Possible Diabetes Cures Ready For Human Trials
Last update: 2009-11-22 (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, 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 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 joshua2levy@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. :-)
If you want to know when these treatments will be ready for use: WhenWillTreatmentsBeReady and Understanding the Research Funnel.
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 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
Studies you can Participate In
Several people have asked me about studies that they can participate in. So here is a list of studies that are entrolling new participants. Listing here just means that I know it exists; it does not imply that I think a study is good or safe or you should participate in it. Being a patient in a clinical trial always involves risk, and requires careful consideration.
The JDRF recently set up a great portal to help you find studies to participate in!
Specific studies recruiting now for recently diagnosed diabetics: ToleRx's DEFEND, Diamyd (US), Diamyd (EU), Andromedia's DiaPep227, Osiris, MacroGenic's Protégé, AbATE, START,
Specific studies recruiting now for established diabetics: Trucco, Bayhill's BHT-3021
Places to look for studies: US FDA List of Clinical Trials (search for "type-1 diabetes" and click on the link that "Hides studies not seeking new volunteers"), ITN (Immune Tolerance Network), UK Study Site, Internationa (WHO) Study Site.
You can also search for studies in some metro areas: Stanford San Francisco Denver.
Recent Changes
2009-08
2009-07
- Osiris
- BHT-3021
- Alba (to the boneyard)
- LCT
- MacroGenics
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 Started Phase-III Trails
DiamydT (or GAD65) by Diamyd
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.
My Blog Entries on Diamyd
Diamyd Fan Blog
By my count Diamyd now (2009-03) has six different clinical trials going all at once:
- 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
- They have a "twin" phase-III clinical trial being done in Europe with another 300+ patients. Clinicaltrial Record
- There is a NIDDK phase-II/III clinical trial which is very similar to the studies above. Clinicatrial Record
- 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).
- 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
- They have a phase-II clinical trial aimed at preventing type-1 diabetes by giving the treatment to people at high risk of type-1, but who have not shown symptoms as yet.
- 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:
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.)
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
TRX4 (also known as ChAglyCD3) by ToleRx
Not publicly traded www.tolerrx.com.
This is an anti-CD3 technique that directly competes with MacroGenics.
My Blog Entries on ToleRx
More information here: http://www.tolerrx.com/pipeline-trx4.php
Completed phase I and II; started phase III
2009-03-11: Phase-III clinical trial expands to Europe. Read the press release.
2008-10-17: Phase III clinical trial for new-onset diabetics, called DEFEND, started in 2008-05 and is expected to finish in 2010-12. clinical trial record This is a big trial: 240 people in 35 locations being followed for 2 years. more information
2008-06-03: Tolerx announced some non-clinical results press release
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."
Diapep 277 (or hsp60) by Andromeda
http://andromedabio.com
Venture Capital Funded, not publicly traded
Aventis was involved in this, but I don't think it is any more.
My Blog Entries on Andromeda
Clinicaltrial Record for their phase-III trial: "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"
| Estimated Enrollment: |
500 |
| Study Start Date: |
September 2005 |
| Estimated Study Completion Date: |
September 2011 |
| Estimated Primary Completion Date: |
August 2011 (Final data collection date for primary outcome measure) |
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
Brod at University of Texas-Health Science Center
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
ClinicalTrial Record of the Phase-II Trial
Ingested Interferon-alpha in type 1 Diabetes
2009-07-01: Phase II trial results published in Diabetes Care. Press Release.
2006-04-21: Phase II trial funded.
Report on Phase I Trial
MMF/DZG by Skyler
This is a "give drugs quickly during the honeymoon period, and save some beta cells" type treatment.
This clinical trial, is officially listed as phase-III, however I can not find any previous clinical trial with either drug that was aimed at type-1 diabetes. So I'm treating it as a phase-II trial. Both drugs are already approved for treating other diseases, and both have shown good results in animals.
Funded by JDRF, ADA, and a collection of US government agencies.
Clinical Trials Record for NCT00100178
Full Protocol Description
2008-08: Phase-II data gathering finished 2008-04 and rest of trial supposed to end in 2009-01.
2004-07: Phase-II study starts. 180 people divided into three groups: MMF, MMF and DZB and neither MMF or DZB. Expected to last four years.
PROCHYMAL by Osiris Therapeutics
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 is in phase III trials for steroid refractory acute Graft vs. Host Disease (GvHD), newly diagnosed acute GvHD, and also Crohn's disease, and phase II trials for post heart attack healing and chronic obstructive pulmonary disease (COPD), in addition to type-1 diabetes.
Publicly traded company: Nasdaq: OSIR
JDRF is helping to pay for the phase II trial.
As of 2009-08, their phase-II trial is half enrolled. PROCHYMAL has not gone through phase I trials for type-1 diabetes, so there is no data from human trials on it's effect on type-1 diabetes. It was found safe in phase I trials for other diseases, so went directly into phase II trails for diabetes.
The phase-II clinical trial involves 60 who will be followed for 2 years. Clinical Trial Record
My Blog Entries on Osiris
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
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).
These guys are currently running three studies:
clinicaltrail.gov record for Protégé Estimated Enrollment: 530 Study Start Date: 2006-10 Estimated Study Completion Date: 2011-03
clinicaltrial.gov record for AbAte Estimated Enrollment: 60 Study Start Date: 2005-09 Estimated Study Completion Date: 2011-03 Main Web Page
clinicaltrial.gov record Delay Estimated Enrollment: 60 Study Start Date: 2006-06 Estimated Study Completion Date: 2009-06
Related studies: abstract
personal testimonial
2009-06-20: PROTOGE is fully enrolled.
2009-01: All studies still recruiting new patients
2008-04: All three studies are currently recruiting participants.
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."
E1 and G1 by Transition Therapeutics
I'm in the middle of updating this entry (as of 2009-01-10). Hope to finish in a week.
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 is not a honeymoon only trial: participants must have had type-1 for over a year.
This research is partly funded by JDRF http://www.jdrf.org/index.cfm?page_id=103347.
I'm not sure exactly what is going on with this treatment for type-1 diabetics. It appears to me that in the 2006-2007 timeframe, the company was plan to continue or extend their phase-II trial for both type-1 and type-2 diabetics. However, by 2008 they had only started a new phase-II trial for type-2 diabetics, and I don't see any activity aimed at type-1 diabetes.
ClinicalTrial Web Site
2009-01-10: The clinical trial record has not been updated by the company since 2006-07-24. Trial is full. Also, there is no link from the TT home page to this trial, but there are to other trials (for type-2 and Alzheimer's).
?2007-03-13: Early Phase IIa results: most used 20% or more less insulin after a 1 month treatment.
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 (from http://islet.org/forum/messages/47373.htm">press release)
?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.
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
Rituximab by Pescovitz at Indiana
This work was supported by JDRF.
wikipedia entry
A honeymoon only, phase II trial involving 87 people. clinicaltrials.gov record
2009-01: Phase-II trial ended in 2008-09, and Pescovitz hopes to publish results in 2009-06 at the ADA meeting in New Orleans (per. comm.)
Thymoglobulin (also known as ATG) by Gitelman
This is a "give drugs quickly during the honeymoon period, and save some beta cells" type treatment.
The phase II trial is supported by JDRF.
clinicaltrials.gov record
USF page
ITN page
Main Web Page for the START trial
My Blog Entries on Gitelman
START
"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.
Abatacept by Orban at Joslin Diabetes Center
This is a honeymoon only trial, designed to retain some beta cell functionality:
"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.
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.
Clinical Trial Record: NCT00505375
My Blog Entries on Abatacept
My Blog Entries on Orban
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
Treatments that have Started Phase-I Trials
Pioglitazone by Wilson at Stony Brook
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.
Umbilical Cord Blood Infusion by Haller and Schatz at University of Florida
"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."
Clinical Trial Record: http://clinicaltrials.gov/ct/show/NCT00305344
This study is sponsored by JDRF.
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
Diabecell by Living Cell Technologies
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.
My Blog Entries on LCT
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
BHT 3021 by Bayhill Theraputics
http://www.bayhilltherapeutics.com
BHT-3021 is a plasmid encoding proinsulin designed to tolerize the immune system to proinsulin, thereby turning off the self directed immune attack. Although developed by Bayhill Theraputics, this drug has been purchased by Genetech, and I will change the corporate name when their Phase-II study starts.
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.
My Blog Entries on Bayhill
I need to do more research on this:
clinical trial record
2009-06-10: Drug purchased by Genetech press release
2009-06-05: Interrum results from the phase-I trial published at ADA. abstract
2008-01-09: company is looking for an IPO press release
Trucco at Children’s Hospital of Pittsburgh
This is a non-honeymoon clinical trial, involving 15 people.
"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
Clinical Trails
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)
Proleukin/Rapamune by Greenbaum at Benaroya Research Institute
This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. 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.
The phase-I, 10 person trial started in 2007-08 and is expected to finish 2012-09
My Blog Entries on Greenbaum
Clinical Trial Record: NCT00525889
2008-11: Phase-I trial is still recruiting.
IBC-VS01 by Orban at Joslin Diabetes Center
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
My Blog Entries on Orban
Patent Info
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.
ATG and others by Burt at University of Sao Paulo
autologous nonmyeloablative hematopoietic stem cell transplantation
Clinical Trial Record
News Article
Full 2007 paper
Full 2008 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.
My Blog Entries on Burt
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.
Treatments that are Preparing for Phase-1 Trials
AAT by Koulmanda and Strom at Harvard
This is the result of mice experiments:
“We were able to demonstrate that treatment with AAT – an agent that dampens inflammation but does not directly inhibit T-cell activation – ablates invasive insulitis and restores euglycemia normal blood glucose concentration, immune tolerance to beta cells, normal insulin signaling and insulin responsiveness in NOD mice with recent onset type 1 diabetes,”
2008-11-07: they "hope to begin clinical trials by the end of the year." press release
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”
2009-01-08: I can not find any mention of an active clinical trial, or any record of the results of a clinical trial.
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.
Diazoxide by Grill at University Hospital of Trondheim
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.
White at Sernova
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.
Bristol Vaccine by Peakman at King's Collage
This entry needs a major update (as of 2009-01-12).
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.
2009-03-15: Results are in from the phase-I clinical trial, and you can read the abstract. My 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
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."
BCG by Nathan and Faustman at BGH / Harvard
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 until end of 2008 by "Join Lee Now"
My comments on Faustman's research.
http://cureresearch4type1diabetes.blogspot.com/search/label/Faustman">My Blog Entries on Faustman
http://www.faustmanlab.org/">Faustman Lab's Web Page
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".
Novocell
http://www.novocell.com/clinical_trials.htm
This company is privately funded.
Sometime in 2007 or early 2008 they completely changed their focus from using human islet cells to growing them from stem cells. Previously, they had gotten to 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
2008-07-20: 3-4 years away from human trials. Maybe. Newspaper Article (this article is very unusual, in that it discusses risks)
(from here down deals with their older, human islet 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.
2006-05-31: JDRF is helping to fund this work
2006-04-19: In Phase 1 trails.
Gov Summary of Trial
The Boneyard: Possible cures that are not active now
This boneyard does NOT mean something has failed or has been proven not to work. It just means there are no clinical trials planned, underway, or being worked on.
Some of these trials have led to new lines of research that are still active.
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.
2009-07-16: I can not find any mention of type-1 diabetes on their web page, so I'm moving Alba to the boneyard.
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/
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.
2009-01-06: Company officially declared bankruptcy.
2008-11-13: Company is filing for chapter 11 bankruptcy newsgroup discussion
2007-12-13: press release
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
NBI-6024 by Neurocrine Biosciences
This possible treatment abruptly dropped off" Neurocrine Bioscience's rader between the second quarter of 2006 and the third quarter, just as the phase-II results were coming in.
Failed phase-II testing:
NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate statistically significant efficacy compared with placebo.
(From the clinicaltrails record.)
Swedish Study
This research was based on people who did not have type-1 (immunue related diabetes). They had functional diabetes based on an infection of their pancrease. So these guys were cured by removing cells from an uninfected part of their own pancrease, and reimplanting them. Usually this is done in the liver, but these guys put it in the arm (as is done for some other organ's tissues). Anyway, it is not of interest to type-1 diabetics.
2007-07-24: newspaper article
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:
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:
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