Possible Diabetes Cures Ready For Human Trials

Last update: 2008-05-13 (All dates are in YYYY-MM-DD format!)

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 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 past, or is expected to be within the next two years.
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.

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

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

Note Also: 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. :-)

  1. Possible Diabetes Cures Ready For Human Trials
  2. Summary of Status
  3. Recent Changes
    1. 2008-05
    2. 2008-04
    3. 2008-03
  4. The List of Possible Cures Being Tested
  5. Treatments that have Completed Phase-2 Trails
    1. Diamyd (DiamydT or GAD65)
    2. Develogen "Diapep 277"
  6. Treatments that have Started Phase-2 Trails
    1. Macrogenics
    2. Tolerrx (TRX4 or ChAglyCD3)
    3. Transition Therapeutics E1-I.N.T. (or EGF/gastrin)
    4. Transition Therapeutics GLP1-I.N.T.
  7. Treatments that have Started Phase-1 Trials
    1. (Pescovitz: Rituximab)
    2. Stony Brook (Wilson: Pioglitazone)
    3. MMF/DZG
    4. Thymoglobulin / ATG ()
    5. University of Florida (Umbilical Cord Blood Infusion) Haller and Schatz
    6. Living Cell Technologies (Diabecell)
    7. Bayhill Theraputics (BHT 3021)
    8. Children’s Hospital of Pittsburgh (Trucco)
    9. Joslin Diabetes Center (Orban): IBC-VS01
    10. Swedish Study
    11. University of Sao Paulo (Burt)
    12. University of Texas-Health Science Center (Brod)
    13. University of Florida (Haller/Schatz)
  8. Treatments that are Preparing for Phase-1 Trials
    1. LIAI Matthias von Herrath (anti-CD3 antibody and proinsulin peptide)
    2. Cambridge University (Hovorka)
    3. Montpellier Medical School (Renard's Artificial Pancreas)
    4. Reneuron (was Amcyte)
    5. Novocell
    6. Microislet
    7. University Hospital of Trondheim (Grill: Diazoxide)
    8. MMF/DZB(Skyler)
    9. BGH / Harvard (Nathan/Faustman)
    10. Sernova (White)
    11. IKDRC
    12. INGAP
    13. King's/Bristol Vaccine
    14. Alba Therapeutics
    15. Cerco Medical, Inc
  9. The Boneyard: Cures that have failed in humans
    1. Anti CD52 drug
    2. Federico Gomez Children's Hospital (Rafael A Valdés-González)
  10. Investing in the Cure
  11. Add in Future
  12. Futures

Each possible cure is named after the institution where the work is done.
I have also include the main researcher's names (where possible).

If you want to know when these treatments will be ready for use: WhenWillTreatmentsBeReady.

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%.

Updates:

Summary of Status

Started Phase III: Diamyd, DeveloGen: DiaPep 277
Completed Phase II: TolerRx, CBCTD
Some results from ongoing Phase II: Transition Therapeutics: E1-I.N.T.
In Phase II: MacroGenics, University of Texas-Health Science Center (Brod): IFN-a, Kinexum, Thymoglobulin
Completed Phase I:
Some results from Phase I: LCT
In Phase I: Federico Gomez Children's Hospital, Montpellier Medical School, ReNuron (was AmCyte), NovoCell, King's/Bristol, Univ. of Florida, University of Sao Paulo (Burt), Swedish Study, Bayhill Theraputics: BHT 3021, Joslin (Orban): IBC-VS01
Planning for Phase I: all the rest
(MGM/Faustman is in phase-1 trials, but not for a type-1 diabetes cure. They are gathering data to see if they can put together a cure, but they have not started testing a cure as yet.)

Recent Changes

2008-05

  • Update to Seranova

2008-04

  • Moved many studies from the "Honeymoon" section to the main section.
  • TolerRX to phase-3 by mid-2008?
  • Added MMF/DZB study

2008-03

  • Investing in Eli Lily
  • Sernova
  • INGAP / Kinexum
  • MGM (Faustman)
  • Diamyd
  • LCT
  • New study: Bayhill Theraputics
  • Alba
  • Joslin (Orban): IBC-VS01
  • Thymoglobulin

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.

The List of Possible Cures Being Tested

Treatments that have Completed Phase-2 Trails

Diamyd (DiamydT or GAD65)

http://www.diamyd.com/
Stock Symbol: DMYDY (US OTC Exchange)
Its lead drug candidate, Diamyd™, is designed to reduce the need of insulin injections and prevent the destruction of beta cells. Furthermore, it may allow for regeneration of beta cells in a non-autoimmune environment, thus setting the stage for a cure of the disease. JDRF has helped with the development of this treatment.
Diamyd Blog

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

2008-03-19: Permission to start phase-3 studies in the EU discussion group posting
2008-03-18: Permission to start phase-3 studies in the US press release
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

Develogen "Diapep 277"

http://www.develogen.com/en/index.php
Venture Capital Funded, not publicly traded
Aventis was involved in this, but I don't think it is any more.
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-2 Trails

Macrogenics

Not publicly traded www.macrogenics.com.
This is an anti-CD3 technique that directly competes with TolerRx.
Has ophan drug status for hOKT3-gamma-1 (Ala-Ala).
clinicaltrail.gov record for Protégé
Estimated Enrollment: 530
Study Start Date: 2006-10
Estimated Study Completion Date: 2011-03
Status on 2008-04: This study is currently recruiting participants.
clinicaltrial.gov record for ?AbAte?
Estimated Enrollment: 60
Study Start Date: 2006-09
Estimated Study Completion Date: 2009-06
Status on 2008-04: This study is currently recruiting participants.
Related studies: abstract
personal testimonial

2007-10-22: Macrogenics signs a deal with Eli Lilly so Lilly will acquire the exclusive rights to teplizumab (MGA031), a humanized anti-CD3 monoclonal antibody. news article. This is a big deal, and suggests that Lilly thinks this treatment is going to be big in the future.
2007-08-15: MacroGenics is currently running three clinical trials into possible cures:

  • Protege: Phase 2/3, 500+ person study. Honeymooners only, of two doses, 6 months apart. This study involves 100 centers in 10 different countries.
    Start: 2006-10 Duration of Data Gathering: 2 years Status: currently recruiting patients.
  • AbATE: Phase 2. 80+ people. Honeymooners only, of two does, one year apart.
    Start: 2005-09 Duration of Data Gathering: 2 years Status: currently recruiting patients.
  • Delay: Phase 2. Honeymooners only.
    Start: 2006-09 Duration of Data Gathering: 1 year Status: currently recruiting patients.


2007-01-03: JDRF Provides MacroGenics with $2 Million in Funding for Phase II/III Clinical Trial. press release As of this date the study is still accepting new people. Goal is 530 people! Study will last at least 2 years after the last person is recruited.
2006-10-10: "MacroGenics anticipates initiating a Phase 2/3 trial to study MGA031 in patients with recent-onset T1DM in the fourth quarter of 2006" ClinicalTrials Description says it started in 2006-10, but no word on how long it should last.
2006-09-25: "By the end of the year, MacroGenics will begin Phase III trials of a drug to prevent juvenile diabetes - just a year after it bought the antibody technology." http://www.islet.org/forum/messages/44878.htm "Phase III trials are expected to end in 2009."

Tolerrx (TRX4 or ChAglyCD3)

Not publicly traded www.tolerrx.com.
This is an anti-CD3 technique that directly competes with !MacroGenics.
More information here: http://www.tolerrx.com/pipeline-trx4.php
Completed Phase I and II.

2008-04-08: Phase-2 trial is completed (need ref). Plan is to start phase-3 trail in mid-2008. press release
2007-05-24: Recruiting for a Phase II trail. notice (Must be 18-60 years old.)
2007-05-24: "Hope for Phase 3 trial start by end of 2007, but that doesn't match with the note above, that they are recruiting for a phase 2 trail to start in 2007.
2006-09-25: Hopes for phase 3 trial by end of the year.
2005-06-23: Results of a Phase II trial published New England Journal of Medicine. Source Abstract of Article
"The study was conducted on eighty patients with type 1 diabetes enrolled in Belgium and in Munich (Germany). Patients who received a six-day course of antibody treatment immediately after diagnosis, maintained, over the 18 month follow-up period, a higher insulin production, ie residual beta cell function, than patients who received a placebo. They were found to need lower doses of injected insulin to maintain blood glucose control. This benefit was primarily seen in patients who presented with a less pronounced loss in insulin production at diagnosis. Side effects were minor and short-lived including flu and mononucleosis-like symptoms."

Transition Therapeutics E1-I.N.T. (or EGF/gastrin)

http://www.jdrf.org/index.cfm?page_id=103347 http://www.transitiontherapeutics.com/
Stock Symbol: TTH (Toronto Exchange: TSX)
I.N.T. is a combination therapy of a selective growth factor and gastrin that can regenerate the body's own insulin-producing cells (islet beta cells in the pancreas). This is a "short course" of drug therapy. This research is partly funded by JDRF.

ClinicalTrial Web Site

2007-03-12: Some results from Phase IIa: "In the type 1 diabetes study, 6 of 11 (54%) patients responded to
E1-I.N.T.(TM) therapy, either by decreasing their average daily insulin usage
by more than 20% or reducing their HbA1c levels by 1.2 to 2%. There were no
responders among the placebo group."
http://www.islet.org/forum/messages/47373.htm http://www.pipelinereview.com/joomla/content/view/10223/101/ http://www.jdrf.org/index.cfm?page_id=106725

2006-04-25: Phase 1 trials 80% enrolled. (Phase 1 trials for type-2s completed!)
2006-05-31: Phase 1 trials fully enrolled, some nice data from early enrollers, also "data from all patients enrolled in the type I diabetes clinical trial is expected in Q4 2006"
http://www.transitiontherapeutics.com/news/index.php?cp=0&cm=5&news_id=156&nc=1&news_year=2006

Transition Therapeutics GLP1-I.N.T.

http://www.islet.org/forum/messages/44263.htm http://www.transitiontherapeutics.com/
(other details above)

2007-03-13: Early Phase IIa results: most used 20% or more less insulin after a 1 month treatment.
2006-09-14: JDRF has funded this advance this into Phase 2 trials.
2006-07-18: Transition aims to begin a Phase 1 clinical study by year-end.

Treatments that have Started Phase-1 Trials

(Pescovitz: Rituximab)

clinicaltrials.gov record

Stony Brook (Wilson: Pioglitazone)

clinicaltrials.gov record
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.

This record was updated 2007-10-16
But there is no start date, end date or trial size listed.

MMF/DZG

This is a "give drugs quickly during the honeymoon period, and save some beta cells" type treatment.

Full Protocol Description

2004-07: Phase-1 study starts. 180 people divided into three groups: MMF, MMF and DZB and neither MMF or DZB. Expected to last four years.

Thymoglobulin / ATG ()

This is a "give drugs quickly during the honeymoon period, and save some beta cells" type treatment.
clinicaltrials.gov record
USF  page
ITN page
"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."

2008-03: A phase-2 trial is about to start recruiting. It will have about 66 people (2/3 treated, 1/3 placebo), and last 2 years.

University of Florida (Umbilical Cord Blood Infusion) Haller and Schatz

clinicaltrails.gov record
"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."

This study is sponsored by JDRF.

Study started: 2005-05
As of 2008-04: This study is currently recruiting participants.
Study expected to end: 2009-07

Living Cell Technologies (Diabecell)

http://www.lct.com.au/
Stock Symbol: LCT (Australian Exchange: ASX or AX)
"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 a ten minute procedure under local anaesthesia. The encapsulated DiabeCells do not require the use of immunosuppressant drugs." As far as I know this company has never asked for funding or support from any non-profit.

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

Bayhill Theraputics (BHT 3021)

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. In any case, no data has yet been published.

I need to do more research on this:
clinical trial record

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

Children’s Hospital of Pittsburgh (Trucco)

http://www.chp.edu/pressroom/newsrelease264.php
Dr. Trucco
"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."
Clinical Trails

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)

Joslin Diabetes Center (Orban): IBC-VS01

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

2007-04-02: Last update to client trial records.
2003-03: Phase-1 trial starts, planned to last two years.

Swedish Study

I need to do much more research on this announcement:
2007-07-24: newspaper article

University of Sao Paulo (Burt)

autologous nonmyeloablative hematopoietic stem cell transplantation

Clinical Trial Record
News Article
Full paper

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.

Need to put in more data.

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.

University of Texas-Health Science Center (Brod)

Phase II trial based on this 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.
Funded by Diabetes Action
Ingested Interferon-alpha in type 1 Diabetes
2006-04-21: Phase II trial funded.
Report on Phase I Trial

University of Florida (Haller/Schatz)

"Our goal is to transfuse autologous umbilical cord blood into 10 children with T1D in an attempt to regenerate pancreatic islet insulin-producing beta cells and improve blood glucose control."
Started 2005-4
Expected completion 2009-10
Phase I trial. Funded by JDRF

More info: http://clinicaltrials.gov/ct/show/NCT00305344

Treatments that are Preparing for Phase-1 Trials

LIAI Matthias von Herrath (anti-CD3 antibody and proinsulin peptide)

Low-dose oral antibody called anti-CD3, which works systemically to prevent the destruction of beta cells. Also a nasally administered pro-insulin peptide. This protein acts like a vaccine, working locally to protect the beta cells from being destroyed.

2006-04-10: "The researchers hope to begin testing the combination therapy in human clinical trials later this year." Source

Cambridge University (Hovorka)

This is a classic closed loop system, but not inplanted.
Funded by JDRF.

2006-11-15: Phase I trial to start 2007-1

Montpellier Medical School (Renard's Artificial Pancreas)

2005-01-31: Seems to have gone through Phase I and II testing in France, but maybe not ready for the mass market? Not sure the current status.

Reneuron (was Amcyte)

http://www.reneuron.com/news__events/news/document_138_237.php
http://amcyte.com/clinical_trials.htm http://amcyte.com/PDF_files/Clinical%20Trial%20Brochure.pdf
London AIM market under the symbol RENE.L

“Prospective Phase I/II Safety Study of Encapsulated Isolated Primary Human Pancreatic Islet Transplantation with Low Dose Short Term Immune Suppression in Patients with Type I Diabetes Mellitus”

2007-08-14: Amcyte purchased by ReNeuron for $4 million
2006-05-09: Phase 1 trail started.
2005-02-22: First transplant as part of this trial.
2003-10-30: Phase I/II trial started.

Novocell

http://www.novocell.com/clinical_trials.htm
This company is privately funded.
Novocell is currently in a Phase I/II study to determine the safety and efficacy of human pancreatic islets encapsulated with polyethylene glycol (PEG) and implanted into patients with Type I diabetes... The islet cells used in this study are isolated from pancreata procured from human cadaver donors who meet a specific human donor profile.
ClinicalTrial Web Site

2006-04-19: In Phase 1 trails.
2006-05-31: JDRF is helping to fund this work
2006-06-12: Poster session results are that the treatment is safe (Phase I), no news yet on effectiveness (Phase II). Early people got small doses.

Gov Summary of Trial

Microislet

http://www.microislet.com/
MII on the AMEX exchange
MicroIslet has licensed several technologies from Duke University Medical Center developed over the last decade for the isolation, culture, storage and encapsulation of insulin-producing porcine islet cells.

2006-12-14: The Company currently plans to file an Investigational New Drug (IND) application in Q3 2007. Source
2006-09-06: Some announcemaent is planned for 2006-09-21, but I don't know what.
2006-08: Six month primate results to be reported in 2006-12 at scientific meeting.
2006-05: Plan to start phase I trials in 2007

University Hospital of Trondheim (Grill: Diazoxide)

This is a "stop the immune attack on beta cells" type treatment.
clinicaltrials.gov record

Phase-1 study started: 2004-03 and is expected to end 2008-06. Study includes about 35 people, all in the honeymoon phase. This study started 2005-02 and is expected to end in 2008-06. (Note that this study is officially a Phase-IV study because the drug has been used to treat other problems, so it's safety profile is well known. I consider it phase-1 for the purpose of treating type-1 diabetes.

2008-04-01: This study is ongoing, but not recruiting participants.

MMF/DZB(Skyler)

This is a "stop the immune attack on beta cells" type treatment.

Phase-1 study started: 2004-03 and is expected to end 2008-06. Study includes about 100 people, all in the honeymoon phase. Study tests MMF alone, DZB alone, and MMF and DZB together. This research is funded by JDRF amoung others.

ClinicalTrails.gov record

BGH / Harvard (Nathan/Faustman)

http://www.joslin.org/1083_3312.asp
Dr. Faustman on the research side, Dr. Nathan on the clinical trials.
Combination of "short course" drugs. Used to involve spleen cells, but that part did not pan out.
Funded by "Join Lee Now"
My comments on Faustman's research.

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".

Sernova (White)

http://www.sernovacorp.com
Publicly traded in Canada: TSX-V: SVA ("penny stock")

2008-05-13: need one big-animal trial prior to human trials. Plan to start that in about 6 months, and it will take about 18 months. So earliest human trials in 2 years. press release
2008-03-18: IND meeting with FDA scheduled for 2008-04-25 press release
2007-08: Now plans an IND meeting with the FDA in 2008, followed by a Phase I trial.
2007-02-15: "Sernova anticipates having these studies completed by the summer of this year, leading to an Investigational New Drug ("IND") filing later in the year."
2007-01-10: Based on their "Fall 2006" presentation, they hope to start phase I trails on an aggressive schedule, in Q4 2007.

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

INGAP

(I'm still trying to organize this one.)
Kinexum Metabolic's INGAP page

http://blogs.healthcentral.com/diabetes/david-mendosa/the-ingap-revival-2006-05-30/

2008-03-18: Plans to start a phase-2 trial "planned to start later this year -- with McGill University Hospital Centre slated to be a trial center" press release
2006-09: Kinexum Metabolics "expect a study to begin in first quarter 07--and possibly before". Note that the http://www.kinexum.com web page refers to a related company, but not Metabolics specifically.
2006-08: But some people still think it is a good idea:
http://www.diabetesincontrol.com/modules.php?name=News&file=article&sid=1743
2006-02: Phase 2 trial (200 people, 3 months) appearently failed to find a theripudic effect.

Here is the old ClinicalTrial Web Site.

King's/Bristol Vaccine

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

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."

Alba Therapeutics

These guys think that diabetes is related to "leaky gut". They have a treatment, called AT-1001 which is supposed to fix leaky gut, and they are in phase-2 testing for Crohn's Disease. They also want to test it for type-1, but it is a secondary goal.
2007-09-05: Alba has announced that they will start clinical trials in 2008.press release
http://www.islet.org/forum/messages/48893.htm
http://www.albatherapeutics.com/

Cerco Medical, Inc

Uses porcine islets encapsulation into a "thin-sheet bioartificial pancreas".
http://www.isletmedical.com and/or http://cercomed.com/

2006-10-11: "if we get money soon (unlikely) and we solve the remaining problems with the Islet Sheet quickly (also unlikely) it could be a year [until human trials], but more likely 2 to 3."

The Boneyard: Cures that have failed in humans

Anti CD52 drug

http://www.clinicaltrials.gov/ct/gui/show/NCT00214214?order=178
This study has been withdrawn prior to recruitment.

Federico Gomez Children's Hospital (Rafael A Valdés-González)

This research gave birth to the Sernova work, which is active and listed above.

Treatment involves transplanting insulin producing cells and also sertoli cells to block the immune response.
None of the patients required immunosuppressant drugs to tolerate the pig tissue. Results to date (on about 20 people): about half use less insulin and two didn't need insulin at all for a period of time. But this research is very controverial.
2007-05: Report on one person who was insulin free for a few weeks and and 3 years later, the implants were still generating some insulin. abstract
2005: Abstract of 12 patient, 4 year study
http://www.theglobeandmail.com/servlet/story/RTGAM.20060905.wxdiabetes05/BNStory/specialScienceandHe

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:

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:


Page Information

  • 2 days ago [history]
  • View page source
  • You're not logged in
  • No tags yet learn more

Wiki Information

Recent PBwiki Blog Posts