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

More Data on Bayhill's Phase I trial

I just poked around the Bayhill's web site a little. They are in the middle of a Phase-I trial aimed at curing type-1 diabetes. I noticed two pieces of very good news, and added both to my status page on cure research.

First, they have some data from the clinical trial that is on going right now, and that data looks very promising. This is the exact quote from their web page:

In the BHT-3021 phase I/II trial, nine patients have been randomized to the 1 mg dose cohort to date. BHT-3021 has demonstrated safety and tolerability, with no increase in adverse events among the first nine patients relative to placebo. Preliminary data also indicated that after the initiation of dosing with 1 mg of BHT-3021, there was a rapid reduction of approximately 50% in titers of anti-insulin antibodies that was sustained throughout the dosing period. In contrast, the anti-insulin antibody titers were unchanged with placebo dosing. Autoimmune T cell data from these initial patients are pending at this time.

Second, this trial is open to people who have had type-1 diabetes for any length of time. It is not "honeymoon" only, as so many are.

Check out the status of this, and all the other type-1 cure research that I track by clicking on the "Status of Research Discussed" to the right.

Hopeful Comments on Honeymoon Cures Becoming Cures for Everyone

Most research aimed a curing type-1 diabetes is focused on people in the "honeymoon" phase. People who have had type-1 for 3 months or less (or sometimes out to 6 months). In the past (before 2007) I was very nervious about these cures. I was afraid that if they worked, research into curing long term diabetes would stop, since there would not be a new pool of customers. However, recently I have come to a different conclusion. I now think that it is very likely that cures for type-1 diabetes will start out working on "honeymoon" diabetics, but end up being refined or augmented to work for all diabetics. Why?

• Some recent research suggests that the pancrease is always making new cells, and the immune system is always killing them. If so, then even long term diabetics will slowly be cured with these treatments.
• There are several research areas trying to make the pancrease grow new cells. Currently, these are not considered promising, because the immune system would just kill the new cells. But if any of these cures work for honeymooners, then they could be paired with a cell growth treatment for a cure for long term type-1 diabetics. Such growth factors include human growth hormone, INGAP, etc.

Remember that once a drug is approved for any one purpose, that drug can be proscribed by a doctor for any other purpose. This is called "off label" prescription. If if any of these cures are approved even just for honeymooners, then some doctor, somewhere is going to prescribe it to non-honeymooners, and we will all quickly learn what happens.

New Phase III Trial Starts: Otelixizumab from Tolerx

Good news! A new Phase III trial has started to test a honeymoon cure for type-1 diabetes!
You can read about it (from a technical point of view) here:
DEFEND Trial

Basically, this is a CD3 targeting drug, very similar toTeplizumab by MacroGenics. It is only being tested on honeymoon phase diabetics, but remember my hopeful comments on honeymoon cures becoming cures for everyone. This drug has been in phase II trials for a while, as has Teplizumab.

Press Release Reporting this (see the last paragraph)