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In this StemCellPatents.com interview, our special guest interviewer, Thomas Ichim, CEO of Medistem, speaks with Alan Lewis, CEO of Novocell, regarding the company's advances towards curing diabetes. This interview examines many aspects of Novocell which include: the history of Novocell and how the company was formed; their strategy for being a leading-edge researcher in using stem cells for curing diabetes; and their encapsulation technology.
Here's the interview transcription.
Tom: Hi my name is Thomas Ichim I'm the CEO of Medistem . I've been asked by StemCellPatents.com to do an interview with Dr Alan Lewis the CEO of Novocell. So I guess we can begin by talking about the history of Novocell and how the company got to where it is today.
Alan: Thanks Tom, well Novocell is an interesting company its 1999 vintage and it was founded in Irvine California. It combined with 2 smaller companies which were embryonic stem cell companies, Cythera from San Diego and Bresagen from Athens, Georgia. So the three companies combined forces with one mission in mind. To create cell therapy for diabetes, using Novocell's encapsulation delivery technologies and using the ES cells of the two other companies
Tom: Now if I remember correctly Cythera was one of the original ones to come up with embryonic stem cells to make President Bush's list, is that correct?
Alan: That's correct and in fact Bresagen was also an early player in creation of stem cell lines and we had NIH funding for a number of the lines generated by Bresagen, obviously that was prior to President Bush's announcement for support for this whole area
Tom: I see, now how did the companies come together and who initiated this?
Alan: It's a classic situation where boards of directors knew each other and realized that Novocell had a need for unlimited source of cells and there was recognition on part of the smaller stem cell companies that they had a need for a more therapeutic focus and a more clinical as well as manufacturing experience. So putting the three companies together made a lot of sense. Obviously it allowed the company to have a stronger story. We are not dealing with 5 or 6 people in two different sites and another company in Irvine. So what we've been able to do over the last couple of years we moved the company to San Diego. So the old Cythera is now the headquarters, although its under the name of Novocell of course.
Tom: So one of the things that is very exciting is that it seems you have a very focused company, it seems like your focus is strictly making insulin producing cells. Would that be correct to say?
Alan: Absolutely, in this business it's dangerous to have too many irons in the fire. We recognize it's tough. Its like climbing a mountain, its easier to climb one mountain than many mountains, so we very much focused on diabetes, which we believe is one of the premier opportunities for human embryonic stem cell derived products.
Tom: My background is adult stem cells, and as an outsider looking in on the area of embryonic stem cells, it seems like your company is on the edge in terms of making these insulin producing cells. As an outsider I see everyone saying in the literature that they made insulin producing cells. I get a feeling you are more advanced than others. Is this correct?
Alan: Well I think part of it is the focus, some of the other companies that have made those claims have other programs in their portfolio. I think by having a singular focus with a very talented group of scientists thinking about the issues at hand makes a difference. The realization when the three companies were merged was that Novocell that had the encapsulation technology was doing proof of principle studies using cadaveric islets, showing that the encapsulation technology which obviously worked in smaller species would work in the clinic. This being proof of principle. Then as quickly as we could we will bring along the ES generated islets or insulin producing cells and then use the same encapsulation material to protect the cells from the autoimmune system of the type 1 diabetics or type 2 diabetics.
Tom: So Novocell is actually in the clinic, I mean clinical trials, with the cadaveric islets right now from what I understand.
Alan: Yes we have initiated a clinical study approximately 2 years ago, patients were treated with these encapsulated cadaveric cells
Tom: Sorry is this inside the liver you are administering them?
Alan: No the difference between us and the Edmonton Protocol was we didn't use the liver, we used the subcutaneous sites, the belly region and the back region, the second point was that we did not use chronic immune suppression. These patients were off all immune suppression. There was a little bit at the beginning of the study just in case the encapsulation was leaky which could attract immune cells and cause a problem. The islets lasted for about a year. Firstly we demonstrated safety, there was no problems vis a vis giving the islets subcutaneously, no sign of inflammation, no sign of fibrosis, no circulating changes in any of the antibodies that you may anticipated. We also demonstrated efficacy.
Tom: You pointed out before, one of the main advantages of what you are doing with your ES programs is that you are recapitulating the normal course of pancreatic development. Now do you have IP filed on the different stages of the recapitulation.
Alan: As you are well aware Tom, IP is one of the 3 or 4 major cornerstones for our industry and we wouldn't get any investors if we weren't filing IP or getting issued IP. So yeah we have been filing aggressively over the last few years to ensure the pathway from embryonic stem cells to insulin producing cells is mapped and we will have freedom to operate in that area.
Tom: Now the beauty, from my understanding, of your IP strategy is that some of these claims when they issue, will not only protect your technologies for stimulating the differentiation process but will also prevent others from using any technology to drive cells down this path of differentiation to the definitive endoderm and to the islet.
Alan: Certainly. As of today we don't have issued patents but we have many filed patents and we have been in constant contact with the USPTO.
Tom: Exactly. As long as you have the claims submitted if anything, even if they don't get issued, you have a scorched earth approach so others cant get the claims issued
Alan: Certainly we are not doing it to block others from working in the field. Its more important that we can work in this area and have the freedom to operate and a freedom to carry on and perform what we need to do so that we can make a product that will help the patient.
Tom: And see that touches upon something that attracts me, this encapsulation. I mean, Type 1 Diabetes in some ways is cured by the Edmonton Protocol.
Alan: Yes, it can be. The Edmonton Protocol is where you get pancreatic islet cells from cadavers and you implant them into the liver of these patients, type 1 diabetics and but unfortunately you need to put them on chronic immune suppression.
Tom: And you don't have enough donors
Alan: It takes a couple of pancreases to treat a single patient. What we are proposing is to generate an unlimited supply.
