Diabecell update

So, since I’m sitting here at work waiting for someone to hand me papers to run down to Brooklyn Supreme Court (which might sound impressive, but as you Law and Order watchers know, Supreme Court is the lowest court of general jurisdiction in New York) and don’t want to start any substantive work, since it’ll just get interrupted, I figured I’d check on Diabecell.

So, the good news: Their trial is going well. As of 2/11, 5 patients received the lowest dose (5,000 islet equivalents /kg body weight, (“IEQs/kg”) 2x separated by six months) and 2 got 10,000 IEQs/kg. Of the 5 patients who received the lowest dose, one hasn’t had enough follow-up time to get complete results, but his A1c dropped from 9.8%–>7.2%, with a 6% reduction in insulin requirements. The other four had reduced requirements from 10-38%, and a mean drop in A1c from 8%–>6.8%.

In the higher test cohort, one patient showed no improvement and dropped out of the study. Diabecell improved their quality control, and the next patient showed, after 4 weeks, a reduction in A1C from 8.3%–>4.8%, and reduction in insulin requirements of 60%.

They plan to do 3 more patients at 10,000 IEQs/kg and then 5 at 15,000 IEQs/kg.

The best part is that there have been no major episodes of hypoglycemia.

See http://www.lctglobal.com/downloads/cms_latest_news/2009-03-03-2009-02-10-LCT%20Announcement%20Feb%2009%20ClinUpdate%20Final_110209.pdf for more details.

Now, that’s the good news.

The bad news is that they have decided that, at least for the time being, the US market is not a priority. "LCT has been in discussions with advisors in Russia to outline a commercialisation route and business plan. To focus on this commercialisation plan, Dr Robert Caspari stepped down as
CEO as activities in the United States are of lower priority. Dr Caspari remains a valued member of our board of directors. In resuming the responsibilities of CEO, I thank Dr Caspari for his work in 2008."
See http://www.lctglobal.com/downloads/cms_latest_news/2009-03-15-LCT%20Quarterly%20Newsletter.pdf.

So, good news on one hand, but probably meaningless for those of us who live on this side of the pond (or, from NY to NZ, many ponds?)

– Dov

Its interesting news, i have been following LCT for a while now. But its really hard to keep a positive attitude when you see how many “breakthroughs” there have been that just disappear never to be heard of again. Will LCT be one of them? I sure hope not!, as they seem like one of the few genuine research companies devoted to their cause of curing or at least seriously improving the life of type 1 diabetics as opposed to alternative treatments. I say LCT should set their sights on Canada for clinical trials, as they seem to be one of the leading countries when it comes to scientific research into type 1 diabetes

One hopes that with the US government’s current position on science (which, though it might be partisan of me to say, is not "fire bad!!! Oog put out fire!! Wheel bad! Oog smash wheel!!) that Diabecell will be able, if they can successfully “commercialise” their product in NZ, to bring it to market here with a relative degree of speed. I’m not so sure they’re concerned about the regulatory environment here as much as they want to take advantage of what I guess is a relatively non-burdensome regulatory environment in Russia. Simply put, if I’m reading their release correctly and they believe that they can commercialize in Russia immediately after phase I, they can start making money in Russia and use that to do the product testing necessary for other countries with a more robust regulatory scheme.

What does concern me, however, is the relative snail’s pace at which this project is proceeding. They enrolled something like 2 patients in 6 months. One suspects there are more diabetics than that in Russia.

Actually, I think the news about Dr. Caspari stepping down and the statement “activities in the United States are
of lower priority” are meaningless in terms of progress. The fact is that clinical trials are increasingly taking place outside of the U.S. (and other developed countries) largely because costs are significantly less elsewhere, plus the regulatory environment is generally more favorable, too. Ultimately, if the trials are successful, the next round of trials will still need to be compliant with FDA and EMEA guidance anyway, so I don’t really see this as an impediment to the ultimate goal of commercializing this as a treatment.

I meant that more in terms of penetration of the US market, rather than in terms of getting research to progress, which can happen anywhere. If, however, they get Diabecell approved in Russia and it still takes them 10 years to go through all the FDA-required testing, it does us all no good that it was approved, unless we want to go for a hop over to Russia for some surgery - which I think I’d avoid.

I’d go to Siberia for a proven cure. In the winter. With shorts on.

I supposed I just showed my US-centric view of the world, eh?

I believe this procedure is similar to Dr. Valdez of Mexico who did this xenotransplantation 15 years ago with good success. Dr. Valdez approached the University of Florida to contimue this research in the US, but I do not believe the study was conducted in the US. Dr. Valdez, in an in office minor procedure implanted the encapsuated xeno cells within subcutaneous tissue, and the cells produced insulin for about 5 years if I remember correctly. I will try to locate and then post the Cnadian Broadcast piece on the procedure. The point is that Dr. Valdez and his promising results were quieted and not pursued in the US. Why not?