Macrogenics study

So, tomorrow I’m supposed to go to St. Barnabas Medical Center to get tested to see if I’m eligible to enter the Macrogenics trial. My dad is an endo, and he’s impressed with what he read . . . anyone out there in the trial?

Send good thoughts my way, and let’s hope for no placebo :slight_smile:

– Dov

Can you give more info about the trial? I don’t know anything about it!

Keep us posted!! And hoping for no placebo for you too!!!

Kristin - thanks for the good wishes!

Essentially, it’s one of the honeymoon “save beta cells” treatments. It uses teplizumab, which is an anti-CD3 antibody. The treatment is supposed to extend the honeymoon period and help keep A1c under control, etc. From what I understand, it actually works, but can send liver enzymes out of whack in the short term.

Tomorrow I get to drink a special milkshake and have my blood tested every 30 mins for 5 hours. The nurse with whom I spoke tells me that they’ll know more about my blood than I’d ever want to know. If I pass, there are 2 rounds of 14 days of infusions, one fairly immediately and 1 six months later.

For information, see

Crossing fingers . . . .

Yes, please share! What is this trial?

All good thoughts sent your way. Fingers crossed.

Macrogenics signed a $1 billion deal last November with Eli Lilly and Company to commercialize teplizumab, which is a monoclonal antibody therapy which would essentially arrest the misdirected immune system attack on the pancreatic beta cells. That deal was assembled by JDRF. Trials on treatments like this have already been undertaken by U.C. San Francisco, and more recently, JDRF funded a study in several European countries to test the therapy, and the initial trials were successful in newly-diagnosed and/or at-risk individuals. The big unknown is whether such a therapy might also work on longstanding type 1 patients because no one has ever tested it on that group. The main issue is that at present, no companies manufacture the monoclonal antibody therapies, and it is extremely labor-intensive to make them for trials by hand, so having a drug company like Lilly making it would alleviate one of the main limitations on making such therapies available to a larger audience of patients. Lilly, no doubt, may try to expand the universe of eligible patients to also include longstanding type 1s, although it is unclear what timeframes those would follow if they do.

I hope you’ll share what your experience is in the trial, including what they tell you about eligibility! Good luck!

OK, so here’s the bad news . . . I have a clinically insignificant condition that means I have a high bilirubin count. No clinical significance, but my bilirubin excludes me from the survey. Guess I can kiss that extended honeymoon goodbye . . . .

Will post more on the study later, but just started work today and am obviously more than a little bummed out by the news.

Sorry to hear you missed out on the trial.

Thanks . . . well, there’ll be other opportunities to be a guinea pig, eh?

I am sorry it didn’t work out for you.

Good luck! It is well worth extending your honeymoon! We tried to get my niece into a trial when first diagnosed (Dr. Herald anti-CD3 monocloidal… forget the full name of the drug) but she was 8 years old and weighed 50 pounds. They would accept only 12 year olds and child had to weigh 80 pounds. Very disappointing. My niece’s endo is involved in research with teplizumab now at Naomi Berrie in New York. Believe me, if she was recently diagnosed and they would take her, we would try it! Hope you get the real thing, not the placebo. Go for it!!!

Sorry, Dov: I just read further down the thread. How about trying Diamyd? Excellent results with Diamyd. Do check it out. P.S. Just because high bilirubin excluded you from one trial, it may not exclude you from another. Don’t get discouraged. Honeymoon is limited amount of time, so check Diamyd and don’t stop there. Check other trials that sound encouraging as well.

Oh, Dov, so sorry to hear this:( Damn, what a horrible disappointment. More than a little bummed–sure that’s putting it lightly.

Teplizumab is the Dr. Herald drug in the study for which I was rejected.

Unfortunately, I’m too old for the Diamyd studies that are currently ongoing. Alas. Most of the other studies are either 6 weeks after diagnosis or are too far away for me to go (at least if I’d like to remain employed) - or involve drugs where my dad’s research said the side effects were way too high.

Thanks to everyone for the good thoughts!

The Macrogenics study has 2 trials: Protege and Abate. I’d look at the website of both of them (just google protege diabetes trial and abate diabetes trial), as they do not have exactly the same requirements. So may be your condition prevents you to participate from one of them, but not from the other. Give it a shot and good luck.

Unfortunately, it seems the bilirubin count is an unwritten exclusion for both studies - already checked. Oh well.