Monday, March 31, 2014

Possible Cures In The News (March)

Here are some bits and pieces of research, that I found interesting:

GAD65 Not Effective for LADA

GAD65 is one of the molecules targeted in the autoimmune attack which leads to type-1 diabetes.  A company called Diamyd, developed it as a honeymoon cure for type-1 diabetes.  The hope was it would train the immune system not to attack pancreas cells, and that would stop type-1 diabetes. It looked OK in phase-II trials, but failed phase-III trials a few years ago.

However, there were a few other studies underway when the phase-III data came in, and this is one of those studies.  The researchers were giving GAD65 to people who had LADA (Latent Autoimmune Diabetes of Adults).  LADA is a not separate form of diabetes, but a name given to people who have type-1 diabetes, but are diagnosed in adulthood (usually over 25).

In this trial, GAD65 treatment had no effect.

Abstract: http://care.diabetesjournals.org/content/early/2014/03/04/dc13-1719.abstract?papetoc


Non-Cure Research

When Does Type-1 Diabetes Start?

Currently, type-1 diabetes is diagnosed when symptoms are seen.  Usually, those symptoms are signs of high blood sugar: excessive urination and thirst, unexplained weight loss, lack of energy, etc.  More recently, some people have been diagnosed because their after meal blood sugar spikes above 200, even before the other symptoms are seen.

But now, there is some discussion that maybe we should change the definition of type-1 diabetes even earlier.    You can read about that in the link below:

JDRF News: http://bayarea.jdrf.org/blog/redefining-diagnosis/

Another Veo Safety Study

The Medtronic Veo is the first (very small) step to an artificial pancreas.  It shuts off for a few hours if blood sugar levels go low for too long.  This could be a huge step forward in preventing "dead in bed" fatalities, which are a significant cause of death for people with type-1 diabetes.

Anyway, there was a clinical trial to find out what would happen if the Veo cut off insulin incorrectly, when the BG levels were high (instead of low).  This is the exact opposite of what the Veo is supposed to do, and it has not been seen to happen in actual use.  However, the idea was to test to see what would happen, if the pump failed in this way.

The researchers found that even if this failure occurred, nothing bad happened to the person using it.  So that gives an added level of safety for this product (and presumably similar products, when they come to market in the future).

Abstract: http://care.diabetesjournals.org/content/37/3/773.abstract?etoc

Future Postings

I'm currently working on three blog postings, which I hope to get out in the next month, but obviously, I'm way behind, so no promises.  And I don't know what order they will come out in:

  • Dr. Damiano's Bihormonal Artificial Pancreas
  • Dr. Faustman's Phase-II study of BCG
  • General Update on AAT 


Joshua Levy
http://cureresearch4type1diabetes.blogspot.com 
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

Monday, March 3, 2014

Imatinib ("Gleevec" / "Glivec") Finally Starts a Phase-II Clinical Trial

A year ago, researchers (Drs. Gitelman and Bluestone) at UCSF filed the paperwork to start a clinical trial testing Gleevec on people.  Now, they can finally start enrolling people in the trial.  The generic name for this drug is Imatinib.  It is sold as Gleevec in the US and Glivec in most of the world.

Gleevec is a drug already approved for treating cancer.  Patients will take a daily pill, will visit the clinic at 2 weeks, then monthly for the first year, and after that twice per year.  The researchers will measure C-peptide (to see if patients are generating their own insulin) as well as how much injected insulin the person needs, and their A1c numbers.

I've previously blogged on this trial here:
http://cureresearch4type1diabetes.blogspot.com/2013/02/possible-cures-for-type-1-in-news-mid.html

I also created a "Timeline of Gleevec as a Potential Cure for Type-1 Diabetes" that you can look at.  This timeline is experimental, so if you have any suggestions on how to make ti better, please email them to me.

They are hoping to finish collecting data in 2016 and complete the trial by 2018. It is a 66 person trial (44 will get the treatment, 22 will be in the placebo group). But this is a honeymoon trial, only people within 100 days of diagnosis will be included. Imatinib is a relatively new cancer drug, which is popular because it targets an enzyme that only cancer cells have, so it is relatively non-toxic to non-cancer cells. (The buzzword is "targeted".) The obvious question is, why would it be expected to work on type-1 diabetes?  It's not clear (at least to me) exactly why Gleevec should stop type-1 diabetes.  It does target parts of the immune system and it does lower inflammation, so either one of those (or both) could be it's mechanism of operation.  Or, it could be something completely different.  The work done in mice suggests that it might be the last option: a completely different mechanism, but there is not enough data to be sure.

Unfortunately, right now, they are only recruiting patients 18 years and older (an FDA limitation). Since this is a honeymoon trial, that is a serious limitation, and will make it hard to find people to recruit. The hope is that after some adults are successfully included in the study (and no safety issues come up), they will be able to lower the recruitment age for future patients, and fill the rest of the trial more quickly.

They are recruiting at several locations:
San Francisco: Contact: Chrinstine Torok, RN 415-502-9089 torokc@peds.ucsf.edu
Denver Contact: Jennifer Smith 303-724-8272 jennifer.e.smith@ucdenver.edu
Indianapolis Contact: Jennifer K Terrell 317-944-2584 jkramey@iu.edu
Omaha Contact: Chris Smith 402-280-4319 christosmith@live.com
Philadelphia Contact: Charles Isaacs 215-590-7222 isaacsc@email.chop.edu

Wikipedia: http://en.wikipedia.org/wiki/Imatinib
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01781975
Orange Book Entry: http://www.accessdata.fda.gov/scripts/cder/ob/docs/temptn.cfm

Joshua Levy
http://cureresearch4type1diabetes.blogspot.com 
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.