Recent News Items on Curing Type-1

Recent News Items on Curing Type-1

Here are some quick notes on recent progress in human trials to cure type-1 diabetes:
I'm going to post something on Peakman's recent results in the next few days.

Tolerx Adds Europe to Phase 3 'DEFEND' Trial of Otelixizumab

This phase-III human trial has been going on for some time in the US, but they recently expanded it to Europe as well. The goal here is to drug the immune system so that more beta cells survive the immune-self attack. This is a 200+ person trial.

Press release here: http://sev.prnewswire.com/medical-pharmaceuticals/20090310/NE8064810032009-1.html

More info:
http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#TRX4alsoknownasChAglyCD3byToleRx
http://cureresearch4type1diabetes.blogspot.com/search/label/Osiris

Andromedia (Home of DiaPep227) gets $10 million from Teva

This is the longest running phase-III clinical trial that I know of to cure type-1 diabetes. It has been going on for years, and initially the results were not promising. However, the company stuck with it (even as ownership changed hands from company to company). The most recent news still doesn't look too good to me. They had extended and expanded the trial in the hopes of getting some positive results even when the early results were not statistically significant.

However, another company, Teva, is putting in $10 million so hopefully they know more than has been released to the public, and there is good news in there, somewhere.
News article: http://uk.reuters.com/article/rbssHealthcareNews/idUKLI48804120090218

Diamyd Now has four (or five) clinical trials going at once

By my count Diamyd now has five 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.
2. They have a "twin" phase-III clinical trial being done in Europe with another 300+ patients.
3. 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).
4. They have phase-II clinical trial aimed at both preserving existing insulin production and regrowing new beta cells (a possible non-honymoon cure).
5. 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.

Newspaper articles / press releases:
http://drugdiscovery.pharmaceutical-business-review.com/news/diamyd_medical_wins_swedish_approval_for_diabetes_vaccine_study_100309
http://www.msnbc.msn.com/id/29220725/

More info:
http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#DiamydTbyDiamyd
http://cureresearch4type1diabetes.blogspot.com/search/label/Diamyd

Osiris Therapeutics's PROCHYMAL in the news

This is the same research that Kimberly Wainscoat asked about. Osiris has been running a phase-II trial since mid last year. Their PROCHYMAL treatment has been show safe in several phase-I, II, and even III trials for several immune diseases, so they are trying it with type-1 diabetes. This is an adult (actually self) stem cell treatment. Since safety is established, they went straight to phase-II clinical trials. It appears that they are either ramping up recruitment of patients, or ramping up PR of the trial. Recently there have been very similar "public interest / human face" type newspaper articles on this trial, links below:

http://www8.utsouthwestern.edu/utsw/cda/dept353744/files/519415.html
http://news.cincinnati.com/apps/pbcs.dll/article?AID=2009903100368

More info:
http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#PROCHYMALbyOsirisTherapeutics
http://cureresearch4type1diabetes.blogspot.com/search/label/Osiris

Joshua Levy

Osiris Therapeutics has started a Phase II trial

Osiris Therapeutics has started a Phase II trial of their Prochymal cure for type-1 diabetes. This is an adult stem cell based cure, which has already completed Phase I and II trials and is undergoing Phase III trials targeting other immune diseases, such as Crohn's and Organ Rejection, etc. I think it is being tested on 6 or so different diseases right now. The company's description is this: "Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors."

The trial is 60 people, all within 16 weeks of initial diagnosis. It started in June 2008 and is expected to end in June 2010. The study is being done in Tennessee, and is partly funded by JDRF. Here is the company's description: "The design will be a double-blind, placebo-controlled trial at multiple sites with a target enrollment of 60 patients, and patients will be randomized to either Prochymal or placebo at a 2:1 ratio. The primary endpoint of the trial will be the measurement of C-peptide produced during a Mixed Meal Tolerance Test in patients treated with Prochymal, compared to those receiving placebo."

As far as I know, this is the first Phase II human trials for any stem cell based cure for type-1 diabetes. So it represents a whole new approach to a cure, into Phase II trials. Very good news.

For more information:
http://www.medicalnewstoday.com/articles/112956.php
http://www.osiris.com/clinical_trials_prochymal_t1d.php
http://www.osiris.com
http://clinicaltrials.gov/ct2/show/NCT00690066