Yes, I spoke with the CEO of Smart Insulin tonight for a good 20 min. They will be starting human trials likely in a few months unless the FDA delays it. The drug is apparently working really well in the large animal model and Dr Zion sounded optimistic it will do the same for us. RIght now they are mainly waiting for FDA go ahead. I’ve had faith in this therapy from the beginning as it seems to be such a practical solution to keep us regulated in the normal range like the non-diabetic. I think if everything passes inspection so to speak we could see this available within four to five years. Its a shame its still that far away but I believe this is a very realistic future therapy for all of us. That aside Dr Zion happens to be such a humble down to earth person and truly cares for all of us.
I am crying! I have been waiting for this. Yes, wish it was alot sooner, but I am so excited! Thanks for the update.
Appreciate the update. Been crossing my fingers since I heard about Smart Insulin. I’d sign up for a trial.
Next you speak with Dr. Zion please tell him we’re counting him!
Interesting how five years always seem to be the time frame. Hoping, hoping.
Guys,
Dr Zion was kind of explaining all the regulatory stuff they have to abide by with the FDA which is likely why it could still be that far off. Once the trials start they should know basically right away how the drug performs in humans at least short term and which if the same as in the animal trials this should be a winner! Unfortunately even if it works like they anticipate for us they can’t just get it to the market shortly after. Trust me Dr Zion wants this breakthrough as much as we do but they must follow FDA protocol which he stated is kind of a PITA and very time consuming hence the projected timeframe from where they are now. Either way the few lucky patients in the first trials could very well be in normal glucose range 24/7 in the next few months. Gotta be excited bout that!
How exciting! 
Thanks, Gary.
FDA approval sure can be a PITA process. We’ll all have to do a major letter writing campaign if they drag their feet. I imagine there’s going to be serious opposition from the pharm companies. They stand to lose a lot of $.
Can someone explain for the scientifically challenged especially, what Smart Insulin is?
Smart Insulin will respond to BG levels. Theoretically, you’d take one injection a day & insulin would be released as needed. No more highs & lows, stable BG. How incredible this would be! It would be best thing next to a cure. Forget the artificial pancreas & mechanical devices.
For the nitty gritty on how this delivery system works, Google. It’s amazing, brilliant, genius!
The only organizations that may prefer this to fail would be whoever is in the testing supply business. Big Pharma has nothing to loose as they will cash in the same as they are doing now. If the drug works at the level it is intended the search for a cure might lesson as at that point It wouldn’t be like living with same disease we have to deal with now.
Wow! Unbelievable! I can’t even imagine how that is possible! Little nanobots running around inside us? But then most technology seems like magic to me, so I’ll just have to take it on faith!
I interviewed Todd Zion in 2006 or so (see my interview here for more), and he does indeed seem confident, which is necessary for the CEO of a company. They have also had little difficulty in getting angel investors, as well as funding from the NIH/NIDDK and most recently, from JDRF. However, Novo Nordisk is likely to sue the company, even if patent infringement is warrantless (see my post here for details on that, largely to delay SmartCells as much as possible, since Novo’s business is likely to be destroyed by this product, so delaying it as long as possible would seem to be the best Novo could do to delay the product as much as possible). Also, while phase 1 trials is a great sign of progress, it still then has to proceed to Phase 2 and Phase 3 trials, so it will be longer than 5 years at the earliest before this could realistically be commercialized knowing the FDA (that’s best case scenario, not the most realistic), as this would not simply be a modified version of an already approved version of insulin, so they will need to do all phases of clinical trials (unlike some of the others that are now under review by the FDA). Nevertheless, I think this is a promising development and its a great sign that this product seems to be progressing along very nicely and has thus far not encountered any unanticipated delays!!
Scott,
Someone else I was in brief contact with actually went to the smartcells lab and spoke to Dr Zion directly. She said he claimed the drug at best case scenario could be availible by 2014. I doubt it will happen that fast but its not completely out of the question.
I am going to think positive…and I have alot of hope. Keeps me going and I just have to keep believing.
How do you get into his clinical trials? What is the age cutoff? Will he take teenagers?
Jan,
I did not discuss with Dr Z. when recruiting will start as he/they are still in the wait themselves. Most trials usually don’t start on time so my guess is this probably won’t be starting more towards the later part of the year. I can’t imagine any age group other then maybe real young would be excluded. I would guess as soon as they need patients it will be posted either on their website or maybe through the JDRFs. If nothing on the trials is mentioned in the next few months I will try to get back in touch with Dr Z to get any update he may have.
Did you ever check out living cell technologies. They are using pig cells encapsulated in an alge. Rejection meds are not needed. They are in clinicl trial stage II in new Zealand. They have tried this on humans for 10 years. it always works it is just a matter of how long they last and how well they regulate the sugar. You really should go to thier web cite. It gives hope that something will be along in the next 10 years.
Any new word on this?
Diana,
I am very aware of LCT. As promising as it sounds I think the cost factor will be an issue there. I see the Smart Insulin therapy as something that could reach everyone once it proves itself. I just don’t see encapsulated pig transplants being the solution for the masses of people with diabetes. I believe that many will benefit from that treatment eventually but not everyone. I also wouldn’t count Dr Faustman out either. Temporary disease reversal would be nice… and maybe cheap too.
I haven’t contacted Dr Zion since our last conversation. I probably got a little overhyped on my own when I suggested human trials starting in a few months as Dr Zion never confirmed that. He said to have hoped to be starting in the next few months however I think they should be getting real close. My guess is at earliest towards the end of the year which at this point is only a few months away. I may try to get hold of him in the next couple of weeks to see if he can give me an update.
I just looked up smart insulin. I would love to use it…