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.

 

The Boneyard: Possible cures that are not active now Alba Therapeutics Anti CD52 drug E1 and G1 by Transition Therapeutics Efalizumab (tradename "RAPTIVA") Federico Gomez Children's Hospital (Rafael A Valdés-González) Microislet NBI-6024 by Neurocrine Biosciences Novocell Reneuron (was Amcyte) Swedish Study

 

 

 

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/

 

 

Anti CD52 drug

http://www.clinicaltrials.gov/ct/gui/show/NCT00214214?order=178

This study has been withdrawn prior to recruitment.

 

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

 

Efalizumab (tradename "RAPTIVA")

 

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

 

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.)

 

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

 

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”

 

History:

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.

 

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 pancreas. So these guys were cured by removing cells from an uninfected part of their own pancreas, 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