Diabetes Type 1 Vaccine - Diamyd(R) Phase III Study Approved By Six European Countries

http://www.medicalnewstoday.com/articles/128454.php

Not much info in the article about how it works, but if I remember correctly, I first saw this announced in 2005. It woks by interfering with the T-cell that attacks the beta cells so the T-cell can no longer attach itself to the beta cell and destroy it.

Sounds very interesting, esp if you were to combine this type of treatment with some of the others recently announced that may be able get beta cells to regen.

Of course, we’ve all been hearing about treatments that “could” cure T1 forever, so I’ll believe when I see it

Scott, you might be thinking about ToleRX

“It woks by interfering with the T-cell that attacks the beta cells so the T-cell can no longer attach itself to the beta cell and destroy it.”

Diamyd works by introducing small amounts of GAD65 (GAD vaccine), so the immune system learns to tolerate it.

I thought I would just add the following: some additional detail on their manufacturing plans for the vaccine; specificially details on the company they’ll be partnering with to make their type 1 DM vaccine:

Manufacturing of Diamyd® In December 2005, Diamyd Medical entered into a manufacturing agreement with Protein Sciences Corp, based in Meriden, Connecticut, U.S.A, ( http://www.proteinsciences.com/) for production of clinical grade Drug substance (GAD protein) for future clinical trials. This info comes from their 2005 annual report, but may be of interest.

http://www.diamyd.com/docs/PressClip.aspx?PageID=4&ClipID=464

http://www.medicalnewstoday.com/articles/128454.php

Have you folloved th LADA studie from Diamyd ? If you accept that juvenil and adult diabetes treated with insulin is the “same” disese (autoimmun attack). There is some intresting reading about this. There has recently been released 5 years result from a Fas IIa studie. It is from a quite small group but still. After 5 years in the GAD-Alun treated group 14% needed insulin. In the placebo group 74% needed insulin. You may ask your self where is the rest of the studies. At this moment there is non and there are no planned. There where a Fas IIb ongoing with 160 patients, but it was deklared as not guilty. The reason where the controll results where not possible. Probably the company (swedisch gouverment’s chemisty) did mix placebo and GAD-Alun. Insted of doing a new studie Diamyd carried on with juvenil diabetes. Whitch is very strong normaly you test on adult before on children. This time it will be the opposite. At the moment Diamyd are doing one Fas III Europe (beginn jul 08)
http://clinicaltrials.gov/ct2/show?term=gad65&rank=1
and one in USA (beginn aug 08)
http://clinicaltrials.gov/ct2/show/NCT00751842?term=diamyd&rank=4
And Trialnet a third one (beginn dec 08)
http://clinicaltrials.gov/ct2/show/NCT00529399?term=gad65&rank=5
And probably there will be preventions studies beginning middle 2009.
The reason for preventionstudies are that there are to less insulin-producing cells (<10%) to save when it is diagnosed. This means probably the patients will need some extra insulin. The antibodies are there a long time before and about 80-90% will be ill in a short time.

They’re actually planning LADA studies in 2009. They had good LADA results from some prior studies before the one that got botched, and because of the botched study, they got set back a bit. Forgot where I read that; will try to track it down.

As far as I know they are not planning new LADA studies. Probably it will be able to treat LADA patient on the indication insulin treatment, if GAD-Alun will recive a FDA acknowledge. The diagnose LADA or juvenil diabetes is only akademic. From the point age, Both groups need insulin. I can see that you are familar with diabetes 1.5.
At the moment it is a moneyproblem, Diamyd cant afford more studies. Therefore they are going on with the children first
Here are the studie with five years result. (As you can see I was wrong not 74% should have been 64%)

http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={FB6C7AF9-CE4B-4EC2-8817-B88FB685A041}&MKey={D4A66D7C-BA0B-404F-9FDC-B8B6944A923D}&AKey={3B7B2FB4-D207-4884-AE88-132BE0AFCDBB}&SKey={E701452F-02F3-4BD3-B857-E1108310E61A}

Oboy. I tryed to edit, but I was too slow. You have to do it the difficult way. I hope it will work better :wink:

http://www.easd.org/

On bottom middle you will find:

Abstracts of the 44th
EASD Annual Meeting

Choose:

Use Advanced Search to find more specific results.

On this side you will find “Presentation Number:”

give in 565

From here you will have some diffrent ways, but that you will find out by your self.