Working to Cure Type 1 Diabetes

[Keith Ranville]

Diamyd


Diamyd Medical shall prevent or cure autoimmune diabetes with its patented GAD65 immunization.

NIDDK (TrialNet) sponsored phase II GAD trial fully recruited

Good news!
The NIDDK sponsored GAD trial is fully recruited (126 patients).

This is much faster than expected thanks to the big TrialNet network. The follow up period is 2 years and this means that we will have Phase III data from the European trial first and then some additional data from the American Phase III trial and this NIDDK Phase II trial.

The fact that no adverse side-effects have been seen is very good considering they want very young children to be getting this drug (if approved).

Additional new trials are planned, unclear if this means GAD65 specific or not.

"TrialNet is currently planning additional new onset studies that will be launched later this year."

Now we wait and see. Will the data be good enough to produce a drug which slows down the disease (I believe so), will the data show that the disease is completely stopped (I hope so!)

Posted by webmaster at 9:40 PM 0 comments Links to this post 

Labels: diamyd, gad65, phase II, trialnet

Friday, March 26, 2010
Diamyd receives Orphan designation and US Phase III update

On the 10th of March we received some updates on how the US Phase III trial is progressing. Around 100 of 320 have been enrolled which is fewer than expected. The European Phase III trial was fully enrolled in November 2009 and is now in follow up with results expected Q1-Q2 2011.

Why is the American trial so slow to enroll patients, I don't know. They might have more experimental treatments to choose from or they might be less positive to enroll their children in experimental trials.

My hope is that the trial is fully enrolled by the end of this year. I also hope that the European trial is enough to receive a approved drug from the European authority but I suspect that they will want to wait for the US Phase III trial to also be completed. The extremely good safety record might work in favor of a approval without the US trial.

The 23rd of March Diamyd received Orphan drug designation which gives "qualify for seven years of market exclusivity from the date of US marketing approval, tax credits for clinical research and a waiver for FDA user fees". The designation gives no real benefit to the patients except shorter approval times; but it's good for the company which is still pushing along without any help from larger pharma.

Looking forward the results and hoping not only for statistically proven results but also that Diamyd can stop the beta cell degradation. It might be a long shot, but it's not impossible that giving Diamyd during the honeymoon period will prolong it indefinitely.

Take care!

Posted by webmaster at 7:12 PM 0 comments Links to this post 

Labels: diamyd, orphan, phase III

Saturday, November 14, 2009
European Phase III fully recruited

Diamyd anounced today that one of their Phase III trials for the Type 1 Diabetes vaccine is fully recruited.

The trial includes 320 persons and the initial followup time is 15 months. This means that we will have result from this Phase III trial in spring 2011. This is about a 6 month delay from the initial estimates but from now on the 15 month clock is counting down.

Good news!

What next? The US Phase III trial is still recruiting and I estimate it will be fully recruited in 3-5 months. This gives us two completed Phase III trials for fall 2011 which can be evaluted by the FDA and EMEA. I will expect a lot of buzz during the release of the European results in spring 2011 and then many will wait for confirmation of the results with the US trial 3-5 months later.

I truly hope this drug will be effective in saving beta cells, prolonging the honeymoon and maybe, if given really early stop the outbreak of T1D completely.

Posted by webmaster at 1:34 PM 38 comments Links to this post 

Monday, June 22, 2009
Diamyd : Prevention vs Intervention, why should we care?

Long time since last entry and some news regarding the Diamyd GAD65 trials to prevent or improve Type 1 Diabetes.

Today we got news that the prevention trial mentioned before has started and three children have been treated. Why is this important and what differs this trial (prevention) from the other trials (Phase III Intervention)?

We have very good ways of screening children for Type 1 Diabetes. With that information Diamyd is trying to see if early injections with GAD65 will not only preserve beta cells but actually stop the disease before outbreak. Prevention trials take 5+ years to give good enough data, but just because it takes a long time doesn't mean it's not worth doing. Phase III Intervention trials are running in parallel, both in Europe and in America (actually three separate trials are done in America).

We have also news that the American part of the Phase III trial is reducing the minimum age to 10 years (from 16 years). This will reduce the time it takes to enroll patients.

Looking at older plans, Diamyd was planning to have enrolled all 640 patients in the two Phase III trials. As usual delays are a part of this kind of research and now we are looking at end of 2009 for the last patient to be enrolled (delay of 6 months).

Overall it looks good! Safety is the key here, and a safe drug that works a little is 10 times better than a dangerous drug that works good (well not always, but while treating children!!). So we are still waiting for Phase III data, planned Q1 2011, fingers crossed.

Have a nice summer!

Posted by webmaster at 5:23 PM 1 comments Links to this post 

Labels: gad65, phase III, prevention, type 1 diabetes

Sunday, March 15, 2009
Diamyd trials update

Much has happened in the last few months.
Here is a picture to illustrate the trials currently ongoing and when they (if data is available) will present the results.

As you can see, Phase III results are expected in fall 2010, and FDA/EMEA approval (if granted) is expected to take 6-9 months.

Click on the image to make it larger.

Posted by webmaster at 10:36 AM 0 comments Links to this post 

Wednesday, March 11, 2009
Trialnet starts trial using Diamyd vaccine

Trialnet will start the Diamyd Phase II trial at 15 clinics in the US.
This study will include 126 patients and add to the data planned to be received by the Phase III trials currently ongoing in the US and Europe, and the Combination trial mentioned earlier also supported by the NIH/NIDDK.

The group of 126 patients will be placebo controlled and given 3 injections of either GAD65 or Placebo. To be included in this trial you have to be newly diagnosed (3 months) and be within 16 - 45 years old.

After a while the age requirement will drop to 8 years and at the end of the trial probably even down to 3-4 years of age. This acceptance of very low ages is made to accommodate for the Trialnet prevention trial planned to start this year.

Recruitment is planned to take 6-9 months and first results can be expected in the first half of 2011 (we have Phase III results in fall of 2010).

Trialnet Chair Dr Skyler has the following to say:
"We are pleased to announce the launch of this trial, which will employ state-of-the-art technology to investigate the vaccine's modulation of the immune system to induce immune tolerance in type 1 diabetes. We look forward to studying the vaccine's effect and mechanism of action at TrialNet's 15 clinical centers in North America,"

This trial is another step on the way to secure that Diamyd (GAD65) is effective in slowing down or completely stopping the auto-immune reaction which destroys the beta cells.

Safety
VERY important to hear that FDA will allow younger children to try out this drug. Don't get me wrong, i'm not for testing unproven drugs on children, but for me this proves that Diamyd indeed has a strong safety profile. Compare to for example to TolerX, DiaPep and Macrogenics (teplizumab) who all have a range of side effects.

In less than 2 years we will get first data from Phase III trials. Then more data will continue to drop in as the patients are followed for a few more years. If results in Phase III trials looks as good as Phase II results published in NEJM, the drug can be on the market early 2012.

I'm hopeful and glad that we have this range of trials so results will be definitive.

If you want to read about other possible cures for T1D, I recommend cureresearch4type1diabetes by Joshua Levy.

Posted by webmaster at 5:38 PM 16 comments Links to this post 

Labels: clinical trials, diamyd, gad65, niddk, trialnet, type 1 diabetes

Wednesday, March 4, 2009
Second Diamyd type 1 diabetes prevention trial started

Today the second Diamyd (GAD65) prevention trial was approved by the Swedish medical authorities.

It will be conducted at Lund University hospital in Sweden.
The trial will include 50 children from 4 years of age, randomized and placebo controlled.

The fact that children as young as 4 years old where approved for this trial is good evidence on the amazing safety profile Diamyd (GAD65) has shown so far.

"To stop the immune attack on the insulin producing cells in type 1 diabetes may be easier the sooner it is done in the disease process", says Professor Åke Lernmark, at Lund University, Sweden. "It is like steering a big boat away from a threatening collision. The sooner the course is changed, the better. A timely change in the course of the disease - no insulin injections - that may be this century's contribution to curing autoimmune diabetes. Last century's contribution? Insulin injections!"

Now we are only waiting for Trialnet to also start the US prevention trial, using identified high-risk patients identified in the Natural History Study.

Source:
Diamyd Press release
http://www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=498


http://diamyd.blogspot.com/













http://www.diamyd.com/

[Keith Ranville]

Press Release Stockholm, March 4, 2009

Pioneering Diamyd® Study to Prevent Childhood Diabetes Approved
Diamyd Medical announces today that the Swedish Medical Products Agency has approved a study with the Diamyd® diabetes vaccine in children with high risk to develop type 1 diabetes.
At Malmö University Hospital, Lund University in Sweden, large screening tests results in a continuous identification of children that are subject to a very high risk of developing type 1 diabetes. By measuring different biomarkers in blood samples, it is possible to determine in an early stage that these children are in the autoimmune disease process that destroys their insulin producing cells. If vaccination with Diamyd® succeeds to intervene in the disease process before too many of the insulin cells are destroyed, the disease will be prevented. The child would then escape diabetes symptoms and would not become dependent on insulin injections for survival, which otherwise is unavoidable.

"We meet with these kids every third month and we know that virtually all of them will present with type 1 diabetes. Many of us pediatricians have been frustrated not to be able to interfere. But now, and I have to admit it feels almost a bit unreal, we may for the first time have a real opportunity to save these children from the disease," says Helena Elding Larsson, pediatrician from Malmö and researcher at Lund University in Sweden.

The approved study comprises, under the present approval, up to 50 children from 4 years of age who are known to have a high risk of developing type 1 diabetes. The study will be randomized and placebo controlled.

"To vaccinate children against diabetes has from the outset been one of Diamyd Medical's long term goals," says Elisabeth Lindner, President and CEO of Diamyd Medical. "Type 1 diabetes is a life-long and very serious disease and it is good if we now can prevent it. It would avoid a lot of anxiety, suffering and costs for the children and their families as well as the rest of Society."

Diamyd Medical was founded 15 years ago with the vision to treat and prevent type 1 diabetes with the GAD-molecule, which is the active ingredient in Diamyd®. The vaccine was first studied in adult so called LADA patients, where the Diamyd® vaccine showed it could prevent the need for insulin injections. In a more recent Phase II study, Diamyd® treatment of children and adolescents with type 1 diabetes and a certain remaining endogenous insulin production lead to a clearly improved disease process. The results from this study were published in the New England Journal of Medicine in October 2008. Large Phase III studies in children and adolescents, who recently have been diagnosed with fully developed type 1 diabetes, are now ongoing. Diamyd® treatment has not raised any safety concerns in any study and this strong safety profile has resulted in that Diamyd® now can be studied for prevention of childhood diabetes, according to the Company's original idea.

"To stop the immune attack on the insulin producing cells in type 1 diabetes may be easier the sooner it is done in the disease process", says Professor Åke Lernmark, at Lund University, Sweden. "It is like steering a big boat away from a threatening collision. The sooner the course is changed, the better. A timely change in the course of the disease - no insulin injections - that may be this century's contribution to curing autoimmune diabetes. Last century's contribution? Insulin injections!"

The Diamyd® diabetes vaccine has mainly been developed in Sweden, but with help from leading expertise from all over the world. Diamyd Medical's scientific advisers include Professors Hans Wigzell, Karolinska Institute, Stockholm, Sweden; Lars Klareskog, Karolinska Institute, Stockholm, Sweden; Åke Lernmark, University of Lund, Sweden; Johnny Ludvigsson, University of Linköping, Sweden; David Leslie, University of London, United Kingdom; Bart Roep, Leiden University, the Netherlands; Jerry Palmer, University of Washington, USA; Mark Atkinson, University of Florida, USA; Daniel Kaufman, University of California, Los Angeles (UCLA), USA; Allan Tobin, UCLA, USA and Joe Glorioso, University of Pittsburgh, USA.


About Diamyd Medical:
Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company's most advanced project is the GAD-based drug Diamyd® for type 1 diabetes for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has started clinical studies within chronic pain, using its Nerve Targeting Drug Delivery System (NTDDS). The company has also out-licensed the use of GAD for the treatment of Parkinson's disease.

Diamyd Medical has offices in Sweden and in the US. The share is quoted on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further information is available on the company's web site: www.diamyd.com.

(www.omxnordicexchange.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)

For further information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.), elisabeth.lindner@diamyd.com
Phone: +46-8-661 00 26

For pictures and press material, please contact:
Sonja Catani, Chief Communications Officer Diamyd Medical AB (publ.), sonja.catani@diamyd.com
Phone: +46-8-661 00 26

Diamyd Medical AB (publ.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com. VATno: SE556530-142001.

This information is disclosed in accordance with the Securities Markets Act, the Financial Instruments Trading Act or demands made in the exchange rules.
http://www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=498

[Keith Ranville]

Apparently clinical trials are going on in america, regarding a type 1 diabetis flu shot? so far things look promising from the clinical trials thus so far, according to the local news in vancouver? 


Keith,