specific regulatory free zone for them, in essence on the island right off the coast where cancer patients can tap into Merck's drug for unapproved uses today. So I think there are a lot of these unique regulatory arbitrage situations popping up. We are, you know, we'll admit we don't know of many of them. We're just starting to get our feet wet. But we believe that 2016 and beyond, you really have to think internationally as well as US market.

Now, I imagine your research is very expensive. What about money to fund your research? Where is this coming from?

You know, to date we've raised about a million and a half dollars from U.S. east coast accredited high net worth individuals. You know, that's kept us moving along very nicely with the core research. But yes, to pull the trigger on a US registration program to get through sort of phase three on a fast track. Orphan indication has about a $25 million price tag on it and that is something we will be raising.

Excellent. And what are your biggest challenges? I can imagine. And we just talked about regulatory challenges, but there's also acceptance, as we mentioned about the brain dead topic and technical. This is a huge step forward in technology and in biology. What do you see now as your biggest challenges? Which area.

One of the biggest challenges that we face is the fact that we are undertaking a form of pharmacotherapeutic development that sort of flies in the direction of how things normally go in the industry today. We are not developing a discrete new chemical entity that does one thing. We are looking at sort of higher level combinatorial type products. And at the same time, as mentioned, we are also working with non human species. Now both of these things really form the basis for the drug industry over the last hundred years. Natural products in essence are the basis still to this day for 85 plus percent of every drug we take when we don't think about it. And at the same time, some of the most popular and prescribed drugs of all times aren't new chemical entities, but are unique combinatorial products that due to that very nature work in a broader sense. I mean, you think of a product like Pfizer's Premarin, which is really a nondescript mixture of estrogens derived from horse urine. But it's been on the market since the 1940s and it's never had a generic competitor. So you have these obviously unique development issues, but nonetheless we think history and this potential of how products have evolved and sort of the brick wall that we've been running into lately as a pharmaceutical industry and the difficulty in creating really new blockbusters, you know, majority of things that drug companies bring to market, they are not blockbusters and they're not new, they're redecorations of old stuff. Really requires new thinking and very similar into, you know, prior to what I was doing now, I was involved in the botanical drug segment, which was something new that the FDA created back in 2004, which is once again, how does one think outside the box and not develop the pure chemical entity, but think about the complex extract of a plant, for instance, and all the unique biologic moieties and biochemical modes of action that may be present in an extract or traditional medicine versus a pure chemical. So we think we're on the right path and we think some of this new thinking is around us and will be supporting this one.

Well, I agree 100%. It just feels like this is the future and bio quark is right smack in the center of it. I know we're running a little bit late, but I do want to have you Share any links URLs anywhere else where people can learn more about your company, your work, any technology advancements that you might want people to be aware of to again bring awareness to what you're doing.

Sure. So, and we definitely would love everyone to come visit our core website, bioquark B I O Q A R k dot com. You can also come read about the Reanima Moonshot Reanima R E A N I m a.com.

And lastly we have Regenerage, which is Regenerage Clinic and there's a link there as well. So if you can come visit and learn about all of these different models that we're pursuing, you'll find it's a rather fascinating story that goes beyond sort of Traditional Drug Development 101.

Well, I certainly second that is very fascinating. Well, thank again Aaron for coming to our show today and sharing this knowledge, this amazing direction that you're bringing us closer to you. Have a great day. Okay.

It's been a pleasure.

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