Possible Cures for Type-1 in the News (November)

Merck Cancels "Smart Insulin" (MK-2640) After Unsuccessful Phase-I Trial

This is the news everyone hoped we would not get.  After completing a phase-I trial of "Smart Insulin" (also known as MK-2640), Merck has decided not to move forward with it.  They have not published the results, but have published this: "MK-2640 was discontinued due to lack of efficacy".

News report:  http://www.pharmaceutical-journal.com/news-and-analysis/features/towards-a-smarter-insulin/20203828.article

Discussion

This was the first (and so far only) glucose responsive insulin to be tested in humans.  However, there are several "smart insulins" being tested in animals, not to mention "smart artificial cells" and "smart membrane" based technologies, all aimed at automatically regulating the amount of insulin in the blood stream.  I expect some of these to enter human trials in the next few years.  So "smart insulin" may yet be a trail blazer, even if it itself was unsuccessful.

If results from this study are ever published, I'll blog on them here.  However, there is nothing forcing Merck to publish these results if they don't want to.

Phase-II T-Rex Trial Update

Caladrius Biosciences recently announced that they had enrolled the 70th patient (out of 111) in their clinical trial of CLBS03 for T1D.  So it has taken them roughly 18 months to recruit 2/3 of the patients they need.  If they can keep up that pace, they will finish recruiting in the third quarter of 2018, and finish collecting data in the third quarter of 2019, and publish in 2020.

Previous Blogging: http://cureresearch4type1diabetes.blogspot.com/search/label/Polyclonal%20Tregs

A quick summary of this treatment is as follows: remove one specific type of T regulator cell (called "CD4(+)CD25(+)CD127(lo)") from a person with type-1 diabetes.  Grow them out so you have about 500 times more, and then put them back in the same person.  Since regulatory T cells naturally regulate the body's immune system, and the patient now has more of them, the hope is that they will prevent the autoimmune attack which causes type-1 diabetes.

They are recruiting patients in about 15 locations all over the US, so read the clinical trial registry to get a complete list and some contact information.

News Report: https://www.caladrius.com/press-release/caladrius-biosciences-announces-enrollment-of-the-70th-subject-in-the-phase-2-t-rex-clinical-trial-of-clbs03-for-type-1-diabetes/
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT02691247

SIMPONI (Golimumab) Starts A Phase-I Trial In Pre-Symptomatics

Golimumab (sold as Simponi) is an immune system modulator, which has been approved in the United States and many other countries for treatment of several autoimmune diseases, so testing it on type-1 diabetes makes a lot of sense.  This is the second trial underway for this drug.  (The other one is called T1GER, and is for honeymooners.)  Simponi has already been approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.

This study is recruiting people who have two autoimmune antibodies (but no other symptoms of type-1 diabetes). They are recruiting 30 kids (aged 6-21), and will follow them for 17 months. Each kid will get 26 weekly injections.  Half the patients will get Simponi and the other half will get a placebo.  They hope to finish this study in mid 2021.

This study is current recruiting in Linkoping University Hospital, Linkoping, Sweden, SE 58185.
Study contact: 844-434-4210 JNJ.CT@sylogent.com
They hope to start recruiting at other locations in Sweden and Finland soon.

The unusual thing about this trial is that they will not measure any effectiveness data at all.  The only data gathered will be safety and side effect data.  No C-peptide data, no A1c, or insulin usage.  That's very unusual for a type-1 diabetes study.  In my experience, even the phase-I studies gather some effectiveness data.

Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT03298542
Previous Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02846545

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 or JDCA 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.

Golimumab / SIMPONI Starts a Phase-II? Trial (T1GER)

Golimumab (sold as Simponi) is an immune system modulator, which has been approved in the United States and many other countries for treatment of several autoimmune diseases, so testing it on type-1 diabetes makes a lot of sense.  It has already been approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.

The Study

This study will enroll 81 people.  Half will get the treatment, and half will get a placebo, as the study is double blind.  The treatment is a subcutaneous injection once a week.  This is the same kind of injection used for insulin itself.  Everyone will be followed for two years.  The primary data will be C-peptide generation (a marker for natural insulin production), and the secondary data includes A1c, insulin usage, side effects, more C-peptide data, etc.

They started in August 2016 and plan to run until October 2019.

The researchers are planning on recruiting at 30+ different locations throughout the United States. Their clinical trials page says that right now they are only active in Atlanta, Georgia and Lexington, Kentucky. However, I do think they are actively recruiting in Walnut Creek, California as well. (People often forget to update their clinical trial record as they add more sites.)   The contact point for enrollment is this email address: JNJ.CT@sylogent.com.

Discussion

Golimumab is a monoclonal antibody (meaning it very specifically targets one type of cell). In particular, Golimumab targets TNFα (Tumor Necrosis Factor alpha) an immune signalling protein, which triggers several immune responses, including inflammation.  This is slightly controversial because researchers such as Dr. Faustman are trying to cure type-1 diabetes by increasing the levels of TNFα, while these researchers are trying to cure type-1 diabetes by decreasing the levels of TNFα. This issue came up in 2009, when Embrel (which lowers TNFα) had a mildly successful Phase-I trial. I discussed the "TNFα: Friend or Foe" at that time:
http://cureresearch4type1diabetes.blogspot.com/search/label/ENBREL

This study is being done by Janssen Research and Development, which is a large pharmaceutical company.

Clinical Trials Registry: https://clinicaltrials.gov/ct2/show/study/NCT02846545
Drug Web Page: http://www.simponi.com/
Drug Wikipedia Page: https://en.wikipedia.org/wiki/Golimumab
TNF  Wikipedia Page: https://en.wikipedia.org/wiki/Tumor_necrosis_factor_alpha

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 or JDCA 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.