This podcast episode interviews Paul Latta. Paul has been on the forefront of diabetes research for over 27 years. As a business person, Paul has helped scientists with their research on finding a cure for type 1 diabetes. Currently, Paul is working with scientists in Miami, Florida on an advanced islet cell encapsulation technique.
If you are interested in type 1 diabetes or insulin dependent type 2 diabetes cures, you will want to listen to or read this interview.
Paul Latta Searching For A Cure
DWB: Welcome everyone. Today, we are excited to have Paul Latta onto our program.
Paul has been working for over 25 years in cutting edge medical research companies to find a cure for Type 1 Diabetes. Paul’s focus has been to search for ways to protect islet cells, which are insulin producing cells, by encapsulating them. This type of treatment would allow people with Type 1 Diabetes to no longer rely on insulin injections, which would effectively cure Type 1 Diabetes.
The process can get fairly involving. So let’s welcome Paul to this show, so that he can explain his work in further detail.
Paul, thank you for taking the time to speak with us today. We are pleased to have you in our program.
GUEST: Thanks, Erich. I appreciate the invitation. I am happy to talk to your listeners.
DWB: Okay. First off Paul, could you please tell us a little bit about yourself and how you came to work in the diabetes medical research field?
GUEST: Sure. Well, it’s a kind of a long evolving story. But the short version of it is that I was not in this field at all for the early part of my business career, until my daughter was diagnosed as a Type 1 Diabetic at age nine. That was some 27 years ago.
So I merely started researching the field. Fortunately, I was in St. Louis; my hometown at the time. I went down to Washington University in St. Louis and found out that one of the top islet research programs in the world under Dr. Paul Lacy and Dr. David Scharp at Wash U was working on effecting a cure for the disease. So I got involved with those two doctors, and volunteered my time to help them with business kinds of issues, because they didn’t like to do those things, and that was my background in business. So I got involved, and I got a little more involved as time went on.
I really thought I could contribute to their work by helping them with business issues. So I sold my business interests in St. Louis, and went to work as a volunteer in the labs of Dr. Lacy and Dr. Scharp at Wash U. I spent about 10 years there, and actually went in to the labs and learned to do a number of the procedures, because I was ready to learn how to do medical research, and scientific research in the lab. So I wanted to learn to be able to talk about that intelligently, so I went into the lab there. I learned to do some of the islet work in Dr. Scharp’s lab with the dogs and primates in ending up doing cell transplantation. This was in 1986 and 87, actually, when I started there.
So I spent a number of years there learning the trade, if you will, working on business issues. Then when Dr. Lacy retired, and Dr. Scharp went to California to a biotech company. I came down to Miami, Florida where Dr. Camillo Ricordi, who I had coincidentally known in St. Louis, when he was a Post Doc Fellow and had just been recruited to head up a diabetes research institute at the University of Miami. So I came down to Miami, and worked with Camillo, kind of doing the same things I was doing in St. Louis; helping in business and working in the labs here in Miami, for another five or six years, until an opportunity came up to go out to California and set up a biotechnology company start-up called Novocell in Irvine, California; and this would be 1999.
So, and this is in partnership with Dr. David Scharp from St. Louis, who was the chief scientific officer of Novocell. So we started Novocell, and the focus was on the encapsulation, a new form of encapsulation that David and I believed was the best that encapsulation could be done. So we worked on that for about five years. At the end of five years, we had chronicled up to the level to start a clinical trial with our technology. But then, some things happened with the different investors and corporate partner and that program, kind of, was semi shelved for the time.
So then, I came back to Miami in 2006. In partnership with Dr. Camillo Ricordi, we started another company here in Miami called Converge Biotech; working with new technologies that Camillo and I have been working on separately. So now we have two or three technologies which I could explain in some detail if you like to know, that we are converging, hence, the name of the company, because we find over the years that there is no one single technology that we think is going to be a cure for this disease. It’s going to take multiple technologies to solve the multiple problems about Type 1 Diabetes.
So, in the five or six years that I’ve been here now, there have been several new technologies developed to where, we believe, we are ready to file for what’s called an IND for FDA Approval to start one of these technologies in patients, even at the end of this year, or early next year. We’ll follow along with early technologies so that the end product and all of these that have to do with clinical trials is, I’m sure, you don’t understand, will take seven more years. If we’re successful to through clinical trials at the end of the day, we’ll have a final new therapy for Type 1 and insulin requiring types of diabetics too, I should say.
DWB: If I could, if I could just interrupt…
DWB: If I could just interrupt you there, Paul, I apologize. Just so I’m clear, is the primary technology that you’re trying to develop, something called encapsulation?
GUEST: Yes, that’s… That is the primary tech. Go ahead.
DWB: Could you explain to people what encapsulation is number one? Number two, why is it so difficult to do?
GUEST: Sure, okay. So, as I mentioned in the beginning, we know that you can implant insulin producing cells called islets back in to a diabetic patient. They will, in fact, work perfectly and correct the disease, actually, for many years, in a number of patients who had been transplanted.
The problem with that is there, it’s two-fold. One is these islets are all transplanted into the liver of the recipient right now which is a dangerous site to put cells. Secondly, the patient has to be on full immuno-suppressant of their immune system; that is taking drugs to suppress their immune system so that the transplanted cells would not rejected by the recipient’s body.
These immuno-suppressive drugs are very strong and powerful. They deplete the whole immune system down to the point where the patient is now susceptible to viruses, cancers, bacterial infections, and so on. So that is not a good trade off for patients, broadly speaking. That has been the main hold up for advancing islet cell transplantation into millions of patients who could actually benefit from it.
So in order to stop and avoid these dangerous immuno-suppressive drugs, we’ve been working to encapsulate the islet cells in a chemical barrier that acts as a filter so that the things that the islets need to live, like oxygen and nutrients, will come to the pores of the encapsulation barrier. But the bad things that would destroy them, like immune system cells and antibodies in the recipient patient, are not going to penetrate the filter. So that now, the islet cells can come in and work perfectly long term in the patient without a need for long term drug immuno-suppressant that are so dangerous to the patient. That’s been our goal.
The second part of your question; why is it so difficult? It’s because the perfect kind of encapsulation system is very difficult to achieve. You need a chemical barrier that’s not toxic to the cells or the patient. It has to be, more or less, invisible so that the immune system doesn’t react to the barrier itself. It has to be uniform so that the capsule around each of the cells is uniform, and the pores that you want need to be uniform; not too big and not too small. It has to be long lasting and non toxic, as I said, to the patient.
So accomplishing all of those things in this kind of perfect chemical barrier, it’s been a challenge to all of us working on encapsulation for the last, you know, even longer than I’ve been in it for 30 or more years. But we’ve learned a lot. We know what works and what doesn’t. The kind of encapsulation system we are working on at our company Converge, we call Conformal Coating, which you can think of as like a shrink wrap that goes around each and every individual islet in sort of a minimum volume, kind of, a membrane that goes around the cells so the good things can diffuse in and out, and yet it keeps the immune cells and antibodies from killing the cell.
So we’re now working with this new system in our learned models of diabetes, and with some success, I could say. When we build up that data a little more, we will move up to some primates and some diabetic primate models to show that it works in a higher level mammal. Then if that data is successful, we would apply to begin a trial in humans, you know, with this encapsulation technology.
DWB: Okay. Paul, did you say earlier in the interview that, you thought that you might be able to move to human studies within the next year or two, or did I mishear you?
GUEST: Yes, you heard correctly, but as I said, there are several technologies, encapsulation being the primary one. You’re correct in that, Erich, but there are other technologies we are developing as well, and one of these is what we expect to be able to move into the clinic in the next year. When you move out of the liver, which is the site that’s being used now, and you move to another safer, easier site, which is our goal, you kind of encounter the problems where you need to enhance the site so that it’s more receptive for the islets that you’re going to transplant there. So, one of the other technologies’ we are developing is actually that; enhancing the site.
The site we’re focused on is just what we call an omental pouch. If can visualize a patient, there is a kind of a lining that goes around the stomach area that’s called the omentum. You can make a little incision on the side and pull out some of the omentum, and we can put our islets right in there, wrap that back up in a patient in a very simple outpatient procedure that’s, you know, very minimally invasive to the patient. That’s the site we’re focused on.
The trouble is you need to enhance that site. So there are other technologies that involve putting the islets in a scaffold that gives them a three dimensional home so they’re not just clumped together, so this three dimensional scaffold will do that. Also, from the scaffold, we can release certain drugs that enhance the site by down regulating the immune system temporarily and up regulating factors that will increase the blood flow and promote blood vessels growth in there, which is what these islets will need.
So the technology that we believe will be ready for the clinics sooner, because we’ve been working on it longer, is exactly this scaffold technology. We’re now at the primate level, with that technology and we expect to file with the FDA later this year, to begin a trial with that single technology as early, as 2014. So that’s the first phase of what we will go in to clinical trials with.
Then following that, the Conformal Coating technology which we’ve been working on less time is about a year behind the scaffold technology, we would expect to file late in 2014, to be able to start that trial in 2015 with that technology.
So to be clear, the end goal is to marry those two technologies together at the end of the day, but you have to do the clinical trials to prove that both are safe and effective for patients.
DWB: Well it certainly seems that it is easier said than done. [Audio skips track 00:14:00] So wish you good in the research.
GUEST: Well, it’s true it’s been a long process. You know, when I started this, I thought we’d have the cure in ten years, but I’ve learned how difficult human biology is, and in particular, the human immune system, which is what we’re dealing with here in the Type 1 auto immune disease. So one has to, maybe, hopefully, leave the immune system intact so that it protects the patient from other problems, you know, cancers and viruses, as I said, and yet not continue to destroy the transplanted cells that need to be there to restore the normal glucose levels in these patients. Also, cells are there, and they keep their blood supply, and they’re happy, and they’re not destroyed. They do exactly that. They do completely control the blood glucose levels as normal in the patient without the need for any insulin injections at all.
So that’s our long term goal, which is to be able to do that for all the patients without the need for continuous long term immuno-suppression.
DWB: I want to thank you again for taking the time to speak with us. It’s always interesting to hear about cutting edge research from people who are actually in the trenches trying to get it done. My understanding of that, if someone had a strong interested in Type 1 diabetes wanted to contact you, they can do that through our e-mail address at info[at]diabeteswellbeing.com, is that correct?
GUEST: That’s fine. I would be… Yes, I would be happy to respond to specific questions from, you know again, particularly seriously interested people, and in particular, Type 1, or as I say, insulin producing, insulin requiring Type 2 patients. I’d be happy to, you know, to be able to respond as best as I can in any of those inquiries.
So thank you, Erich, again for the giving me the opportunity to talk to some of you listeners, you know. I hope this gives some people some information about, and some hope, that there are always a lot of people out here working on an effective cure for this disease.
DWB: Thank you very much, Paul.
GUEST: Good day. Bye now, Erich.