By co-transplanting Sertoli cells together with insulin-producing cells
into diabetic rats, his recent research demonstrated that
insulin-producing cells can survive and can protect the rats against diabetes. By
substituting the Sertoli cells from adult pigs, instead of those from
baby pigs, Dr. White may have made a medical research breakthrough.
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.
COPYRIGHT © 2007 by StockInterview, Inc. ALL RIGHTS RESERVED.
James Finch contributes to StockInterview.com and other publications.
His focus on the uranium mining and nuclear fuel sector resulted in the
widely popular “Investing in the Great Uranium Bull Market,” which
is now available on http://www.stockinterview.com and on
http://www.amazon.com
