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DiabetesCureReadyForHumanTrials

Page history last edited by Joshua Levy 9 years, 4 months ago

 

Warning!  This page is no longer up to date!  If you want this kind of information, please visit my blog:

http://cureresearch4type1diabetes.blogspot.com/

 

Possible Diabetes Cures Ready For Human Trials

 

Last update: 2011-03-23 (All dates are in YYYY-MM-DD format!)

Text marked with ** are things I know I'm going to update.

 

This is my list of possible cures for type-1 diabetes that are either in human trials or almost ready for human trials. I will try to put in every trial that I learn of, that meets the following criteria:

  1. It is a cure for type-1 diabetes, not a treatment for a symptom. (A cure requires blood sugar control, both BG and A1C, without testing and with doctor's visits 4 times a year, or less. Obviously, this is my personal definition of a cure; yours may differ. Any cure must result in an average lifespan close to normal.)
  2. It is either in human trials now, or has been in the recent past, or they have started the paperwork to start a human trial.  (In the past I have accepted when a researcher talked about starting human trials within two years, but no longer: now you need to have started your paperwork.)
  3. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)

In the past I have excluded research specific to the "honeymoon" phase of the disease, but I have now decided to include human trials which focus on the honeymoon phase. Research by Diamyd, Faustman and others has convinced me that a cure for all diabetics may grow out of a cure for "honeymoon" diabeteics.  Blog entry on complete cures growing out of honeymoon only cures.

 

If you know of any trials which are not listed here, please email me to tell me about them joshua2levy@yahoo.com.

 

Notes:

  • I do not control the ads you see on the right!  They usually involve quack ("homeopathetic") cures for type-2 diabetes, and they annoy me, too.

 

  • I generally don't know anything about any of these trials except what you see here, so please don't email me to ask for more info. Instead, research them yourself on the web. (And if you tell me what you find, I'll add it here. :-)
  • Many of the clinical trial descriptions (and other information below) are taken from public documents, which I sometimes rewrite (or rewrite in parts), but sometime use as written.  

 


 

A link to discussion of When Will Treatments Be Ready

If you want to know when these treatments will be ready for use: Understanding the Research Funnel.  There is also FierceBiotech's summary of the FDA approval process.

 

Here is the official FDA definition of phases in these trials: Phases. Also, at least one company uses this scheme: Phase I cures have a 10-30% chance of getting to market, phase II is 30-60%, phase III is 60-80%, and after that the chances rise to 80-90%. Although I do not track animal research in detail, my estimate is that much less than 50% of the treatment which cure mice ever even start a clinical trial.

 

To see more recent updates, visit my blog: http://cureresearch4type1diabetes.blogspot.com/

Old Updates: UpdateMarch2008UpdateMarch2007

 

A link to The Bonyard

 

A link to Studies you can Participate In

 

Recent Changes

  • 2011-03
    • Removed anti-CD3s which have failed in the last 6 months.
  • 2010-08
    • Added Alpha-1 Antitrypsin (AAT), Canakinumab, Alefacept, and Rilonacept (too about to start phase-I trials).

 

A link to more information on HattersleyCure

If you (or your child) was diagnosed with type-1 diabetes before 6 months of age, then you might have a specific varient of type-1 diabetes, for which a cure is being developed, read here: HattersleyCure. This varient is quite different from the more common form of type-1 diabetes, and this cure will not help most type-1 diabetics. If you were diagnosed with type-1 diabetes after you were 1 year old, you do not have this varient.

 

A link to NonCures, a list of things that I don't follow, but people ask about anyway.  Usually with some status, and why I don't cover them.

 

A link to general concepts and background material to help understand possible cures to type-1 diabetes.

 

The List of Possible Cures Being Tested

 

Treatments that have Started Phase-III Trails

 

Diamyd by Diamyd

 

Summary of Current Clinical Trials:  By my count Diamyd now (2010-03) has six different clinical trials going all at once:

  1. They have a classic phase-III clinical trial for honeymoon diabetics which helps preserve insulin production so that patients use less insulin, and maybe no insulin at all. This being done in the US, and being 300+ patients. Clinicaltrial Record
  2. They have a "twin" phase-III clinical trial being done in Europe with another 300+ patients. Clinicaltrial Record
  3. There is a NIDDK phase-II/III clinical trial which is very similar to the studies above.  Clinicatrial Record
  4. They have extended their previous phase-II trial (to continue to run it for several extra years) to look for longer term effects (both good and bad).
  5. They have phase-II clinical trial aimed at both preserving existing insulin production and regrowing new beta cells (a possible non-honymoon cure).  Clinicaltrial Record  However this study has been scalled way back, and is now only going to enroll three people, so it is really a phase-I.  Read my most recent blog on this study.
  6. They have a phase-II clinical trial aimed at LADA diabetics (middle aged people who get type-1 diabetes).  Clinicaltrial Record

And that's not counting the two prevention clinical trials that they are running (in Norway and Sweden).

 

Summary of phase-3 study (Taken directly from Diamyd materials.):

The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within 3 months of diagnosis. In one arm of the study, 102 patients will receive a 20 µg injection of Diamyd® on study days 1 and 30 to confirm earlier Phase II results. In a second arm, 102 patients will receive a 20 µg injection of Diamyd® on days 1 and 30, and then additional doses on days 90 and 270 to investigate the potential long-term beneficial effect of extra doses. In the third arm of the study, 102 patients will receive placebo. Results of the study will be analyzed 15 months after all patients have received their 1st injection. A parallel similar Phase III study is planned to be conducted in Europe

 

Results of Previous Clinical Trials:

Clinical trial record for phase-II.

 

JDRF has helped with the earlier development of this treatment.

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-11-22: 

2009-04-17: They expect to have phase-III results in 2010-Q4.  newspaper article

2008-03-19: Permission to start phase-3 studies in the EU discussion group posting Clinicaltrial Record

2008-03-18: Permission to start phase-3 studies in the US press release  Clinicaltrial Record

2007-05-04: Discussion of why this may work for long time diabetics is here.

2007-03-12: Phase III trials planned to start. http://biotech.idg.se/2.1763/1.98423

Enrollment in each of the approximately 30 sites in the US and Europe will take approximately 9 months. Results will be evaluated after 15 months with the patients then continuing to be followed for an additional 15 months.

2006-08-25: Phase II result presentation on 23rd: looks like they did everything they wanted to do. MyDiamydPhase2Discussion. Next news will be results of Phase II for LADA patents in 2007-06. Or maybe start of Phase III in type-1 before that.

2006-12-15: Meeting with FDA scheduled for January 29, 2007 in Washington DC source

2006-09-19: More data from previous Phase II study: http://www.diamyd.com/docs/PressClip.aspx?PageID=10&LangID=2&ClipID=312&sm=b_b

2005-10-12: Company has requested end of Phase II meeting with FDA to plan Phase III: Source

Clinicaltrails record for the phase-II study

 

Diapep 277  by Andromeda

http://andromedabio.com    Venture Capital Funded, not publicly traded

My Blog Entries on Andromeda

Treatment is also know as hsp60 and Diapep227.

Other companies involved: Teva, Clal, Developgen

 

Summary of Cure (by the company): DiaPep277® is a synthetic peptide made up of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60). The peptide modulates the immune system that leads to type 1 diabetes by diminishing or blocking the destruction of beta cells by the immune system.

 

Summary of Current Clinical Trials:

 DIA-AID 1    Phase-III

Start Date: 2005-09, Enrollment: 457 and Estimated Completion: 2011-12

Last milestone: Fully enrolled by ??**.  Next milestone predicted: Data complete by ??**.

"A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients"

 

DIA-AID 2   Phase-III

Start Date: 2010-05, Enrollment 450, and Estimated Completion 2014-03

Last milestone: Started 2010-05.  Next milestone predicted: Fully enrolled: 2011-11.

It is a confirmatory phase III study. This study will be a global clinical trial which will be conducted in Europe, USA, Israel, and Latin America with approximately 450 patients being recruited at more than 100 clinical study sites.

To be eligible for the study, potential patients should be between 20 to 45 years of age and within 6 months of diagnosis of type 1 diabetes. Furthermore, the study requires a residual beta cell function when fasting of C-peptide ≥ 0.2nmol/L.  Patients will be randomized to 1.0 mg DiaPep277® or placebo with primary endpoint beta cell preservation of function.  Data will be collected for 25 months.

 

901 Extension Phase-III   Is an extension to their phase-II clinical trial where previous patients can be followed for longer periods of time.  

Start Date: 2008-09, Enrollment: 50 and Estimated Completion: 2013-12

Last milestone: Study started 2008-09.  Next milestone predicted: Fully enrolled.

 

Previous Clinical Trials:

Diagram of Older Results (but I"m not sure if these are phase-I or phase-II results)

Corporate page on clinical trial results (with links to many more reports).

A Study on LADA diabetics was terminated.

 

JDRF has helped with the earlier development of this treatment.

 

History:  (For a more newspaper like view of history, visit my blog.)

2008-12: Andromeda make a http://www.pharmacychoice.com/News/article.cfm?Article_ID=231615">press release saying their phase-III experiment, currently underway will last another 2 years (after expanding it to 233 people to get statistical significance that was missing previously).

2008-06-23: Andromeda Biotech Announces Interim Results for DiaPep 227 source: press release, but hold the hype: "The reason is that the interim result does not provide statistically significant results about the effectiveness of DiaPep 277" source: press report

2007-06-14: DiaPep277 is spun off to "Developgen Israel" formerly PEPTOR LTD, a company jointly owned by Developgen and Andromeda.

2007-04-17: "The product is currently in phase III clinical development in a global study being carried out in Europe, South Africa and Israel."

2006-05: DiaPep277® has successfully completed phase II clinical rials for the treatment of type 1 diabetes. DeveloGen has started phase III clinical trials in September 2005. Source

2001-11-23: Phase II completed, phase III to start "next year". Source

 

 

Treatments that have Started Phase-II Trails

 

Abatacept by Orban at Joslin Diabetes Center

My Blog Entries on Orban, My Blog Entries on Abatacept 

 

Summary of Cure: "By using CTLA4-Ig Abatacept close to the onset of T1DM, we hope to arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous insulin production. CTLA4-Ig regulates T cell function but does not deplete T cells. Therefore, its safety profile appears to be better than other immunosuppressive agents." This drug is already approved for use on rheumatoid arthritis (in certain situations), and is currently part of many human trials for several different "self immunity" based diseases such as Psoriasis Vulgaris, Asthma, Scleroderma, Ulcerative Colitis, Lupus, Multiple Sclerosism and Graft or Organ Rejection.

 

Summary of Current Clinical Trials:

NCT00505375  Phase-II  honeymoon only  (** need results for this one **)

 

Unfortunately, there was no phase-I trial targeting type-1 diabetes for this drug, so there is no data on it's effectiveness against type-1 diabetes. Since it was already approved for use in people, they could skip the phase-I trial because the drug's safety was already known. It did prevent diabetes from developing in NOD mice.

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-10-22: http://www.emaxhealth.com/2/23/28695/saving-insulin-producing-cells.html">newspaper article describes the trial and says that one site is fully subscribed

2008-11: Phase-II study has started 108 people enrolled, started 2008-02, expected to end in 2013-06

 

Anakinra at Steno

This record covers two trials, a phase-II trial at Steno and a phase-I trial by Adhikari.

This drug is also known as Kineret.

My blog entries on Kineret

 

Summary of Cure: Anakinra is an Anti-Interleukin-1 drug which is known to target inflammation and is already used for other inflammation related, autoimmune diseases (such as arthritis). 

I have some general comments on anti-inflammatory cures.

 

Summary of Current Research: **

NCT00711503   Phase-II   Honeymoon only.

 

NCT00645840   Phase-I   Honeymoon only.

 

Atorvastatin by Willi

Treatment is also known as Lipitor (yes, the widely used anti-cholesterol medicine).

My Blog Entries on Atorvastatin

 

Summary of Cure: **

 

Summary of Current Clinical Trials:

NCT00529191   Phase-II.  Honeymoon only.

Start Date: 2007-07, Enrollment: 40 and Estimated Completion: 2010-07

Last milestone: Fully enrolled by 2010-02.  Next milestone predicted: Data complete by 2011-02.

This study is Double Blind, Randomized, and Placebo-controlled. Patients are within 8 weeks of dx for type-1 (so honeymooners only). 2/3 of the people will get Atorvastatin (Lipitor) and will be compared against the 1/3 who don't get the drug.

 

Results of previous clinical trials:

There was no phase-I study for this treatment, because they knew the drug was safe, they went straight to phase-II.

 

Comments:I know of one study which gave Atorvastatin (Lipitor) to people with established type-1 diabetes in the hopes it would limit artery damage. It was not successful. However, I don't see that those guys reported A1C, BG, or insulin usage numbers turning the trial:

http://www.freundpublishing.com/Journal_Pediatric_Endocrinology_Metabolism/JPEM22p65.pdf

Of course, the studies are focused on different time frames, honeymoon vs. non-honeymoon so they may well come to different results.

 

Brod at University of Texas-Health Science Center

Phase II trial based on this Phase I trial:   (** need to come back to this one **)

 

Summary of Cure: Brod's theory is that autoimmune diseases, which occur when the body is attacked by its own immune system, are actually an alpha interferon immunodeficiency syndrome.

 

Summary of Current Clinical Trials:

NCT00024518    Phase-II Study, which is complete.

Brod has finished a Phase-II clinical trial of oral interferon alpha, as a possible honeymoon cure of type-1 diabetes, and has published the results. The study involved 128 people, some of whom got 5k units of interferon, others got 30k, and others got none at all; daily doses for one year. After a year, natural insulin production in response to a meal was measured. The experiment was random assignment and double blind.

 

The results were this: The untreated group lost 56% of their insulin production one year after diagnosis. The group treated with 30k lost 46% but the group treated with 5k lost only 29%. So the best-to-worst summary is that the treated group lost about half as much insulin production as the untreated group. This result is very similar to Diamyd's and ToleRx's Phase-II results.

 

Results of previous clinical trials:

NCT00005665    Phase-II.  ** need info ** need to make sure these are not the same study both phase-II **

 

 Phase-I    Abstract of Phase I Trial

In a phase I clinical trial with 10 T1DM patients, 8 of the 10 patients demonstrated a 30% increase of stimulated C-peptide levels for 12 months after initiation of ingested Interferon-alpha (IFN-a) with no discernible chemical or clinical toxicity.

 

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-07-01: Phase II trial results published in Diabetes Care.

2006-04-21: Phase II trial funded.

 

Funded by Diabetes Action

 

Diabecell by Living Cell Technologies

http://www.lct.com.au   Stock Symbol: LCT (Australian Exchange: ASX or AX)   LCT's 2009 Yearly Report

My Blog Entries on LCT

 

Summary of Cure: LCT is developing an encapsulated pig cell cure for type-1 diabetes.

The company describes it this way: "DiabeCell is a porcine pancreatic cell product for the treatment of insulin-dependent diabetes.

The islet cell efficiently secretes insulin, which is defective or absent in patients with type 1 diabetes. The cells are introduced into the abdomen of the patient in [an out patient] procedure under local anaesthesia. The encapsulated DiabeCells do not require the use of immunosuppressant drugs."

 

Summary of Current Clinical Trials:

LCT is currently running two clinical trials, one in Russia (where everyone has been treated, and follow on is continuing), and the other in New Zealand (where only some of the people have started treatment).

 

Russian Trial   Phase-I

This research has already shown that their encapsulated cells can have good effect for short periods of time. The big question they need to answer are these:

1. Will larger doses of encapsulated cells results in less need for injected insulin?

2. How long will the encapsulated cells continue to work?

This trial will directly address question 1. By using higher doses, they will see if they get more generated insulin, and a higher percentage of people who are off insulin entirely. Unfortunately, question 2 can only be answered by time. By following the patients from the Russian trial and from this new trial for a year or two. Although it may be that they'll learn more about duration by starting with a higher dose.

** need references for the published results of this.

 

NCT00940173   Phase-I (first four people)  / Phase-II (second four people)   This is the "New Zealand" study.

Start Date: 2009-07, Estimated Enrollment: 8.  Data Duration 1 years. and Estimated Completion: 2011-01

 

My commentary and opinions:

  • Whenever I blog about LCT, I get asked "how much will it cost?".  And the answer is: I don't know. LCT has not announced it, and it may not be decided as yet.  The whole idea of discussing the price of a treatment which you can not yet buy, for me, is putting the cart before the horse. 

 

Funded mostly by private equity, and JDRF partily funded their current phase-II trial.

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-06-25: LCT gets permission to start a phase-I trial in New Zealand and contunes to update their clinical data but also seems to have stopped their attempt run a phase-II trial in Denver this year.  (need to add links)

2009-02-11: LCT Releases follow up data from their phase-1 trial.  press release

2008-06-06: LCT Expands phase-1 trial already underway press release This includes doubling the the dose, and expanding the number of people enrolled.

2008-02-26: LCT plans a phase-2 trial in the US starting in 2009 press release

2008-02-13: LCT will announce first data from their tiny phase-1 trial on 2008-03-31, but preliminary results look very good! press release

2007-10-30: LCT gets about $6.4 million investment from NaviGroup, as described here: press release

2007-10-22: In progress update from their PhaseI trials in Moscow: Their first two patients after the first injection (of two planned) one dropped insulin requirement by 40% and the other stopped needing insulin entirely. This is a very positive result! Although we do not know how long the effect will last. Details here: Press Release

(Note: in future need to add more discussion to this huge result!)

2007-06-14: First transplant as part of Phase I trials in Moscow. Expected to last 2 years, so results available mid-2009.

2007-05-22: LCT awarded IANZ accreditation for xenotransplantation laboratory press release

2007-05-16: Start Phase I trials in New Zealand on 8 people later in 2007.

2007-03-12: Start Phase Ia trails in Russia in Q2 2007 (transplants completed Q3 2007). Intend to start similar trial in New Zealand in 2007.

http://www.lct.com.au/news/LCT%20Market%20Update%20Mar07.pdf

2007-01-30: Announcement of a "Phase I/IIa" trial in Russia. Press Release with many details or read a newspaper account. Summary:

Trial starts 2007-04, and some results will be available in 6 months.

Trial in Russia with a total of 6 people in 2 groups (very small).

LCT also plants to start a similar trial in New Zealand, with approval "within weeks".

2006-12-18: Approval granted by NZ government to produce xeno product for humans. Hope for part 1 approval by 2006-12-25, and then ethics approval and minister approval are needed to start Phase 1 trials. Source

2006-11-24: Request for Phase I trail start submitted in 2006-08. Hope to start Phase I trails in 2007. Hope to get to market by 2011.

(From: http://www.lctglobal.com/publications/AGM-presentation-Nov06.pdf)

2006-02: Human trials in 2006 or 2007.

 

2006-08-24: application with the New Zealand for Phase I/IIa expected to last about 12 months. No firm start date. http://www.lct.com.au/news/LCT-lodges-application-for-clinical-trial-24-8-06.pdf

 

 

 

 

 

Liraglutide by Madsbad 

Also known as Victoza.

Other companies involved: Novo Nordisk.

My Blog Entries on Liraglutide

 

Summary of Cure: ** add

 

Summary of Current Clinical Trials:

NCT00993720   Phase-II.  

Start date: 2009-09.  Estimated enrollment: 30.  Estimated completion date: 2010-08.

Last milestone: Study started 2009-09.  Next milestone: Enrollment completed: 2010-06.

 

 

 

PROCHYMAL by Osiris Therapeutics

http://www.osiris.com/     NASDAQ Ticker symbol: OSIR

My Blog Entries on Osiris

 

Summary of Cure: Prochymal is an intravenously administered formulation of mesenchymal (adult) stem cells.

 

Summary of Current Clinical Trials:

 

NCT00690066    Phase-II. Fully Enrolled.

Start Date: 2008-06, Estimated Enrollment: 60 and Estimated Completion: 2010-12

The phase-II clinical trial involves who will be followed for 2 years.

 

Comments: This is an adult stem cell formulation, that the US government has poured 100s of millions of dollars into for use as a "medical countermeasure to nuclear terrorism and other radiological emergencies" and Osiris is also trying to productize it for many other diseases. It was in phase III trials for steroid refractory acute Graft vs. Host Disease (GvHD), newly diagnosed acute GvHD, but both of these trials failed to show beneficial effect.  It is also in phase III trials for Crohn's disease, and phase-II for post heart attack healing and chronic obstructive pulmonary disease (COPD), in addition to type-1 diabetes.

 

Unfortunately, there was no phase-I trial targeting type-1 diabetes for this drug, so there is no data on it's effectiveness against type-1 diabetes. Since it was already approved for use in people, they could skip the phase-I trial because the drug's safety was already known.

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-08: Phase-II trial is half enrolled, so JDRF release more money to them.  Press release.

2009-07: News paper article.

2008-12: Still recruiting patients for their phase-II human trial.

2008-07-07: Phase II trial started 2008-06 and scheduled to end 2010-06. This study involves 60 people at 4 sites, and is targeted at new-onset type-1 diabetics.

2008-06-27: newspaper article

 

JDRF is helping to pay for the phase II trial.

 

 

 

Sitagliptin by Garg

Barbara Davis Center in Denver

My Blog Entries on Sitagliptin    Wikipedia on Sitagliptin

 

Summary of Cure: ** need

 

Summary of Current Clinical Trials

NCT00978796   Phase-IV.

Start date: 2009-09.  Estimated enrollment: 20.  Estimated completion date: 2010-05.

Last milestone: Study competed.  Next milestone: Publication of results.

 

 

Thymoglobulin by Gitelman

USF  page

My Blog Entries on Gitelman   My Blog Entries on ATG

Treatment is also called: ATG.

 

Summary of Cure: Give Thymoglobulin during the honeymoon timeframe.  Thymoglobulin® is a mixture of  antibodies and attaches itself to T cells, some of which are responsible for the immune system's attack on beta cells that occurs in type 1 diabetes. Thymoglobulin can change how T cells work, and can eliminate a large proportion of the T cells from the bloodstream temporarily. Treatment of new onset type 1 diabetes with Thymoglobulin is therefore expected to alter the behavior of the T cells to halt their attack, and also reduce T cell numbers, so that new T cells that grow in their place will learn to accept the beta cells, rather than attacking them.

 

Summary of Current Clinical Trials (called START):

NCT00515099   Phase-II.  Honeymoon only.   Main Web Page for the START trial,   ITN page,   

Start Date: 2007-08, Estimated Enrollment: 66.  Data Duration 2-5 years. and Estimated Completion: 2015-06

"Treatment of new onset type 1 diabetes with Thymoglobulin is therefore expected to alter the behavior of the T cells to halt their attack, and also reduce T cell numbers, so that new T cells that grow in their place will learn to accept the beta cells, rather than attacking them." 2/3 of patients will be treated, 1/3 will get placebo.

 

History:  (For a more newspaper like view of history, visit my blog.)

 

The phase II trial is supported by JDRF.

 

 

Xoma 052 by Xoma

http://www.xoma.com  NASDAQ: XOMA

 

Xoma is a publicly traded company which is in the business of developing monoclonal antibodies which are then marketed by much larger companies. They already have a couple of drugs on the market.

 

Summary of Cure: Xoma 052 is a monoclonal antibody which is a broad anti-inflammatory, and works by blocking the IL-1 inflammation pathway.  I have some general comments on anti-inflammatory cures.

 

Summary of Current Clinical Trials:

NCT00998699  Phase-II

Start: 2008-03, Estimated: Enrollment: 240 and Completion: 2012-12

Their current study is placebo controlled and double blind, and the primary end-point is C-peptide levels (so good design). It is being done in Zurich and I'm not sure how many people will be enrolled. Only people who have had type-1 diabetes for 2 years or longer will be enrolled. So this is not a honeymoon study: quite the opposite; honeymoon diabetics are excluded.

 

ClinicalTrial Records for all of Xoma's Trials

 

Other results:

Results on phase-I trial for type-2 diabetics looked very interesting.  A1Cs dropped for everyone in one particular dosing scheme, but will it map to type-1 diabetics?

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-11-18: Phase II trial starts.  Press Release 

 

Treatments that have Started Phase-I Trials

 

ATG and others by Burt at University of Sao Paulo

 

My Blog Entries on Burt

 

Summary of Cure: First the patients underwent high-dose chemotherapy to eliminate the white blood cells that were attacking the pancreas. The process shut down their immune system and stopped further destruction of the twenty to forty percent of their beta cells that remained. Then they were injected with a chemical that freed their own (autologous) stem cells from their bone marrow, which is full of stem cells. These hematopoietic stem cells (bone marrow cells that are precursors of immune T-cells) were filtered out of their blood, treated, and then re-injected into their blood stream in order to re-start a new and better immune system.

 

Summary of Current Clinical Trials:

 

NCT00315133   Phase-I   All patients treated; follow ups continuing.

News Article

Full 2007 paper

Full 2008 paper

 

Except for the first and last patients, all the patients in this were insulin free for at least 5 months. Most for longer. Much less insulin was used by the people treated in this way, then expected without treatment.

 

Comments: One of the questions that I'm occasionally asked is this: when will there be a follow up to Burt's Brazilian research? When will there be a Burt, phase-II? This is a natural question, because Burt has -- by far -- the best results of any one. Many patients on that trial went years without using external insulin. No other study comes close. So an obvious question is: how do you move forward with that research.

 

Burt's research is the opposite of most. Most researchers use the smallest possible doses during phase-I. Phase-I is targeted at safety, so they use small doses to assure safety even at the expense of effectiveness. So for most studies, for phase-II studies, they move forward by raising the dose to try to make a safe treatment a more effective one. But Burt's research is the opposite. The effectiveness is the strongest yet, but there are real questions about safety. So you would NOT follow it up by raising the doses!

 

One way to follow up Burt's relative success, is by turning down the dose. Trade off a little effectiveness for added safety. Oversimplified a little: Burt's research involves using three drugs (ATG, GCSF, and cyclophosphamide), and reinjecting the patient's own precursor bone marrow cells (previously removed). Dosing with just ATG can be viewed as a "kinder, gentler" Burt. Especially since the cyclophosphamide is the most risky drug of the bunch.

 

History:

 

 

BCG by Faustman at BGH

Faustman's Lab Web Site

My blog entries on Faustman's Research

 

 

Summary of Cure: 

Dr. Faustman's path to cure type-1 diabetes goes like this:

  1. Give BCG, which causes the body to make TNF
  2. TNF then kills T-cells, but it is more likely to kill defective T-Cells, than good ones. Therefore, the person ends up with far fewer bad T-cells, and the ratio of good T-cells to bad ones goes up. Since these bad T-cells are what attack the insulin producing beta-cells, fewer cells are attacked.
  3. Give a "second compound" which will cause the body to stop making bad T-cells.
  4. Finally the body naturally regrows beta cells, so insulin production is restored.

Her current phase-I experiment is aimed at steps 1 and 2.

 

Summary of Current Clinical Trials: **

NCT00607230   Phase-I  Clinical trial is complete; waiting for results to be published.

In 2010-02 Dr. Faustman announced that the clinical trial was complete, but not when the results would be published.  Prior to that, her lab newsletter had said that the results would be published in "early 2010".  As of 2010-04, they have not been published.

 

Comments:

Dr. Faustman's work has generated a lot of discussion over the years.  Here are a few web pages well worth reading:

The History of Faustman's Work

Discussion from the Joslin Diabetes Center

 

 

Some old comments on Faustman's research.

 

History:  (For a more newspaper like view of history, visit my blog.)

2008-12: The new Faustman Lab web page now says that the current phase-I trial will last until "January 2010".

2008-03-14: Phase-1 study has started to test half of the complete solution. However, this is not a test of a cure for type-1: only half a cure. clinicaltrials.gov record press release

2007-08: Human trials to start sometime in 2008. official update

2006-08: Human trials to start "Fall 2008" although non-human parts will start in 2007.

2006-05: Money to be released before 2006-08, but there is pre-clinical work to be done, so human trials will start after that.

2006-03: Clinical trials to start "soon".

 

Funded until end of 2008 by "Join Lee Now".  Also funded by **, but now mostly funded by direct donations.

 

 

BHT 3021 by Bayhill Theraputics

http://www.bayhilltherapeutics.com  not publicly traded

My Blog Entries on Bayhill

Other companies involved: Genetech

 

Summary of Cure: BHT-3021 is a plasmid encoding proinsulin designed to tolerize the immune system to proinsulin, thereby turning off the self directed immune attack. So it is designed to teach the body to stop attacking it's own beta cells.

 

Phase-1 study currently underway, started 2006-10. Orginally supposed to end 2008-12, but not clear if that is the data gathering end, or the data analysis end. Some data has been published.  company's summary to date

Note that this clinical trial is not limited to "honeymoon" diabetics.

 2008 results from phase-I: http://www.bayhilltx.com/BHT-3021_Gottlieb_EASD_2008_poster.pdf 

 

 

My Blog Entries on Bayhill

 

Summary of Current Clinical Trials:

 

NCT00453375

  Phase-I  Established Diabetics Accepted  

Comments: Although developed by Bayhill Theraputics, this drug has been purchased by Genetech.

 

Blog entry by someone who was in the Phase-I trial (but he got the placebo):

http://dandtheguy.com/2009/09/14/a-cure-for-diabetes-may-be-closer-than-ever/

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-06-10: Drug purchased by Genetech press release

2009-06-05: Interrum results from the phase-I trial published at ADA.  abstract 

2009-10: JDRF and Bayhill begin to collaborate on BHT-3021

2008-01-09: company is looking for an IPO press release

 

2009

 

 

Diazoxide by Grill at University Hospital of Trondheim

Wikipedia entry for Diazoxide (not much there).  

Summary of Cure: This is a "stop the immune attack on beta cells" type treatment.

 

Summary of Current Clinical Trials:

NCT00131755   Phase-II (technically Phase-IV)   Complete and published results in 2009-12.  Honeymoon only

This is a double blinded placebo controlled study, with 35 participants with newly diagnosed type 1 diabetes are randomised into either placebo or Diazoxide for 6 months. The patients will be followed up after intervention for at least 12 months.

Summary of 6 month follow on results abstract:

Diazoxide treatment reduced A1C from 8.6% at baseline to 6.0% at 6 months and 6.5% at 12 months. Corresponding A1C value in the placebo arm were 8.3, 7.3, and 7.5% (P < 0.05 for stronger reduction in the diazoxide group). Fasting and stimulated C-peptide decreased during 12 months similarly in both arms (mean −0.30 and −0.18 nmol/l in the diazoxide arm and −0.08 and −0.09 nmol/l in the placebo arm). The proportion of Tregs was similar in both arms and remained stable during intervention but was significantly lower compared with nondiabetic subjects.

 

History:  (For a more newspaper like view of history, visit my blog.)

 

Etanercept by Amgen

Also known as ENBREL.

My Blog Entries on Etanercept   Wikipedia entry on Etanercept

 

Summary of Cure: Etanercept is US FDA approved for several self-immunity related conditions including Rheumatoid Arthritis and Psoriasis, so it seems pretty straight forward to try it on type-1 diabetes.

 

Summary of Current Clinical Trials:

NCT00730392   Phase-II. This trial is complete, and the results published in 2009-04:   Abstract  

The results were solidly good, after 24 weeks:

      • HbA1c was lower in the etanercept (5.91 +/- 0.5%) compared to placebo group (6.98 +/- 1.2%)
      • The percent change in c-peptide AUC showed a 39% increase in the etanercept group and a 20% decrease in the placebo group
      • Insulin dose decreased 18% in the etanercept group compared to 23% increase in the placebo group

So the result in plain English is that the treated patients had, on average, A1C measures 1 lower than the non-treated group. They were generating about 60% more of their own insulin (as measured by c-peptide), and used about 40% less insulin. Overall, very nice results for a phase-I trial.

 

Summary of previous trials: Although Etanercept has not been previously tested on type-1 diabetes, it has been extensively used for other autoimmune diseases and as part of transplant protocols.  It has been used in about 240 different clinical trials.

 

Comments: I did find two interesting papers that reported that people who had type-2 diabetes and who were treated with Etanercept for rheumatoid arthritis had large drops in their BG numbers. How that maps to people with established type-1 diabetes, I'm not sure.

 

Safety Issues: Although this drug is approved by the US FDA different people may well have different opinions about it's safety. It does carry a black-box warning due to higher rates of infection. (Black-box warnings are the strongest warnings that the US FDA requires on prescription medicines to warn people of potential dangers.)

 

 

IBC-VS01 by Orban at Joslin Diabetes Center

My Blog Entries on Orban

 

Summary of Cure: This adjuvant enhanced autoantigen vaccine is a novel approach in human diabetes. It is aimed to stop or slow down the ongoing autoimmunity against pancreatic beta cells at the clinical onset of the disease by immune modulation.

Clinical Trials Record

ITN Clinical Study Description

 

Patent Info

 

Summary of Current Clinical Trials

 

Abstract of results

Mixed meal stimulated C-peptide responses, measured every 6 months, showed no statistical differences between arms. All patients vaccinated with the autoantigen, but none who received placebo, developed robust insulin-specific humoral and T cell responses. Up to two years following the single injection, in peripheral blood from subjects in the experimental arm, but not the control arm, insulin B-chain-specific CD4+ T cells could be isolated and cloned that showed phenotypic and functional characteristics of regulatory T cells. The induction of a lasting, robust immune response generating autoantigen-specific regulatory T cells provides strong justification for further testing of this therapy in type 1 diabetes.

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-02-28:    abstract

2009-02-05: study is complete and they expect that results will be published in the coming months also a follow up study is in the early planning stages (per comm Jeff Matthews)

2007-04-02: Last update to client trial records.

2003-03: Phase-1 trial starts, planned to last two years.

 

 

Lisofylline by DiaKine

My Blog Entries on DiaKine 

 

Summary of Cure: Lisofylline is an anti-inflammatory drug that (in NOD mice) has prevented type-1 diabetes and (when given with exendin-4) cured existing type-1 diabetes.  I have some general comments on anti-inflammatory cures.

 

Summary of Current Clinical Trials:

NCT00896077   Phase-I.  This trial is designed to ensure that Lisofylline injected under the skin reacts similarly to when injected into a vein.

Start Date: 2009-05, Estimated Enrollment: 8.  Data Duration 2 days?. and Estimated Completion: 2009-12

Last milestone: Start of phase-I: 2009-05.  Next expected milestone: ??

And their official press release is here (and is better than most)

 

 

NI-0401 by NovImmune

 

Pioglitazone by Wilson at Stony Brook

clinicaltrials.gov recordhttp://www.clinicalt…ct2/show/NCT00545857

 

Summary of Cure: This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus. Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes.

 

Summary of Current Clinical Trials:

NCT00545857    Phase-I   Honeymoon Only.

Start Date: 2002-06, Estimated Enrollment: 15 and Estimated Completion: 2012-06

 

History:  (For a more newspaper like view of history, visit my blog.)

 

 

Proleukin and Rapamune by Greenbaum

My Blog Entries on Greenbaum

 

Summary of Cure: The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes progression.

 

Summary of Current Clinical Trials:

NCT00525889

The phase-I, 10 person trial started in 2007-08 and is expected to finish 2012-09

This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months.

 

History:  (For a more newspaper like view of history, visit my blog.)

2008-11: Phase-I trial is still recruiting.

 

 

Trucco at Children’s Hospital of Pittsburgh

 

Summary of Cure: "Researchers then combine the dendritic cells with specific blockers of molecules, known as CD40, CD80 and CD86, all of which can be synthesized in a laboratory. This treatment strategy was found to inhibit the interaction and destructive effect of T cells on the insulin-producing beta cells of the pancreas, a process that is known to be a critical part of how diabetes occurs." http://www.chp.edu/pressroom/newsrelease264.php

 

Summary of Current Clinical Trials:

This is a non-honeymoon clinical trial, involving 15 people.

 

Clinical Trails

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-08-24: Nice newspaper article on the Phase-I study, but no new news.

2008-11-01: Phase I started 2007-03, scheduled to end 2010-05 (publication about 2011-05).

2008-08-25: Phase I scheduled to finish end of 2007, Phase II to start 2008. See this news article

2008-04-28: Phase I started 2007-03, and is expected to end 2008-05. This trial will use 15 people for 1 year.

2006-11-28: Phase I start is now planned for 2007-01.

2006-03-27: Phase one trials to start "this spring" with 15 people. (Status seems unchanged to 2006-08)

 

 

Umbilical Cord Blood Infusion by Haller and Schatz at University of Florida

 

Summary of Cure:  Cord blood, which was previously "banked" at birth, will be infused into the children in an attempt to regenerate pancreatic islet insulin-producing beta cells and improve blood glucose control.

 

Summary of Current Clinical Trials:

NCT00305344

"23 children > 1 year of age with T1D and stored umbilical cord blood are being be recruited. The cord blood will be infused into the children in the GCRC in an attempt to regenerate pancreatic islet insulin-producing beta cells and improve blood glucose control."

 

History:  (For a more newspaper like view of history, visit my blog.)

As of 2009-01: The study has finished recruiting participants. Expected end date is 2010-07

As of 2008-04: This study is currently recruiting participants. Expected end date is 2009-07

Study started: 2005-04

 

This study is sponsored by JDRF.

 

 

Treatments that are Preparing for Phase-1 Trials

 

Alefacept

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

 

 

Canakinumab

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

 

IKDRC

I need to find out more about this research:

newspaper article

http://forums.about.com/n/pfx/forum.aspx?msg=7537&nav=messages&webtag=ab-diabetes

 

 

Bristol Vaccine by Peakman at King's Collage

This entry needs a major update (as of 2009-01-12).

 

Summary of Cure: The first-ever diabetes vaccine trial using an insulin peptide began in the United Kingdom, headed by JDRF-funded researcher Mark Peakman, M.D., Ph.D., at King’s College, London, and Colin Dayan, M.D., Ph.D., at Bristol University, UK The vaccine, which contains an insulin peptide, is aimed at training the immune system to tolerate islet cells rather than attack them, a strategy that has proven effective in preclinical studies.

 

This research is based on the idea of using a modified protein to teach the body's immune system to not attack it's own beta cells. The phase-I clinical trial gave some people no protein, some a little protein, and some a lot. The patients were all people with established type-1 diabetes.

 

History:  (For a more newspaper like view of history, visit my blog.)

2009-03-15: Results are in from the phase-I clinical trial, and you can read the abstractMy comments are on my blog, and there are JDRF comments which describe this trial as well.

2005-10-12: http://www.kcl.ac.uk/business/news/year2005-6/avidexlicense

2004-12-13: Testing on 72 people to see if it is safe. (Equiv. to FDA phase-1 trials.)

Quote from Peakman: "These trials take some years to complete, so it may be five to 10 years before we see real progress."

http://news.bbc.co.uk/1/hi/health/4091399.stm http://news.scotsman.com/health.cfm?id=1423542004

 

Rilonacept

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)

 

Investing in the Cure

 

Here is a list of publicly traded companies listed above, that are working on a cure for diabetes. You can buy stock in these companies:

 

Add in Future

 

Implanted pump:

 

Other Lists of Clinical Trials

 

Futures

 

This section is for companies that might have human trials in the future, they are not planning them now, however. It is more to remind me to check up on them, so I have the company's web site, and the date I last checked on them:

  

 

Keeping track of these for personal reasons:

 

 

Data Sources:

 

DIA-AID 1

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