As my readers may know, I have followed SmartCells, Inc. since its inception in 2003, and have followed the key milestones because I believe the company's Smart Insulin concept is light years ahead of anything now in development from the insulin cartel dominated by Novo Nordisk, Eli Lilly and Company, and Sanofi Aventis. Essentially, the company's form of insulin, if it continues on its thus-far successful path, will release insulin molecules in direct proportion to a patient’s blood glucose levels, eliminating the nasty side-effect of hypo or hyperglycemia caused by all current forms of insulin. The NIH/NIDDK is perhaps one of the company’s biggest "investors". The biggest benefit, however, is that Smart Insulin would eliminate hypoglycemia, and significantly reduce the need for frequent testing. As you might imagine, the concept is great, but it could kill most forms of insulin now on the market, command a huge premium in price, and would effectively kill a big piece of the home diagnostics business, so some pharmaceutical and healthcare companies would like to see the product die. SmartCells has secured venture capital and funding from the National Institutes of Health, but skeptics remain.
Much of the skepticism is perpetuated by the insulin cartel, in part, because their drug pipelines for improved insulin are pretty barren -- even Novo has relatively little in insulin development beyond its current portfolio of "modern insulins" (a euphemism for insulin analogs), except another version of Levemir that supposedly does not encourage weight gain which is aimed mainly at the type 2 market. Lilly has nothing in its pipeline other than inhalable insulin, and Sanofi Aventis faces continued criticism from investors over the lack of disclosure on drugs in development. We do know, however, that insulin and diabetes care is a very tiny piece of the company's total business.
As I reported following my conversation with SmartCells CEO, Todd Zion, the outlook for Smart Insulin appears quite positive. It appears there is more good news: on Tuesday, September 18, 2007, Biomedical engineers at The University of Texas School of Health Information Sciences at Houston announced pre-clinical test results in the September issue of the International Journal of Nanomedicine demonstrating the feasibility of a smart particle insulin release system that detects spikes in glucose or blood sugar levels and releases insulin to counteract them.
The study, "Glucose-sensing pulmonary delivery of human insulin to the systemic circulation of rats," was conducted in the laboratory of Ananth V. Annapragada, Ph.D., an associate professor at the UT School of Health Information Sciences. Research assistant Efstathios Karathanasis was lead author and postdoctoral fellow Rohan C. Bhavane was a contributor on the article. The full press release can be seen here.
Some more details on the underlying mechanism were also revealed. I couldn't tell whether it was the exact same mechanism used in the Smart Insulin concept (you can check out their U.S. patent application, "Stimuli-responsive systems for controlled drug delivery" here for details), but the validity of the concept has been proven, which surely solidifies SmartCells concept now being developed.
The University of Texas researchers tested a smart particle system consisting of a blood sugar sensing protein named concanavalin A (Con A) and bundles of tiny fat bubbles called liposomes that are loaded with insulin. "Con A binds insulin-containing liposomes that are coated with sugars, to each other, to form the inhaled particles," Annapragada said. "When blood sugar becomes present, the Con A releases the particles to bind independently to the sugars. The released particles then release their insulin."
One caveat: this study was conducted on rats with diabetes. As we are well aware, rodent models are poor replicas of more complex mammals, but what has been examined is proof of concept, not human clinical trials. Those will need to follow, but this indeed validates the idea now under development at SmartCells, Inc.
Thursday, September 20, 2007
Smart Insulin Nanostructures Pass Feasibility Test, Study Reports
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7 comments:
The concept behind this SmartInsulin sounds great.........Imagine, no more Hypo's or Hyper's.
What bothers me is the route of delivery-Pulmonary.
Scott,
Thanks so much for reporting on this!
While most rodent studies are irrelevant for humans, this one should be. It doesn't depend on the way that the rat pancreas functions or how rat enzymes or proteases behave. It's looking at how the nanostructure behaves in a blood environment, and how insulin releases into the blood stream. Rat blood is very like human blood I'd imagine.
What a joy it would be to have an insulin that only activated when bgs were over the threshold.
I think the larger concern with this kind of technology has to be what those nanostructures do when they hit the liver, kidneys, capillaries, etcs all over the body over an extended period of time. That would be an issue that would require a LOT of testing.
The concept is much more in line with how a normally functioning endocrine system actually works versus our present treatment model which requires us to test frequently and each of us develop our own individually scaled model of anticipatory insulin dosing.
Which works, but has its obvious drawbacks as we all know.
Even if Smart Cell's insulin were more expensive..... I wonder if it still could be less expensive for people, like me, who use about 15 test strips a day? LOVELY, life w/o hypos. That just seems so foreign that it is incomprehensible!
You are right, Barry, re: the pulmonary delivery method, but I think this does suggest that there are several means of accomplishing the same thing with Smart Insulin, so that has to be good ... for patients, that is!
I agree, Jenny, that there is certainly room for concern, its still very preliminary, but the fact that companies are pursuing this concept is a good sign. As for whether it will get sufficient testing, we can only hope that it will get more than insulin analogs got, but given the most recent Congressional move re: the FDA, that seems unlikely, which I think is criminal. We need to do away with these user fees funding 90% of the FDA's budget!!
Finally, to the Completely Inconsequential Flux Capacitor and Chrissie in Belgium, I hope this will eliminate hypos ... many people with type 1 especially suffer from them due in part to damaged counterregulatory function due to the autoimmune attack on the Islets of Langerhans, yet in practice, it seems to be "blamed" on patient error rather than on flaws in treatment. I hate hypos more than anything else associated with this condition, so I'd like to think this might eliminate this as a challenge, but we do need adequate testing. Lets hope we get that, too!
It's exciting.
Scott
Thank you for the detailed update on SmartCells. I'll have to put them on my watch list for future developments.
Like others, I wouldn't mind paying a premium for a safer treatment. While it reduces highs and lows I wonder whether that would be sufficient to reduce other complications. Also, what might be the implications of taking this new compound long-term. I guess we'll have to wait and see.
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