Renowned Cambridge University researcher and Sernova Corp (OTCQB:SEOVF) advisory board member Dr. David White may be developing a new technique for broadly reversing diabetes in humans.
By co-transplanting Sertoli cells together with insulin-producing cells into diabetic rats, his recent research demonstrated that insulin-producing cells can survive (without the mandatory use of anti-rejection drugs), and can protect the rats against diabetes.
The big breakthrough in Dr. White’s research was his substituting the Sertoli cells from adult pigs, instead of co-transplanting the Sertoli cells from baby pigs, as other researchers had grown accustomed to using in such transplants.
StockInterview: How long have you been involved in researching the reversal of diabetes?
Dr. David White: I first started my interest in treating diabetes by transplantation of insulin cells when I was on faculty at the University of Cambridge in the United Kingdom. That would have been about 1996. I guess I’ve been doing this now for over 10 years.
StockInterview: Please tell us about xenotransplantation and why this could play an important role in reversing diabetes.
Dr. David White: The issue with using xenotransplantation is essentially one of numbers. There has been some excellent work done in Edmonton (Canada) that shows that human-to-human transplants of insulin-producing cells can reverse diabetes. The problem is that you need human donors to produce the insulin producing cells, and they’re in short supply. (The) Edmonton (Protocol) is treating perhaps twenty patients each year.
If you look at the numbers, there are about 80,000 diabetics per million of population. Of those, perhaps ten percent are called type I diabetics who would most benefit from our therapy – 8,000 per million of population. If you look at the availability of human donors in Canada, you’re talking 15 per million. So, what happens to the other 7,985 patients? If you do xenotransplantation, animal-to-human transplants, we use pigs. There is no shortage of pigs. We can have thousands and thousands of them. That’s the big benefit of our technology. It’s a therapy instead of just pushing at the edges.
StockInterview: On February 5th, Sernova Corp announced the results of your recent diabetes research. The headline stated ‘Insulin-Producing Cells Could Survive and Function without Anti-Rejection Drugs.’ Why is that an important milestone in helping to find a way to reverse diabetes?
Dr. David White: The important thing about Sernova’s technology is that we use a very specific cell called the Sertoli cell. What this Sertoli cell does is: it confers immune privilege. Now the big breakthrough that we made was to discover that if you use Sertoli cells from adult pigs as opposed to what everybody else in the field has been doing – using it from sexually immature baby pigs, we get very much greater protection. In fact, we can completely suppress the immune response to pig insulin-producing cells with these adult Sertoli cells. What we’ve been able to do, is to co-transplant Sertoli cells and insulin-producing cells into diabetic rats, show these insulin-producing cells will survive, and will protect the rats against diabetes. We think that’s a pretty exciting step forward.
StockInterview: We are assuming Sernova Corp’s patented insulin-producing cellular replacement therapy, called Sertolin, is how the company plans to commercialize your ongoing research to help reverse diabetes. How quickly are you moving toward this goal? And what steps must you take before it could become commercially available?
Dr. David White: I think it’s important that people realize how both the pharmaceutical industry and the biotech industry work. First of all, we’re regulated by the FDA. To some extent, it’s the FDA that will determine both the steps we must take and the timelines. Let me give you a simple example. Many years ago, I was involved in the development of the drug called Cyclosporin-A which is used to prevent transplants rejecting. The big breakthrough that we discovered was in 1977. That drug came on the market in 1984, a seven year time span. Now we made our basic big discovery on Sernova’s technology in 2005, so (we are) three years in. On that basis, we probably got another four years to go on commercialization.
Hopefully we can cut that time down, because we already have a significant amount of clinical data. We will certainly be asked by the FDA to go into Phase II trial. But they may ask for a trial lasting one year, they may ask for a trial lasting two years. That extent, the timeline is out of our hands. Clearly, we are pushing ahead as fast as possible. Our next step is to gather all the data needed by the FDA to apply for an IND (Investigational New Drug). That is permission to start a clinical trial in regulated countries. That would be the United States and Canada.
StockInterview: Upon which model are you basing your research? What are the strengths and deficiencies in this model?
Dr. David White: There are no good experimental, pre-clinical models of diabetes. The best model is the human diabetic. The model we currently use, is to transplant pig cells into diabetic rats, but we make the rats diabetic by poisoning the insulin-producing cells they would otherwise have. Then, when they’re rendered diabetic, we cure them with the Sertolin product. It’s not a great model, but it’s the best model we have.
StockInterview: Your company has assembled quite a prestigious Scientific Advisory Board. How did your peer group react to the results of your recent research? What advice did they offer?
Dr. David White: We do have an excellent Scientific Advisory Board made up of some of the best experts in North America in the field. We presented our data to them a couple of weeks ago, and they got very excited. The basic advice they offered was to say: Do more pre-clinical studies, beef up your numbers, show how producible your technology is, and deal with the technological issues like defining the purity of the product, the best ways to prepare it, how to scale up for commercialization. All in all, it was a very exciting meeting. We’re very encouraged by their enthusiasm and their acknowledgement of the progress that we’ve made.
StockInterview: What else should investors know about Sernova Corp and the research you are currently doing?
Dr. David White: I think the important message is that our goal is to get to clinical trial as rapidly as possible and our target is to be discussing those possibilities with the FDA by the end of this year.