Alefacept Reports on Phase-II Results

Alefacept is a drug that has been used to treat the skin condition, psoriasis. Psoriasis is generally considered to be an autoimmune disease, similar to type-1 diabetes, but with the body attacking it's own skin cells, rather than it's own beta cells. So trying a drug already approved for Psoriasis on type-1 diabetes seemed like a reasonable thing to do, and these researchers did it. You can read my previous blogging here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Alefacept

This was a honeymoon trial. 33 people got the drug and were compared to 16 who did not. The treated group got a dose a week for 12 weeks, then a 12 week break, and then weekly doses for 12 more weeks.  This publication is the two year follow up; they have already published a one year follow up.  The graphs below summarize the main findings.

For me the "A" and "C" graphs are the important ones.  The "A" graph (upper left) shows that untreated people's C-peptide levels did not drop in the first year, and even in the second year,they dropped less than the placebo group.  Remember that generation of C-peptide measures how much insulin the body is naturally producing, so more is better.  The "C" graph (lower left) shows that untreated people used about 30% more insulin after two years, which is also a good result, especially when graph B shows that both groups had the same A1c numbers.

Discussion

Cure Results
My reaction to this is the same "boilerplate" reaction that I've had recently to other honeymoon research where the untreated group got worse, and and the treated group held steady, so at the end of the study, there was a statistically significant difference between the two:

I think I was much more excited about them in the past.  Part of my lack of excitement now is that the treatments with these results that I saw a few years ago have not progressed. They don't give better results in more recent studies.  That might be because the research is taking longer than expected, or it might be that getting a small result is much easier than getting a useful (to patients) result.  But in any case: I haven't seen forward progress in other treatments with similar initial results, so I've become less excited about these kinds of results, in general.

So in general, these results go in my "good start, but more is needed" category of results.
I like them; I think they represent potential, but I'm not excited by them.

Treatment Results
If you look at chart D above you can see that the people who took Alefacept had half as many low blood glucose events, as those who were not treated, and this was statistically significant.  From a treatment point of view, this is an interesting finding.

Not Moving Forward
Unfortunately, in a certain sense, none of this matters.  The company that made Alefacept stopped production in 2011, so it has not been available for years.  I don't know of any planned clinical trials with Alefacept, nor any similar fusion proteins.

COMPare:  +16/16 (100%)

Primary outcome given less prominence than secondary.           

COMPare is an experimental methodology for reporting switched or misreported results.  As my own experiment, I'm going to report on COMPare metrics for all results that I blog about in 2016.  I will explain this methodology in a blog posting in a week or two.  So the text in green should make sense then.  For now: this study has a very good COMPare score.

Discontinuation: https://www.psoriasis.org/media/press-releases/amevive-alefacept-voluntarily-discontinued-us
Press Release: http://www.eurekalert.org/pub_releases/2015-07/bri-apb071615.php
Abstract: http://www.ncbi.nlm.nih.gov/pubmed/26193635
Full Paper: http://www.jci.org/articles/view/81722


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.

Possible Cures for Type-1 in the News (early January)

This posting covers two news items and discussion to go with each.  I'm about 4 months behind on blogging about current events that might lead to a cure or prevention of type-1 diabetes.  Even after this posting, I'll still be several months behind.  I hope to catch up by end of January.

As you read these summaries, remember that C-peptide is generated when your body makes it's own insulin, so more C-peptide means your body is generating more of it's own insulin.

Results from Alefacept in a Phase-II Trial ("T1DAL")

Alefacept is a drug that has been used to treat the skin condition, psoriasis.  Psoriasis is generally considered to be an autoimmune disease, similar to type-1 diabetes, but with the body attacking it's own skin cells, rather than it's own beta cells.  So trying a drug already approved for Psoriasis on type-1 diabetes seemed like a reasonable thing to do, and these researchers did it.  You can read my previous blogging here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Alefacept

This was a honeymoon trial.  33 people got the drug and were compared to 16 who did not.  The treated group got a dose a week for 12 weeks, then a 12 week break, and then weekly doses for 12 more weeks.  They will be followed for 2 years, but these results only cover the first year.

Results

There were six results:
1. A two hour after eating C-peptide test: Treated generated about 0.130 nmol/L more than untreated, but this was not statistically significant.  However, all the rest of the results were statistically significant:
2. A four hour after eating C-peptide test: Treated generated about 0.171 nmol/L more than untreated.
3. Daily amount of insulin used: Treated people used about 25% less insulin.
4. Number of low BG events: Treated people had 10 such events vs. 17 in untreated.
5. No difference in A1c numbers between treated and untreated groups.
6. No serious adverse effects occurred.

Discussion

This is a good news / bad news kind of study.  I'll give you the bad news first:
* Because the first measure was the primary end point, this trial failed it's primary end point.  The others were secondary end points, some of which were successful.

Good news second:
* In for both of the C-peptide numbers, the treated group actually went up (a tiny amount) in the year after diagnosis, while the untreated group went down. So it is possible, that using this drug earlier in the process will preserve more beta cell function.
* Using 25% less insulin (with no difference in A1c numbers), and having half the low BG events both seem promising to me as well.

But the important thing to remember about this study, is that Alefacept is no longer on the market.  When this study started, it was being sold as an anti-Psoriasis drug.  However, the manufacturer withdrew it from the market while this study was running.  (The study was a little smaller than planned, because of that.)  The drug was not subject to any kind of recall prior to the withdrawal.

Because the drug is no longer on the market, I'm not sure if this research will move forward or not.

News: http://medicalxpress.com/news/2013-09-psoriasis-drug-results-diabetes.html
Abstract: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(13)70111-6/abstract
Web page: http://www.immunetolerance.org/news/2011/04/itn-announces-enrollment-first-participant-t1dal-trial-people-recently-diagnosed-type-1
Recruiting web site: http://www.t1dal.org/
Clinical Trial: http://www.clinicaltrials.gov/ct2/show/study/NCT00965458

Official Notice of Withdrawal: http://www.amevive.com/Patient%20letter.pdf


Results from Extended AAT (Glassia) Phase-I/II Trial

There are two pieces of news on AAT.  One is the results of an extension to their phase-I clinical trial, the other is informal news of a specific case study.  In this blog posting, I'm only covering the phase-I trial.  I'm gathering more information on the case study, and will present that in a future blog posting (probably at the end of January).

AAT is an anti-inflammatory chemical which the body makes naturally, and which is already FDA approved for people who have a rare condition where they don't make enough of it on their own.  There are several clinical studies going on, which use AAT.  In October, one of those studies released data on 20 people who were followed for 20 months after diagnosis.  There was no control group for this phase-I study. You can read more about AAT here:
http://cureresearch4type1diabetes.blogspot.com/p/drugs-and-treatments-in-clinical-trials.html

and my previous blogging here:
http://cureresearch4type1diabetes.blogspot.com/search/label/AAT

Results

Three results were reported:
* 60% of the patients where generating more than 0.2 nmol/L of C-peptide.
* 75% of the patients had an A1c of 7.5 or lower.
* No safety issues were found.

Because there was no control group, I can not directly compare these results to an untreated group of people.  However, my understanding is that both of these numbers are better than expected without treatment.  So this looks like good news, although not cure-type news, and without a comparison group, it's hard to tell.

Next Steps

Kamada is planning a phase-II/III study with 190 people.  The plan is for a double-blind, placebo-controlled, multicenter study on honeymoon type-1 diabetics.   The study will follow people for two-years measuring C-peptide parameters, HbA1C levels, hypoglycemic events, insulin daily dose, safety/tolerability, etc.  They will start in Israel, and expand elsewhere later.

Press Release: http://www.kamada.com/press_item.php?ID=73
The new study: http://clinicaltrials.gov/ct2/show/NCT02005848

Factoid: Type-1 Prevalence in USA Might be 1 in 500

Ten years ago, when my daughter was diagnosed, we were told that about 1 in 250 or 300 people had type-1 diabetes.  Over the years I've seen those numbers repeated many times for the US population, and they seem to fit in with what we see in schools.  Many with a few hundred students have zero or one type-1 diabetics, and those with several hundred often have one or two.   So it all makes sense.

However, a study recently published suggests that the actual number might be just under 1 in 500.  You can read the details at the link below, but they found a prevalence of 1.93 per 1000 in kids 20 and under:

Abstract: http://care.diabetesjournals.org/content/early/2013/09/11/dc13-1838.abstract.html?papetoc


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.

Possible Cures for Type-1 in the News (June-2012)

News About Diabetes News

The biggest diabetes research meeting in the world is the American Diabetes Assoication (ADA) Science Sessions, which are in June (this year: June 8-12).  It is followed by the big European Association for the Study of Diabetes (EASD) Annual Meeting (this year: Oct 1-5).  So expect a lot of news over the next few months.  We are already seeing press releases from companies publicizing what they will report at these large meetings.

Phase-II Results from Autologous Hematopoietic Stem Cell Transplants by Li at Nanjing University

This is the third group to do a Burt-like cure for type-1 diabetes, and get similar results.
You can read my previous blogging here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Burt

But the basic summary is this: for recently diagnosed type-1 diabetics, this is the closest to a cure there is.  People have gone years after this treatment without needing to inject insulin.  This result has been reproduced in both Poland and China, after originally being done in Brazil.  The down side?  Safety.  This treatment requires a full immune reboot.  Very approximately: They kill off your old immune system, and you regrow a new one, so for a few days (or a few weeks) you are very susceptible to infections and you stay in a special isolation ward in a hospital.  As far as I know, no one has died, but the risk is there.  Plus, there are long term risks.

From the abstract:

After [treatment], 11 of 13 patients required significantly reduced doses of insulin for adequate glycemic control, accompanied by reduced levels of glycosylated hemoglobin but increased C-peptide concentrations. Three patients achieved exogenous insulin independence for 7-54 months. [Meaning one person was functionally cured for 4 1/2 years.]

Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22419704
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01341899

Alefacept Finishes Enrolling a phase-II Clinical Trial

This study is also called "T1DAL", which I'm sure is pronounced "tidal".  This trial is being run by the Immune Tolerance Network, and they finished enrolling people in the trial on 30-April-2012.


This drug targets the immune system's T cells, and is already approved for treating "plaque psoriasis" which is an autoimmune disease similar to type-1 diabetes.  It has a good safety profile there. The hope is that by giving it to honeymoon type-1 diabetics, beta cells will be preserved.


Why is finishing enrollment important? For two reasons.  First, because it is now possible to predict when they will finish collecting data.  (This study collects data for 2 years, so they should have it done by May-2014.)  Second, because much of the uncertainty that surrounds clinical trials, is involved with recruiting participants.  It is often unclear how hard it will be to recruite people, and how long it will take.   But at this point, all that uncertainty is behind the researchers.  From now on, it is just gather data, then analize data, and then publish data.  Researchers have a lot more control over those later stages, then over recruiting people in the first place.


Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00965458


Company X Gets Orphan Drug Status for Drug Y

I often see headlines like the one above.  The most recent was "Andromeda Announces FDA Orphan Drug Designation for DiaPep277". I don't report that as news in this blog, because I don't consider it scientific progress.  Orphan Drug is a designation used by the USA and the EU.  Companies with such drugs have the legal right to sell them for a longer period of time without competition.  The idea is that the drugs target rare conditions, and companies could not profitably develop them, if they only got the benefit of "normal" legal protection, because the market would be too small.  So, if the condition is rare enough, then the government says it is an orphan drug, and then the company gets a longer period of time before others can manufacture the drug.  Now, type-1 diabetes is a very common disease (over 1 million people in the US alone, by most estimates).  So a type-1 diabetes drug would not qualify as orphan.  But drugs that only work in the honeymoon phase can get orphan drug status, because only a couple of tens of thousands people are in the honeymoon phase in the US at any time.  I'm not sure that was a result the people who originally wrote the law would have approved, but that is how the law has been implemented.

But in any case: this is good news for the company, because it mean bigger revenues (or longer revenues) if the drug is successful.  But it does not say anything about the chances of success for the drug.  It says more about the disease being treated, than the drug with the status.

Wikipedia: http://en.wikipedia.org/wiki/Orphan_drug

Omni Announces Some Phase-I Results for AAT

AAT is an anti-inflammatory drug, which the body makes naturally, and which is already FDA approved for people who have a rare condition where a person don't make enough of it on their own. This treatment is based on the idea that treating inflammation can cure/prevent/treat type-1 diabetes.

There are several trials currently underway with AAT.    Omni recently announced some information about the first 12 people treated as part of their trial.  This trial is continuing to enroll more people.  This is a intermediate report of progress.  I'm hoping there will be more information published at ADA or EASD, but this is from their press release.  Note that they are reporting on 12 patients (all treated, no untreated comparison group), and that 7 of the patients were in their honeymoon phase, and 5 were not.

The treatment has been very safe and well tolerated by all the study subjects. 

Six months following the initial screening four of the seven [honeymoon] patients showed increased C-peptide levels, whereas most Type 1 diabetics progressively lose their ability to produce endogenous insulin, and, therefore, demonstrate progressively decreasing levels of C-peptide. 

Three of the seven [honeymoon] patients displayed decreased dependence on insulin during the 3-6 month period following the start of their eight week AAT therapy.

My interpretations (opinions) of the results:

• They don't provide any numbers:  no c-peptide numbers and no insulin number.  I've come to believe this is a bad sign.  I hope they publish this data soon.
• For established type-1 diabetics, it looks like AAT had no positive effect at all, in this small sample. 
• For honeymoon type-1 diabetics, Omni is trying to be optimistic, and it does look like the treated group did better in some ways than average untreated people.  However, the reporting is vague, no numbers are provided, few patients were treated, and things are naturally unsettled in the honeymoon phase, that it is very hard to see the data described so far as a successful result.  So I would not get excited about AAT yet. 

Press Release: http://www.omnibiopharma.com/_literature_136822/Omni_Bio_Diabetes_Trial_Data_-_May_30,_2012

A Personal Note

Several months ago my wife and I started looking for a new house.  That takes a lot of time, and actually buying one, even more so.  I'm happy to say that we were successful, and are in the middle of moving from one Silicon Valley town to another.  That is why I have not had the time to publish any blogs for a while.  It now looks like I will move into the new house in mid-June  (wooo-hooo!).  I hope to return to my normal blogging sometime in late July or August.

I know there are more things going on in the world of research aimed at curing type-1 diabetes than I have included in this blog, and I'm sorry it will take a while to get through the backlog.  I'm sure there will be a land side of new information from the upcoming scientific conferences, as well.

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My blog contains a more complete non-conflict of interest statement. 
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/

Possible Cures for Type-1 in the News (late April)

Alefacept Starts a phase-II Clinical Trial
This study is also called "T1DAL", which I'm sure is pronounced "tidal".

This drug targets the immune system's T cells, and is already approved for treating "plaque psoriasis" which is an autoimmune disease similar to type-1 diabetes.  It has a good safety profile there. The hope is that by giving it to honeymoon type-1 diabetics, beta cells will be preserved.


Because this is an ITN trial, there is a long list of sites where you can participate. For the locals: UCSF is the only California location.  They expect enrollment to take 2 years, but (of course) I hope it fills up sooner than that.  The sooner they finish recruiting, the sooner we learn the results.  The trial is for people within 100 days of diagnosis, and requires weekly injections for 12 weeks, followed by 12 weeks "off", followed by another 12 weeks of injections.

Estimated Enrollment:  66

Study Start Date:  March 2011

Estimated Study Completion Date:  August 2014

Estimated Primary Completion Date:  August 2013 (Final data collection date primary outcome)

Web page: http://www.immunetolerance.org/news/2011/04/itn-announces-enrollment-first-participant-t1dal-trial-people-recently-diagnosed-type-1
Recruiting web site: http://www.t1dal.org/
Clinical Trial: http://www.clinicaltrials.gov/ct2/show/study/NCT00965458

Artificial Pancreas Trial Handles Dinner and Night

Hovorka's team at Cambridge University continues to make progress on testing their AP. These most recent results are aimed at showing that their AP can deal with dinner and the night after dinner. They tested with both a simulated "at home" dinner (fewer carbs, earlier in the evening) and an "out" dinner (more carbs, alcohol, and later in the evening).  The study was small (12 people) and "cross over" meaning that half used a pump and half used an AP for the "eat in" dinner, and then they switch (previously pumpers do AP, previous AP use their pumps), and have another "eat in" dinner, and then do again for the "eat out" dinner.  Each person was in the test group once, and in the untreated group once, for each meal scenario.

"For the eating-in scenario, overnight closed loop delivery increased the time plasma glucose levels were in target by a median 15 percent," said Hovorka. For the eating out scenario, the average time good blood sugar control was increased was 28 percent on average. And, when combined, the average increase in blood sugar control was 22 percent, according to the study.

Remember, the goal for FDA approval for something like this is as good control as a pump, so 22% better than a pump is more than good enough.  Now, to get insurance to pay for it, it will need to do better than a pump, but this trial shows that it is.  My reading of the study, is that they did tell the pump the number of carbs eaten at the meal, so this is what the JDRF would call a stage 4 AP.  (A stage 5 AP would not need to be told ahead of time about carbs in food.)  You can read my general background for AP research (including stages) here:
http://cureresearch4type1diabetes.blogspot.com/2009/09/background-for-artifical-pancreas.html

I know there has been some interest in how accurate CGMs really are.  This is what the study found:

The accuracy of the sensor, evaluated as the median relative absolute difference between sensor glucose levels and paired plasma glucose levels divided by plasma glucose levels, was 8.0% (4.5-19.3%) in the eating in scenario and 12.0% (6.8-17.2%) in the eating out scenario.

News coverage: http://www.businessweek.com/lifestyle/content/healthday/651955.html
Full paper: http://www.bmj.com/content/342/bmj.d1855.full   (Thank you BMJ!)

Team Brazil Rolls
In the past, I have blogged about what I call the "Burt" research, which you can read here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Burt
but it was done in Brazil, so maybe that is a better term for it.  This research uses the patient's own hematopoietic stem cells. (remember that)

In any case, it is by far the most successful research aimed at curing honeymoon type-1 diabetics.  Most of the people treated were insulin free for months, many for years.  Some for five years or longer.  These are much better results than anyone else.  But those results came at a cost of safety.  Although no one died or suffered serious side effects, the treatment involves significant risk.  At least one researcher (not part of this team) has estimated that the chance of dying would be "less than 1%" (personal communications with me), but that is way too high for most people to accept.

So the question is, how does this research move forward?  There have been several different answers, as you might expect:

1. Haller's CSGF+ATG studies are trying a similar treatment, but without the most dangerous drug.
2. Snarski is replicating the Brazilian trial, and getting similar results (and no serious side effects so far).
3. Now in this paper: a Chinese group is replicating their work.  University of Naijing (2006) found that of 5 patients treated within 3 months of dx, 4 of them used no injected insulin for a time.  However, of 11 patients treated after 3 months of diagnosis, none became free of injected insulin.  So the good news here is that the replicated the results.  The bad news is that it looks very honeymoon dependent.  In the past, I had hoped that this treatment might also work for established type-1 diabetics, but this trial shows that isn't true.
4. And also in this paper: the original group is trying to use mesenchymal stem cells (a different type of stem cell than used previously.  This protocol is significantly safer than the current one.  The following paragraph from the paper describes the new protocol:

The protocol includes bone marrow biopsy under general anesthesia in first-degree relatives for the collection of mesenchymal cells. These cells are sent to a laboratory to be stimulated to proliferate for a month and are later infused into the patient ...; there is no need for chemotherapy. The patient is hospitalized for 1 day but only as a precaution. After 1 month, the patient receives another infusion. ... Inclusion criteria are age 12 to 35 years, diagnosis of T1DM less than 4 weeks prior to treatment without ketoacidosis and positive serum levels of anti-GAD. So far [in 2008] , two patients have been included in this protocol and, as soon as we have a proper follow-up, the results will be published.

The paper below is an overview written by this research team.  It describes the background for their original research, the results they got, and continue to get, and (new to me) extentions of their work (items 3 and 4 above).

Full paper: http://www.springerlink.com/content/hq7882r31162332t/fulltext.pdf  (Thank you Diabetology & Metabolic Syndrome!)

Another Overview Paper

This is a readable overview paper by Jay S. Skyler and Camillo Ricordi, both very big names in type-1 diabetes research.  The title is "Stopping Type 1 Diabetes: Attempts to Prevent or Cure Type 1 Diabetes in Man".  Thanks to Ellen at CWD for pointing out this paper to me.
http://diabetes.diabetesjournals.org/content/60/1/1.long


Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.
Blog: http://cureresearch4type1diabetes.blogspot.com
To Get as Email Join here: http://groups.google.com/group/type-1-diabetes-clinical-trials-news

Three New Treatments Preparing to enter Phase-II or Phase-I Human Trials

This is a "hat trick" of new drugs preparing to enter phase-II trials for type-1 diabetes.  Each one of these has started the paperwork part of a clinical trial, but none of them have started recruiting patients as yet.  The first and last are similar anti-inflammatory drugs already approved for CAPS, while the middle is a immunosuppressive.

 
Canakinumab (ACZ885) Preparing for a Phase-II Trial
Canakinumab is a human monoclonal antibody targeted at interleukin-1 beta, and was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the US FDA and the EU EMEA in  2009. CAPS is a spectrum of autoinflammatory syndromes, and some researchers believe that inflammation is important to the type-1 diabetes process.  It is being developed by Novartis.

There is no location information in the clinical trials entry, but the responsible party is Dr. Jay S. Skyler, so I would guess Miami, Florida, USA.  The plan is to enroll 108 patients and complete in December 2014.  It is honeymooners only, you must enroll within 100 days of diagnosis.  This drug has not previously been tested on type-1 diabetes, but skips phase-I trials because it is already approved for other diseases.  It is currently in use in about 21 phase-II and phase-III clinical trials for about several different inflammation based diseases, especially Gout, Type-2 Diabetes, and Arthritis. 


clinical trial: http://www.clinicaltrials.gov/ct2/show/NCT00947427
wikipedia: http://en.wikipedia.org/wiki/Canakinumab

Alefacept Preparing for a Phase-I Trial
Alefacept is a genetically engineered immunosuppressive drug sold under the brand name Amevive was approved in 2004 for sale in Canada, the United States, Israel, Switzerland  and Australia. But not in the EU.  It is used to control inflammation  in moderate to severe psoriasis with plaque formation, where it interferes with lymphocyte activation.  Since psoriasis is an autoimmune condition broadly similar to type-1 diabetes, it is quite reasonable to try it.  However, the lack of approval in EU is worth noting; it seems to generally suppress the immune system, which can lead to side effects.  Obviously, the perfect drug would suppress the autoimmune attack on beta cells, without suppressing any other autoimmune attacks.  Usually the EU's EMEA approves new drugs (and especially new devices) more quickly than the US's FDA, but that is not the case here.


This study will be run at Emory University (Atlanta, Georgia, USA) and plans to enroll 45 patients and complete in October 2014.  It is honeymooners only, you must enroll within 6 weeks of diagnosis.  This drug has not previously been tested on type-1 diabetes, but is already approved for other diseases, as described above.  It is currently in use in about 37 phase-II, phase-III, and phase-IV clinical trials (several completed) for several diseases, especially Psoriasis.   This study is done in collaboration with Astellas Pharma US, Inc.

clinical trial: http://www.clinicaltrials.gov/ct2/show/NCT00965458
wikipedia: http://en.wikipedia.org/wiki/Alefacept

Rilonacept Preparing for a Phase-II Trial
This drug is has been available since 2008 to treat CAPS under the name Arcalyst.  It is an interleukin-1 inhibitor.

This study will be run at University of Texas Southwestern Medical Center (Dallas, Texas, USA) and plans to enroll 72 patients and complete in June 2012.  It is ultra-honeymooners only, you must enroll within 2 weeks of diagnosis.  This drug has not previously been tested on type-1 diabetes, but skips phase-I trials because it is already approved for other diseases.  It is currently in use in about 12 phase-II and phase-III clinical trials for about several different inflammation based diseases, especially Gout.


clinical trial: http://www.clinicaltrials.gov/ct2/show/NCT00962026
wikipedia: http://en.wikipedia.org/wiki/Rilonacept (but not much here)

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.
Blog: http://cureresearch4type1diabetes.blogspot.com
Web: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials