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.
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."
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?)