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Advice Pool - Could a Pig's Sexual Maturity Hold a Key to Reversing Diabetes?
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. By substituting the Sertoli cells from adult pigs, ins
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
tead of those from baby pigs, Dr. White may have made a significant 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 Uni
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 Uni
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
versity 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 es
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 es
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sentially 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
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
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
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
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 a
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
t 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
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
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
: 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 fiel
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d 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 dia
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
betic 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
StockInterview: We are assuming Sernova Corp’s patented insulin-producing cellular replacement therapy, called Sertolin, is how the company plans to commercialize
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
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’r
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’r
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e 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 di
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
scovered 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 h
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ave 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
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
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 mode
StockInterview: Upon which model are you basing your research? What are the strengths and deficiencies in this mode
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
l?
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
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
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
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
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
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
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 producibl
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
e 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.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
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
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
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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