On Jan 7, 2010 Tolerx announced that they had completed enrollment of their DEFEND-1 clinical trial. This is a phase-III study which is randomized, placebo-controlled and includes 240 patients at over 100 sites all over Europe and North America. Because each patient is followed for a year, we can expect results from this study after January 2011.
The study is designed to evaluate whether a single course of otelixizumab, administered to type-1 diabetics during their honeymoon phase, will preserve insulin production.
Otelixizumab targets CD3 receptor on a T cell. The hope is that it will work in patients with type 1 diabetes who have residual beta cells by blocking autoimmune attack, while helping the "good" regulatory T cells that protect against the "bad" T cells, thus preserving the beta cells' ability to make insulin.
Press Release: http://www.prnewswire.com/news-releases/tolerx-completes-enrollment-in-defend-1-a-phase-3-type-1-diabetes-study-with-otelixizumab-80892467.html
Corporate Description: http://www.tolerx.com/index.php?page=trx4
Trial's Public Web site: www.DefendAgainstDiabetes.com
Diamyd Will Apply for Approval of Type-1 Treatment in 2011
Diamyd has announced that they expect to file the paperwork for market approval of their GAD65 targeted, type-1 treatment in 2011, after they complete the phase-III trials they have ongoing right now. Obviously, the headline is great, but remember these things:
- No results from their phase-III trials have been released, yet. They've got two different large phase-III trials going on right now.
- Applying for approval is great, but it usually takes a year or two to get it, after you apply.
- The current phase-III trials are all for honeymoon only, and so this approval will be for honeymoon only.
Even with all that, it would be great news to have something new approved for honeymoon type-1 diabetes. (Even if the short term result is likely to be just "uses less insulin" or "has longer honeymoon".) Right now, we have nothing like that. When they publish their phase-III results, we're likely to see how much of a cure this is likely to be, and for how many people.
Also, you might have seen a HULIQ headline "Approval of Diamyd's Diabetes Vaccine Set for 2011". That's an outright mistake. They expect to start the approval process in 2011, not finish it then. The process takes a year or two to complete.
Press release: http://www.tradingmarkets.com/news/stock-alert/dmydf_swedish-diamyd-medical-to-apply-for-diabetes-vaccine-approval-2011-737987.html
Novo Nordisk Receives US Approval for Victoza (liraglutide) for the Treatment of Type 2 Diabetes
This really isn't type-1 news by itself, but Liraglutide just got FDA approval, and this is the same drug that just started phase-II trials for type-1 diabetics, and that I reported on in January. So there are now at least two drugs (the other is Byetta) which are approved for type-2s and causes them to generate more insulin. If a treatment is found that ends the autoimmune attack, then these treatments might be paired with it to create a faster, more complete cure.
I'm optimistic about this approach, because there are now four drugs in phase-III trials which are targeted at ending the autoimmune attack, and at least two already approved drugs, another in phase-III trials, and several more in phase-II trials, which increase the insulin supply. So those two treatments together might represent a relatively quick path to a cure, if they both pan out and work well together.
News Article: http://money.cnn.com/news/newsfeeds/articles/marketwire/0580389.htm
Transition Therapeutics Announces Results of a Phase 2 Study of TT-223 in Type 2 Diabetes Patients
At one time it was hoped that TT-223 would help type-1 diabetics regrow their beta cells and generate more of their own insulin. However current testing is limited to type-2s (as in this trial). The good news is that it worked for type-2s: the treated group A1C dropped by about 1.13, while the untreated group dropped by only 0.22.
To me, this suggests that if we are successful at stopping the autoimmune attack, then TT-223 might be helpful in helping to regrow beta cells. But so far, there is no evidence that TT-223 would be helpful as a single treatment for type-1 diabetics.
Press release: http://money.cnn.com/news/newsfeeds/articles/globenewswire/182542.htm
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.